Trial Outcomes & Findings for Improving Rehabilitation Outcomes After Total Hip Arthroplasty (NCT NCT02920866)
NCT ID: NCT02920866
Last Updated: 2024-05-21
Results Overview
Patients will perform a 6MW test, which assesses how far a patient walks in 6 minutes. The 6MW test was chosen as the primary outcome because it captures performance over a period of time that best mimics community ambulation with activities of daily living. Higher numbers indicate better function. The 6MW test is reliable and valid in the post-THA population and can detect small changes in function after THA. 6MW will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
Change in 6MW from baseline to intervention end-point (after 8 week intervention; POST2)
Results posted on
2024-05-21
Participant Flow
Participants were recruited from orthopedic clinics.
Participant milestones
| Measure |
Functional Strength Integration (FSI)
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
50
|
|
Overall Study
COMPLETED
|
41
|
45
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 participants declined to provide their sex.
Baseline characteristics by cohort
| Measure |
Functional Strength Integration (FSI)
n=45 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=50 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 7.2 • n=45 Participants
|
64.5 years
STANDARD_DEVIATION 7.0 • n=50 Participants
|
63.9 years
STANDARD_DEVIATION 7.1 • n=95 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=45 Participants • 2 participants declined to provide their sex.
|
34 Participants
n=48 Participants • 2 participants declined to provide their sex.
|
49 Participants
n=93 Participants • 2 participants declined to provide their sex.
|
|
Sex: Female, Male
Male
|
30 Participants
n=45 Participants • 2 participants declined to provide their sex.
|
14 Participants
n=48 Participants • 2 participants declined to provide their sex.
|
44 Participants
n=93 Participants • 2 participants declined to provide their sex.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=45 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=45 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=45 Participants
|
6 Participants
n=50 Participants
|
8 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=45 Participants
|
40 Participants
n=50 Participants
|
81 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=45 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=95 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=45 Participants
|
50 Participants
n=50 Participants
|
95 Participants
n=95 Participants
|
|
Body Mass Index (BMI)
|
28.9 kg/m^2
STANDARD_DEVIATION 4.8 • n=45 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 4.2 • n=50 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 4.5 • n=95 Participants
|
PRIMARY outcome
Timeframe: Change in 6MW from baseline to intervention end-point (after 8 week intervention; POST2)Patients will perform a 6MW test, which assesses how far a patient walks in 6 minutes. The 6MW test was chosen as the primary outcome because it captures performance over a period of time that best mimics community ambulation with activities of daily living. Higher numbers indicate better function. The 6MW test is reliable and valid in the post-THA population and can detect small changes in function after THA. 6MW will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=41 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=45 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
6 Minute Walk Test (6MW)
|
252.4 meters
Interval 194.2 to 310.5
|
207.0 meters
Interval 151.5 to 262.5
|
SECONDARY outcome
Timeframe: Change in 4MW from baseline to intervention end-point (after 8 week intervention; POST2)Population: The number analyzed for this outcome measure differs from the overall number analyzed due to some participants not meeting ability/safety criteria at assessment timepoint.
The 4MW test measures the time to walk 4 meters and has been used to generate gait speed values, which have been associated with morbidity and mortality in older adults. Higher numbers indicate better speed values. Participants will perform the 4MW with instructions to walk in their "normal, everyday pace." 4MW will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=40 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=45 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
4 Meter Walk (4MW)
|
-0.69 seconds
Interval -0.83 to -0.56
|
-0.54 seconds
Interval -0.67 to -0.41
|
SECONDARY outcome
Timeframe: Change in 30 STS from baseline to intervention end-point (after 8 week intervention; POST2)Population: The number analyzed for this outcome measure differs from the overall number analyzed due to some participants not meeting ability/safety criteria at assessment timepoint.
The 30 second sit-to-stand test assesses functional lower extremity strength and endurance, and has been validated and found reliable in older adults at various physical activity levels and physical independence levels. Higher numbers indicate better lower extremity strength and endurance. 30 STS will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=37 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=41 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
30 Second Sit-to-stand (30 STS)
|
4.22 number of sit to stand cycles
Interval 3.07 to 5.36
|
3.39 number of sit to stand cycles
Interval 2.3 to 4.47
|
SECONDARY outcome
Timeframe: Change in FGA from baseline to intervention end-point (after 8 week intervention; POST2)Population: The number analyzed for this outcome measure differs from the overall number analyzed due to some participants not meeting ability/safety criteria at assessment timepoint.
Participants will also perform the FGA, which is a 10-item objective outcome measure designed to measure dynamic balance while walking in the presence of external demands, and will provide information on patients' stability before and after THA. The FGA has been shown to be a reliable and valid measure, effective in classifying fall risk in older adults and predicting unexplained falls. Scores range from 0-30, with higher scores indicating better functions. FGA will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=39 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=45 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Functional Gait Assessment (FGA)
|
3.71 score on a scale
Interval 2.66 to 4.76
|
3.63 score on a scale
Interval 2.65 to 4.61
|
SECONDARY outcome
Timeframe: Change in strength from baseline to intervention end-point (after 8 week intervention; POST2)Population: The number analyzed for this outcome measure differs from the overall number analyzed due to some participants not meeting ability/safety criteria at assessment timepoint.
Isometric strength of the quadriceps and hip abductor muscles will be assessed on a handheld dynamometer. All strength testing will be performed in positions that minimize the risk of hip dislocation post-operatively, while still allowing for optimal trunk and pelvic stabilization. Isometric quadriceps strength testing will be performed in sitting at 0 hip flexion and 60 knee flexion. Isometric hip abduction strength testing will be performed in side lying at 0 flexion/extension and 0 hip abduction. Testing will include warm-up repetitions, followed by three separate maximal voluntary isometric contractions while receiving visual and verbal feedback. Strength will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=39 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=45 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Isometric Strength
Involved Hip Abductor
|
0.15 kg force/kg body mass
Interval 0.02 to 0.28
|
0.06 kg force/kg body mass
Interval -0.07 to 0.18
|
|
Isometric Strength
Uninvolved Hip Abductor
|
0.14 kg force/kg body mass
Interval 0.04 to 0.24
|
0.02 kg force/kg body mass
Interval -0.07 to 0.11
|
|
Isometric Strength
Involved Quad Strength
|
0.64 kg force/kg body mass
Interval 0.43 to 0.86
|
0.54 kg force/kg body mass
Interval 0.34 to 0.75
|
|
Isometric Strength
Uninvolved Quad Strength
|
0.31 kg force/kg body mass
Interval 0.09 to 0.53
|
0.23 kg force/kg body mass
Interval 0.03 to 0.44
|
|
Isometric Strength
Involved Hamstring
|
0.24 kg force/kg body mass
Interval 0.14 to 0.34
|
0.18 kg force/kg body mass
Interval 0.08 to 0.28
|
|
Isometric Strength
Uninvolved Hamstring
|
0.09 kg force/kg body mass
Interval -0.01 to 0.2
|
0.06 kg force/kg body mass
Interval -0.04 to 0.16
|
SECONDARY outcome
Timeframe: Change in Trendelenburg test from baseline to intervention end-point (after 8 week intervention; POST2)Population: The number analyzed for this outcome measure differs from the overall number analyzed due to some participants not meeting ability/safety criteria at assessment timepoint.
Patients will complete hip abductor endurance testing using a static single-limb balance test,. This modified Trendelenburg test assesses neuromuscular control during single limb stance and indicates the ability of the lateral hip muscles to maintain pelvic control during closed-chain, functional tasks and therefore serves as a measure of hip abductor muscle endurance. This test will be performed using a high-speed motion-capture system to assess lateral pelvic tilt. Differences in length of time pelvic control is maintained will be analyzed from preoperative to postoperative assessments during the single-limb task on the surgical leg. Trendelenburg will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=38 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=45 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Modified Trendelenburg Test
|
4.27 seconds
Interval 2.09 to 6.46
|
2.81 seconds
Interval 0.8 to 4.81
|
SECONDARY outcome
Timeframe: Change in moment from baseline to intervention end-point (after 8 week intervention; POST2)Population: The number analyzed for this outcome measure differs from the overall number analyzed due to some participants not meeting ability/safety criteria at assessment timepoint.
Surgical limb peak internal hip abduction moment will be calculated with 3-D instrumented motion analysis. Continuous internal hip abduction moments will be calculated during functional task performance using a standard inverse dynamics approach integrating kinematic and kinetic data using Visual 3D software (C-Motion, Germantown, MD). Peak internal hip moment during activity is a measurement of muscle activity during the task and provides insight to how muscles are activated during the task. Since the intervention exercise program targeted improving recruitment of the hip abductor moments during gait and other functional tasks, we calculated internal hip abduction moments. From the continuous hip moments, peak surgical limb internal hip abduction moments during the Loading Response phase of the stance period of the walking trials will be collected. Moments will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=39 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=44 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Peak Internal Hip Abduction Moment
Involved Hip Abduction Moment
|
3.44 kg force/kg body mass
Interval 1.04 to 5.84
|
0.62 kg force/kg body mass
Interval -1.62 to 2.85
|
|
Peak Internal Hip Abduction Moment
Uninvolved Hip Abduction Moment
|
3.27 kg force/kg body mass
Interval 1.23 to 5.3
|
0.42 kg force/kg body mass
Interval -1.5 to 2.32
|
SECONDARY outcome
Timeframe: Change in physical activity from baseline to intervention end-point (after 8 week intervention; POST2)Population: The number analyzed for this outcome measure differs from the overall number analyzed due to some participants not meeting ability/safety criteria at assessment timepoint.
ActiGraph activity monitors assess physical activity (PA) using accelerometry, which allows objective evaluation of the relative volume (steps/day) and intensity (activity counts) of physical activity with high validity and reliability. Each participant will wear the ActiGraph for at least 4 days at all time points to assess average daily PA (steps/day). Higher number of steps indicates higher level of physical activity. PA will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=23 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=25 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
ActiGraph
|
892 steps per day
Interval 152.0 to 1631.0
|
1014 steps per day
Interval 306.0 to 1722.0
|
SECONDARY outcome
Timeframe: Change in VR-12 from baseline to intervention end-point (after 8 week intervention; POST2)The Veterans RAND (VR-12) is a reliable, self-report survey for assessing health-related quality of life. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents' physical and psychological health status. Each component score is summarized from 0 to 100, with a higher score indicating a better outcome. VR-12 scores will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=41 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=45 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Veterans RAND 12-item Health Survey (VR-12)
Physical Component Score
|
15.2 score on a scale
Interval 12.7 to 17.7
|
16.4 score on a scale
Interval 14.0 to 18.8
|
|
Veterans RAND 12-item Health Survey (VR-12)
Mental Component Score
|
4.16 score on a scale
Interval 2.02 to 6.3
|
3.82 score on a scale
Interval 1.78 to 5.86
|
SECONDARY outcome
Timeframe: Change in WOMAC from baseline to intervention end-point (after 8 week intervention; POST2)The WOMAC is a self-report questionnaire that assesses the impact of osteoarthritis on pain, stiffness, and disability. The WOMAC has been shown to be a valid, reliable, and responsive instrument often used in clinical trials. Scores range from 0-96, with higher scores indicating more pain, stiffness, and disability. WOMAC scores will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=41 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=45 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
-35.0 score on a scale
Interval -39.2 to 30.9
|
-38.4 score on a scale
Interval -42.4 to -34.5
|
SECONDARY outcome
Timeframe: Assessed at baseline onlyPopulation: Two participants chose not to complete the survey.
The PAM survey assesses patient knowledge, skill, and confidence for self-management, as self-efficacy exhibits a positive relationship with preventive actions and health outcomes. The Continuous Score is a composite score of the available 10 items, ranging from 0-100, wherein a higher score indicates a higher activation (better outcomes). The PAM Level is the mean of the 4 Categorical Levels, wherein a higher score indicates a higher activation (better outcomes). Categorical Level 1: disengaged and overwhelmed; Categorical Level 2: becoming aware but still struggling; Categorical Level 3: taking action \& gaining control; Categorical Level 4: maintaining behaviors \& pushing further. Specific cut offs for each Categorical Level are unavailable, as scoring is proprietary.
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=44 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=49 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Patient Activation Measure (PAM)
Continuous
|
71.3 score on a scale
Standard Deviation 12.7
|
70.6 score on a scale
Standard Deviation 14.2
|
|
Patient Activation Measure (PAM)
PAM Level
|
3.34 score on a scale
Standard Deviation 0.57
|
3.27 score on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Assessed at baseline onlyPopulation: Two participants chose not to complete the survey.
The PAM survey assesses patient knowledge, skill, and confidence for self-management, as self-efficacy exhibits a positive relationship with preventive actions and health outcomes. The Categorical Levels are frequency distribution of the scores between 1-100, wherein a higher Categorical Level indicates a higher activation (better outcomes). Categorical Level 2: becoming aware but still struggling; Categorical Level 3: taking action \& gaining control; Categorical Level 4: maintaining behaviors \& pushing further. Specific cut offs for each Categorical Level are unavailable, as the scoring is proprietary.
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=44 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=49 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Patient Activation Measure (PAM) Categorical
Categorical Level 2
|
2 Participants
|
7 Participants
|
|
Patient Activation Measure (PAM) Categorical
Categorical Level 3
|
25 Participants
|
22 Participants
|
|
Patient Activation Measure (PAM) Categorical
Categorical Level 4
|
17 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Quantification at BaselineThe motivation scales asks the participant "How motivated do you feel to participate in physical therapy?", and rating on a 0 (not at all motivated) to 10 (very motivated) scale. Higher scores indicate higher level of motivation.
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=45 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=50 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Motivation Scale
|
9.42 score on a scale
Standard Deviation 1.4
|
9.28 score on a scale
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Quantification at baseline, POST1 (after 4 weeks intervention), POST2 (after 8 weeks intervention), and POST3 (26 weeks after initiating rehabilitation)Population: The number analyzed for this outcome measure differs from the overall number analyzed due to some participants not meeting ability/safety criteria at assessment timepoint.
Patients will report pain levels at rest and with activity (numerical pain rating scale \[NPRS; 0= no pain, 10= worst possible pain\]) at all testing timepoints.
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=45 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=50 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Pain Levels at Rest and With Activity
Involved Limb Pain at Rest Baseline
|
4.4 score on a scale
Standard Deviation 2.368352
|
4.62 score on a scale
Standard Deviation 2.406539
|
|
Pain Levels at Rest and With Activity
Uninvolved Limb Pain at Rest Baseline
|
1.022222 score on a scale
Standard Deviation 1.936361
|
0.7 score on a scale
Standard Deviation 1.328648
|
|
Pain Levels at Rest and With Activity
Involved Limb Pain with Activity Baseline
|
4.822222 score on a scale
Standard Deviation 2.405381
|
4.64 score on a scale
Standard Deviation 2.472378
|
|
Pain Levels at Rest and With Activity
Uninvolved Limb Pain with Activity Baseline
|
0.711111 score on a scale
Standard Deviation 1.791675
|
0.1 score on a scale
Standard Deviation 0.416497
|
|
Pain Levels at Rest and With Activity
Involved Limb Pain at Rest Post1
|
1.297297 score on a scale
Standard Deviation 1.596261
|
0.952381 score on a scale
Standard Deviation 1.305754
|
|
Pain Levels at Rest and With Activity
Uninvolved Limb Pain at Rest Post1
|
0.756757 score on a scale
Standard Deviation 1.816673
|
0.047619 score on a scale
Standard Deviation 0.308607
|
|
Pain Levels at Rest and With Activity
Involved Limb Pain with Activity Post1
|
1.108108 score on a scale
Standard Deviation 1.760426
|
0.904762 score on a scale
Standard Deviation 1.393531
|
|
Pain Levels at Rest and With Activity
Uninvolved Limb Pain with Activity Post1
|
08.10811 score on a scale
Standard Deviation 1.853493
|
0.095238 score on a scale
Standard Deviation 0.484367
|
|
Pain Levels at Rest and With Activity
Involved Limb Pain at Rest Post2
|
0.902439 score on a scale
Standard Deviation 1.462957
|
0.533333 score on a scale
Standard Deviation 0.990867
|
|
Pain Levels at Rest and With Activity
Uninvolved Limb Pain at Rest Post2
|
0.780488 score on a scale
Standard Deviation 2.07981
|
0.133333 score on a scale
Standard Deviation 0.547723
|
|
Pain Levels at Rest and With Activity
Involved Limb Pain with Activity Post2
|
0.707317 score on a scale
Standard Deviation 1.346178
|
0.555556 score on a scale
Standard Deviation 1.139289
|
|
Pain Levels at Rest and With Activity
Uninvolved Limb with Activity Pain Post2
|
0.804878 score on a scale
Standard Deviation 2.170478
|
0.044444 score on a scale
Standard Deviation 0.208409
|
|
Pain Levels at Rest and With Activity
Involved Limb Pain at Rest Post3
|
1.096774 score on a scale
Standard Deviation 1.325515
|
0.200000 score on a scale
Standard Deviation 0.531369
|
|
Pain Levels at Rest and With Activity
Uninvolved Limb Pain at Rest Post3
|
0.806452 score on a scale
Standard Deviation 1.621097
|
0.171429 score on a scale
Standard Deviation 0.513678
|
|
Pain Levels at Rest and With Activity
Involved Limb with Activity Pain Post3
|
0.580645 score on a scale
Standard Deviation 1.176837
|
0.285714 score on a scale
Standard Deviation 0.621735
|
|
Pain Levels at Rest and With Activity
Uninvolved Limb Pain with Activity Post3
|
0.451613 score on a scale
Standard Deviation 1.206613
|
0.114286 score on a scale
Standard Deviation 0.529785
|
OTHER_PRE_SPECIFIED outcome
Timeframe: POST1 (after 4 weeks intervention), POST2 (after 8 weeks intervention), and POST3 (26 weeks after initiating rehabilitation)Population: The number analyzed for this outcome measure differs from the overall number analyzed due to some participants not completing the assessment timepoint.
Patient report musculoskeletal injury history at all testing timepoints.
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=41 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=45 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Injury
Injury Post1
|
3 participants
|
5 participants
|
|
Injury
Injury Post2
|
0 participants
|
5 participants
|
|
Injury
Injury Post3
|
5 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Quantification at baseline, POST1 (after 4 weeks intervention), POST2 (after 8 weeks intervention), and POST3 (26 weeks after initiating rehabilitation)Population: The number analyzed for this outcome measure differs from the overall number analyzed due to some participants not meeting ability/safety criteria at assessment timepoint.
Patients will report falls at all testing timepoints.
Outcome measures
| Measure |
Functional Strength Integration (FSI)
n=45 Participants
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=50 Participants
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Falls
Falls Post1
|
0.108108 falls
Standard Deviation 0.3148
|
0.119048 falls
Standard Deviation 0.395239
|
|
Falls
Falls Post2
|
0.02439 falls
Standard Deviation 0.156174
|
0.088889 falls
Standard Deviation 0.358166
|
|
Falls
Falls Post3
|
0.225806 falls
Standard Deviation 0.61694
|
0.257143 falls
Standard Deviation 0.741337
|
Adverse Events
Functional Strength Integration (FSI)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Group (CON)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Functional Strength Integration (FSI)
n=45 participants at risk
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
Functional Strength Integration (FSI): FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
|
Control Group (CON)
n=50 participants at risk
Usual care, continuing education on postsurgical precautions
Control Group (CON): Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Falls
|
6.7%
3/45 • Number of events 3 • 6 months
|
6.0%
3/50 • Number of events 3 • 6 months
|
Additional Information
Dr. Jennifer Stevens-Lapsley
University of Colorado Denver
Phone: 303.724.9170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place