Trial Outcomes & Findings for Functional Movement Retraining After Hip Replacement (NCT NCT01878175)
NCT ID: NCT01878175
Last Updated: 2017-02-28
Results Overview
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
COMPLETED
NA
15 participants
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
2017-02-28
Participant Flow
Participant milestones
| Measure |
Functional Movement Retraining
15-week rehabilitation / exercise intervention, including visits at VA medical center, in-home with clinical personnel, and via telephone. Intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program focuses on lower extremity mobility, muscle stability and functional movement patterns. Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week.
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Functional Movement Retraining
15-week rehabilitation / exercise intervention, including visits at VA medical center, in-home with clinical personnel, and via telephone. Intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program focuses on lower extremity mobility, muscle stability and functional movement patterns. Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week.
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Overall Study
Developed contraindicated health problem
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2
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Baseline Characteristics
Functional Movement Retraining After Hip Replacement
Baseline characteristics by cohort
| Measure |
Functional Movement Retraining
n=15 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Age, Continuous
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66.4 years
STANDARD_DEVIATION 6.6 • n=5 Participants
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Gender
Female
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3 Participants
n=5 Participants
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Gender
Male
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12 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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6 Participants
n=5 Participants
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Race (NIH/OMB)
White
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9 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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15 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Individuals who completed the HOOS ADL scale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=13 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Activities of Daily Living Scale
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-6.00 units on a scale
Standard Deviation 6.37
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PRIMARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed the HOOS pain subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=13 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Pain Scale
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-2.12 units on a scale
Standard Deviation 9.78
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PRIMARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed the HOOS Sport subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete all items on this subscale at both time points and therefore could not be given a score, per scale scoring instructions.
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=12 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Sport Subscale
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-20.8 units on a scale
Standard Deviation 23.89
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PRIMARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed the HOOS Symptoms subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=13 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Symptom Subscale
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-2.69 units on a scale
Standard Deviation 10.33
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PRIMARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed the HOOS Quality of Life scale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=13 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change Hip Disability and Osteoarthritis Outcomes (HOOS) - Quality of Life Subscale
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-9.13 units on a scale
Standard Deviation 22.48
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SECONDARY outcome
Timeframe: Change between Pre-intervention (post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed the measure at baseline and 15 weeks. Two participants were withdrawn before 15 weeks.
This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity osteoarthritis (OA), including stair-climbing, walking, doing housework (light and heavy), and lifting and carrying. The scale range is -15 to +15, with higher scores indicating more satisfaction with function. Change was defined as post-intervention minus pre-intervention. Therefore a positive change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=13 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Satisfaction With Physical Function Questionnaire
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4.14 units on a scale
Standard Deviation 1.63
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SECONDARY outcome
Timeframe: 15 weeks (post-intervention)Population: Number of participants who completed this measure at 15 week follow-up. Two participants were withdrawn from the study before 15 weeks, and two additional participants did not complete this item at the 15 week follow up assessment.
We will use the Patient Global Impression of Change scale to evaluate participants' perspectives on overall change in their joint pain in their (one) operative hip during the study period. This single-item measure asks participants to describe their change in pain on a rating scale with the following 13 options: a little worse, somewhat worse, moderately worse, a good deal worse, a great deal worse, a very great deal worse, about the same, a little better, somewhat better, moderately better, a good deal better, a great deal better, a very great deal better. The total scale range is -6 to +6. Negative scores indicate greater perceived improvement.
Outcome measures
| Measure |
Functional Movement Retraining
n=11 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Global Assessment of Hip Symptom Change
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-5.09 units on a scale
Standard Deviation 0.83
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SECONDARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed this test at both 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this assessment at both time points.
The timed get up-and-go test has demonstrated excellent reliability and correlates well with other standard measures such as gait speed, self-report and clinical report indices of function, and is predictive of who can safely ambulate. This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Participants are asked to complete this as quickly and safely as possible, without the use of an assistive device. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=12 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Objective Functional Test: Timed Get Up-and-go
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1.23 seconds
Standard Deviation 5.56
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SECONDARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed this test at 6 and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and two additional participants did not complete this test at both time points.
The Sit-to-Stand Test has been reported to be a good indicator of postural control, fall risk, lower-extremity strength, and disability. During the sit-to-stand test participants will be asked to place their arms across their chest and keep their feet flat on the floor. They will then be asked to stand up and sit down 5 times as fast as they can. This will be repeated twice and the scores will be averaged for analysis. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=11 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Objective Functional Test: Sit to Stand
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-0.55 seconds
Standard Deviation 2.33
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SECONDARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed this test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this test at both time points.
Gait speed is a global measure of disability and function and has been correlated with disease processes, fitness level, activities of daily living, and emotional states. In addition, gait speed is an imperative measure for integration to safe and effective community ambulatory status, and has been defined as a reflective measure of function. Walking speed will be determined as the average walking speed over a 3 meter walk. Participants will be asked to walk down a 10 meter walkway 7 times (while wearing standard footwear) to have their walking speed monitored using infrared photocells, while speed is monitored over the middle 3 meters. These seven trials will be averaged in order to determine walking speed at each of the three visits. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=12 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Objective Functional Test: Walking Speed
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0.05 m/sec
Standard Deviation 0.30
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SECONDARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed this measure at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this test at both time points.
The task of stair climbing has been found to be sensitive to change with interventions in individuals with knee OA. This measures the time it takes a participant to ascend and descend a flight of 12 steps (each step 18 cm high and 28 cm deep). Participants will be asked to complete the test as quickly as they felt safe and comfortable. The use of one handrail will be allowed if necessary, but patients will be encouraged to minimize their use of the handrail. One practice trial will be performed and the average of two additional tests will be used for analysis. The use of an assistive device will be allowed only if the subject will be unsafe or cannot complete the test without the use of the device. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=12 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Objective Functional Test: Stair Climbing
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3.56 seconds
Standard Deviation 7.65
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SECONDARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed the test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.
The UCLA scale shows a strong correlation with the other measures (r = -0.35 to 0.56 for THA; r = -0.55 to 0.23 for TKA) and discriminates between insufficiently and sufficiently active patients undergoing THA and TKA. The UCLA scale has good reliability, provides high completion rate, and shows no floor effects. It seems to be the most appropriate scale for assessment of physical activity levels in patients undergoing total joint arthroplasty. The UCLA scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as 'no physical activity, dependent on others' and 10 defined as 'regular participation in impact sports.' Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=13 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in University of California Los Angeles (UCLA) Activity Questionnaire
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-0.38 units on a scale
Standard Deviation 1.80
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SECONDARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who completed the test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.
The HHS is the most widely used physician- or therapist-assessed measure of hip function following THA and associated rehabilitation. Although the HHS has also been used in a patient-report format, in this study we will obtain this measure via therapist report, to complement the patient-reported outcomes described above. This measure covers the domains of pain (severity and effects on activities and need for pain medication, function (daily activities and gait), deformity (hip flexion, adduction, internal rotation, and extremity length discrepancy) and range of motion (hip flexion, abduction, internal and external rotation, and adduction). The HHS includes 10 items, with a total score range of 0-100; higher scores indicating better function. The HHS has been shown to be a reliable and valid measure of hip function. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Outcome measures
| Measure |
Functional Movement Retraining
n=13 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Harris Hip Score (HHS)
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-10.5 units on a scale
Standard Deviation 15.67
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SECONDARY outcome
Timeframe: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)Population: Number of participants who performed the clearance test for the YBT-LQ at both 6 weeks and 15 weeks.
The YBT-LQ is a test of dynamic balance in unilateral stance . It will be administered to all patients who pass a clearance test, which consists of being able to stand on one leg for 10 seconds. The YBT-LQ is performed for both left and right limbs. Any trial that is failed will be repeated with a maximum of 4 additional trials to be performed in each reach direction, anterior, posterior, and lateral. NOTE: Only although 13 participants began the clearance test at both time points, only 5 participants were able to pass the clearance test required to do the YBT-LQ at 6 weeks. Therefore we have not provided a change score for YBT-LQ since this would involve a very small number of participants, and we are concerned about validity of the results that would be presented since those who completed the test at 6 weeks may be a biased sample. We therefore provide the difference (post minus pre) in the # of participants who completed the clearance test at 15 weeks (9) vs. 6 weeks (5).
Outcome measures
| Measure |
Functional Movement Retraining
n=13 Participants
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Change in Lower Quarter Y-balance Test (YBT-LQ)
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4 Number of participants
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Adverse Events
Functional Movement Retraining
Serious adverse events
| Measure |
Functional Movement Retraining
n=15 participants at risk
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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Psychiatric disorders
Inpatient Hospitalization
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6.7%
1/15 • Number of events 1 • Participants' duration of study participation (approximately 15 weeks following surgery)
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Other adverse events
| Measure |
Functional Movement Retraining
n=15 participants at risk
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
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|---|---|
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Injury, poisoning and procedural complications
Emergency Room Visit
|
6.7%
1/15 • Number of events 1 • Participants' duration of study participation (approximately 15 weeks following surgery)
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Infections and infestations
Emergency Room Visit
|
6.7%
1/15 • Number of events 1 • Participants' duration of study participation (approximately 15 weeks following surgery)
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Immune system disorders
Emergency Room Visit
|
6.7%
1/15 • Number of events 1 • Participants' duration of study participation (approximately 15 weeks following surgery)
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Cardiac disorders
Emergency Room Visit
|
6.7%
1/15 • Number of events 1 • Participants' duration of study participation (approximately 15 weeks following surgery)
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Musculoskeletal and connective tissue disorders
Emergency Room Visit
|
6.7%
1/15 • Number of events 1 • Participants' duration of study participation (approximately 15 weeks following surgery)
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Injury, poisoning and procedural complications
Emergency Room
|
13.3%
2/15 • Number of events 2 • Participants' duration of study participation (approximately 15 weeks following surgery)
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Injury, poisoning and procedural complications
Doctor Visit
|
6.7%
1/15 • Number of events 1 • Participants' duration of study participation (approximately 15 weeks following surgery)
|
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General disorders
Emergency Room Visit
|
6.7%
1/15 • Number of events 1 • Participants' duration of study participation (approximately 15 weeks following surgery)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place