Trial Outcomes & Findings for Comparison of Treatments Following Total Knee Replacement (NCT NCT02237911)
NCT ID: NCT02237911
Last Updated: 2019-03-11
Results Overview
WOMAC-PF is a patient reported outcome with 17 items. Each item is scored on a 5-point Likert-type Scale with descriptors from 0-4 (none, mild, moderate, severe, and extreme difficulty) and summed for a maximum score of 68. Higher scores indicate worse physical function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Baseline, 3 and 6 months
Results posted on
2019-03-11
Participant Flow
Potential subjects were identified from their surgeons' office or via public announcement in the greater Pittsburgh area, from December 2014 through February 2017. If interested in the study, subjects called the research team to obtain more information about the study, and were then screened for study eligibility.
A total of 1372 subjects called for study information: 89 could not be contacted and 1283 were screened over the telephone. From those, 1032 were not eligible/willing to participate and 251 completed in-person screening. Eleven subjects failed in-person screening, resulting in 240 eligible subjects that were randomized into one of the study arms.
Participant milestones
| Measure |
Clinic-based Outpatient Exercise Group
Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and included the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
|
Community-based Exercise Group
Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consisted of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
|
Wait-listed Usual Medical Care
Wait-listed usual medical care - no intervention provided by study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
96
|
96
|
48
|
|
Overall Study
3 Months
|
90
|
87
|
44
|
|
Overall Study
6 Months
|
89
|
88
|
45
|
|
Overall Study
COMPLETED
|
89
|
88
|
45
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
3
|
Reasons for withdrawal
| Measure |
Clinic-based Outpatient Exercise Group
Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and included the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
|
Community-based Exercise Group
Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consisted of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
|
Wait-listed Usual Medical Care
Wait-listed usual medical care - no intervention provided by study.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
Baseline Characteristics
Comparison of Treatments Following Total Knee Replacement
Baseline characteristics by cohort
| Measure |
Clinic-based Outpatient Exercise Group
n=96 Participants
Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and included exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
|
Community-based Exercise Group
n=96 Participants
Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consisted of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
|
Wait-listed Usual Medical Care
n=48 Participants
Wait-listed usual medical care - no intervention provided by study.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
70 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
70 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
70 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Education
Less than college
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Education
Complete college or technical training
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Education
Other/missing
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Marital status
Married
|
64 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Marital status
Divorced
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Marital status
Widowed
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Marital status
Never Married
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Marital status
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
30.8 kg/m^2
STANDARD_DEVIATION 5.3 • n=5 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 5.7 • n=4 Participants
|
|
Cumulative Illness Rating Scale
|
4.3 Number of comorbidities
STANDARD_DEVIATION 2.0 • n=5 Participants
|
4.4 Number of comorbidities
STANDARD_DEVIATION 1.7 • n=7 Participants
|
4.6 Number of comorbidities
STANDARD_DEVIATION 1.9 • n=5 Participants
|
4.4 Number of comorbidities
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
Total Knee Replacement Due To
Osteoarthritis
|
92 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
232 Participants
n=4 Participants
|
|
Total Knee Replacement Due To
Inflammatory Arthritis
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Surgical Knee Flexion
|
124 degrees
STANDARD_DEVIATION 11 • n=5 Participants
|
123 degrees
STANDARD_DEVIATION 11 • n=7 Participants
|
124 degrees
STANDARD_DEVIATION 10 • n=5 Participants
|
124 degrees
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Surgical knee pain
|
2.7 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 and 6 monthsPopulation: Intention-to-treat approach was used among participants with follow-up data.
WOMAC-PF is a patient reported outcome with 17 items. Each item is scored on a 5-point Likert-type Scale with descriptors from 0-4 (none, mild, moderate, severe, and extreme difficulty) and summed for a maximum score of 68. Higher scores indicate worse physical function.
Outcome measures
| Measure |
Clinic-based Outpatient Exercise Group
n=96 Participants
Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
|
Community-based Exercise Group
n=96 Participants
Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
|
Wait-listed Usual Medical Care
n=48 Participants
Wait-listed usual medical care - no intervention provided by study.
|
|---|---|---|---|
|
The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF).
6 months
|
9.8 units on a scale
Standard Deviation 7.2
|
10.8 units on a scale
Standard Deviation 7.9
|
11.8 units on a scale
Standard Deviation 7.5
|
|
The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF).
Baseline
|
20.9 units on a scale
Standard Deviation 7.9
|
20.4 units on a scale
Standard Deviation 7.4
|
20.2 units on a scale
Standard Deviation 7.9
|
|
The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF).
3 months
|
10.1 units on a scale
Standard Deviation 6.6
|
12.2 units on a scale
Standard Deviation 7.9
|
11.9 units on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsPopulation: Intention-to-treat approach was used among participants with follow-up data.
Scores on 6 performance-based tests (i.e., the 6-minute walk test, 40-meter gait speed, stair ascend/descend test, single leg stance balance test, chair stand test, and floor sitting-rising) were combined into a composite score formed with the unit-weighted Z scores of constituent tests to provide a more representative and stable measure of the subjects' underlying functional performance. The unit weights refer to averaging standardized scores (e.g., the scores for each performance-based test are converted to Z-scores before applying equal weights). Higher Z-scores represent better functional performance. The Z-scores for each participant can be interpreted as deviations from the baseline average of the whole group. We considered a change in Z-score of 0.2 as clinically important because it represents approximately 20% of a standard deviation relative to the baseline average of the whole group.
Outcome measures
| Measure |
Clinic-based Outpatient Exercise Group
n=96 Participants
Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
|
Community-based Exercise Group
n=96 Participants
Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
|
Wait-listed Usual Medical Care
n=48 Participants
Wait-listed usual medical care - no intervention provided by study.
|
|---|---|---|---|
|
Composite Score of Performed-based Tests of Physical Function.
Baseline
|
0.02 Z-score
Standard Deviation 0.8
|
-0.06 Z-score
Standard Deviation 0.8
|
-0.11 Z-score
Standard Deviation 0.7
|
|
Composite Score of Performed-based Tests of Physical Function.
3 months
|
0.49 Z-score
Standard Deviation 0.7
|
0.3 Z-score
Standard Deviation 0.8
|
0.13 Z-score
Standard Deviation 0.7
|
|
Composite Score of Performed-based Tests of Physical Function.
6 months
|
0.5 Z-score
Standard Deviation 0.8
|
0.36 Z-score
Standard Deviation 0.9
|
0.25 Z-score
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 and 6 monthsPopulation: Intention-to-treat approach was used among participants with follow-up data.
Real-time measure of daily energy expenditure physical activity assessed by portable activity monitor.
Outcome measures
| Measure |
Clinic-based Outpatient Exercise Group
n=96 Participants
Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
|
Community-based Exercise Group
n=96 Participants
Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
|
Wait-listed Usual Medical Care
n=48 Participants
Wait-listed usual medical care - no intervention provided by study.
|
|---|---|---|---|
|
Physical Activity Energy Expenditure - Measured by Portable Activity Monitor (SenseWear).
Baseline
|
511 Kcal/day
Standard Deviation 411
|
541 Kcal/day
Standard Deviation 419
|
459 Kcal/day
Standard Deviation 352
|
|
Physical Activity Energy Expenditure - Measured by Portable Activity Monitor (SenseWear).
3 months
|
566 Kcal/day
Standard Deviation 451
|
547 Kcal/day
Standard Deviation 407
|
525 Kcal/day
Standard Deviation 411
|
|
Physical Activity Energy Expenditure - Measured by Portable Activity Monitor (SenseWear).
6 months
|
538 Kcal/day
Standard Deviation 403
|
480 Kcal/day
Standard Deviation 420
|
509 Kcal/day
Standard Deviation 518
|
Adverse Events
Clinic-based Outpatient Exercise Group
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Community-based Exercise Group
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Wait-listed Usual Medical Care
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clinic-based Outpatient Exercise Group
n=96 participants at risk
Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
|
Community-based Exercise Group
n=96 participants at risk
Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
|
Wait-listed Usual Medical Care
n=48 participants at risk
Wait-listed usual medical care - no intervention provided by study.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
1.0%
1/96 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/48 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
1.0%
1/96 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
1.0%
1/96 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/48 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complication
|
1.0%
1/96 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/48 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
1.0%
1/96 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/48 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
1.0%
1/96 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
1.0%
1/96 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/48 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Vascular disorders
Thromboembolic event
|
1.0%
1/96 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
1.0%
1/96 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Skin and subcutaneous tissue disorders
Wound infection
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
0.00%
0/96 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
Other adverse events
| Measure |
Clinic-based Outpatient Exercise Group
n=96 participants at risk
Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
|
Community-based Exercise Group
n=96 participants at risk
Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
|
Wait-listed Usual Medical Care
n=48 participants at risk
Wait-listed usual medical care - no intervention provided by study.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.8%
18/96 • Number of events 18 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
17.7%
17/96 • Number of events 18 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
16.7%
8/48 • Number of events 8 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.3%
7/96 • Number of events 7 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
9.4%
9/96 • Number of events 9 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
10.4%
5/48 • Number of events 5 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal and connective tissue disorder
|
13.5%
13/96 • Number of events 13 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
13.5%
13/96 • Number of events 13 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
12.5%
6/48 • Number of events 6 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
|
Eye disorders
Cataract
|
1.0%
1/96 • Number of events 1 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
3.1%
3/96 • Number of events 3 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
|
6.2%
3/48 • Number of events 3 • The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place