Trial Outcomes & Findings for Resilience for Older Workers With OA Through Exercise (NCT NCT02609672)
NCT ID: NCT02609672
Last Updated: 2018-03-22
Results Overview
The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Week 1 and Week 13
Results posted on
2018-03-22
Participant Flow
Participant milestones
| Measure |
Exercise
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee osteoarthritis, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Exercise
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee osteoarthritis, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Resilience for Older Workers With OA Through Exercise
Baseline characteristics by cohort
| Measure |
Exercise
n=12 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=12 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 6.4 • n=99 Participants
|
54.9 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
53.9 years
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 1 and Week 13The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Lower Extremity Function
|
6.9 Change in scores on a scale
Standard Deviation 12.9
|
0.5 Change in scores on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Change in self-reported knee and hip pain will be assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Intermittent and Constant Osteoarthritis Pain (ICOAP) score. The KOOS and HOOS pain scores represent a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS and HOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The items from each subscale are averaged to produce a normalized ICOAP total score, ranging from 0 (no pain) to 100 (extreme pain).
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Self-reported Knee and Hip Pain
KOOS Pain
|
8.3 Change in scores on a scale
Standard Deviation 13.3
|
-1.0 Change in scores on a scale
Standard Deviation 6.4
|
|
Change in Self-reported Knee and Hip Pain
HOOS Pain
|
4.1 Change in scores on a scale
Standard Deviation 7.3
|
0.2 Change in scores on a scale
Standard Deviation 13.3
|
|
Change in Self-reported Knee and Hip Pain
ICOAP Constant
|
-20.6 Change in scores on a scale
Standard Deviation 23.1
|
-2.3 Change in scores on a scale
Standard Deviation 11.7
|
|
Change in Self-reported Knee and Hip Pain
ICOAP Intermittent
|
-26.4 Change in scores on a scale
Standard Deviation 17.2
|
3.3 Change in scores on a scale
Standard Deviation 22.0
|
|
Change in Self-reported Knee and Hip Pain
ICOAP Total Score
|
-23.8 Change in scores on a scale
Standard Deviation 18.5
|
0.8 Change in scores on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Resilience will be measured using the Resilience Scale 25 Survey, which is a 25-item questionnaire designed to evaluate a participants ability to adapt to stress and adversity. The test is scored out of 175 (scores ranging from 25 to 175), with higher scores indicating higher resilience.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Resilience
|
6.2 Change in scores on a scale
Standard Deviation 16.5
|
2.8 Change in scores on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Mobility performance will be measured using the Six-Minute Walk Test (6MWT). For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded in metres. This measure has produced reliable and valid data in persons with knee OA.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Mobility Performance (Six-Minute Walk Test)
|
12.5 Change in Metres
Standard Deviation 39.6
|
23.7 Change in Metres
Standard Deviation 54.1
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Mobility performance will be measured using the 40 Metre Walk Test. This test measures the time taken to complete a fast-paced 40 metre walk. The time taken to walk 40 metres is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Mobility Performance (40 Metre Walk Test)
|
-0.7 Change in Seconds
Standard Deviation 2.7
|
-0.1 Change in Seconds
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Mobility performance will be measured using the Stair Ascent Test. For this test, the time taken to ascend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Mobility Performance (Stair Ascent)
|
-0.4 Change in Seconds
Standard Deviation 0.6
|
0.0 Change in Seconds
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Mobility performance will be measured using the Stair Descent Test. For this test, the time taken to descend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Mobility Performance (Stair Descent)
|
-0.1 Change in Seconds
Standard Deviation 0.4
|
0.0 Change in Seconds
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Mobility performance will be measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period.This measure has produced reliable and valid data in persons with knee OA.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Mobility Performance (30-second Chair Stand Test)
|
0.2 Change in number of sit-to-stand cycles
Standard Deviation 2.4
|
-0.5 Change in number of sit-to-stand cycles
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Mobility performance will be measured using the Timed Up and Go Test. This test measures the time taken to rise from a standard chair with arm rests, walk 3 metres, and return to a seated position. This measure has produced reliable and valid data in persons with knee OA.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Mobility Performance (Timed Up and Go Test)
|
-0.5 Change in Seconds
Standard Deviation 1.0
|
0.2 Change in Seconds
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 1 and Week 13The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Each question is scored from 10 (very uncertain), to 100 (very certain), in 10-point increments. The minimum score for each subscale is 10, and the maximum score for each subscale is 100. The scores from each subscale are averaged to produce a normalized total score. Scores closer to 100 indicate greater certainty that a participant can cope with a particular task as a consequence of their disease.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Arthritis-related Self-efficacy
ASES Symptoms
|
1.6 Change in scores on a scale
Standard Deviation 2.2
|
0.9 Change in scores on a scale
Standard Deviation 1.5
|
|
Change in Arthritis-related Self-efficacy
ASES Pain
|
1.1 Change in scores on a scale
Standard Deviation 2.5
|
0.6 Change in scores on a scale
Standard Deviation 2.0
|
|
Change in Arthritis-related Self-efficacy
ASES Function
|
0.9 Change in scores on a scale
Standard Deviation 1.4
|
0.1 Change in scores on a scale
Standard Deviation 0.7
|
|
Change in Arthritis-related Self-efficacy
ASES Total
|
3.7 Change in scores on a scale
Standard Deviation 5.6
|
1.6 Change in scores on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Depression will be assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. Each item is scored from 0 (rarely or none of the time), to 3 (most of the time). The items are summed to produce a total score between 0 and 60 with a score of 16 or higher indicating depression.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Depression Status
|
-7.2 Change in scores on a scale
Standard Deviation 8.0
|
0.3 Change in scores on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg.
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Grip Strength (Absolute)
Right Side Grip Strength
|
1.1 Change in kg
Standard Deviation 2.6
|
-0.1 Change in kg
Standard Deviation 2.8
|
|
Change in Grip Strength (Absolute)
Left Side Grip Strength
|
0.4 Change in kg
Standard Deviation 3.0
|
-0.2 Change in kg
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg/kg (grip force/body mass).
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
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No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
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|---|---|---|
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Change in Grip Strength (Relative)
Right Side Normalized Grip Strength
|
0.0 Change in kg/kg
Standard Deviation 0.0
|
0.0 Change in kg/kg
Standard Deviation 0.0
|
|
Change in Grip Strength (Relative)
Left Side Normalized Grip Strength
|
0.0 Change in kg/kg
Standard Deviation 0.0
|
0.0 Change in kg/kg
Standard Deviation 0.0
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SECONDARY outcome
Timeframe: Week 1 and Week 13The peak torque developed during knee and hip extension and flexion during a maximum isometric contraction will be measured by use of a Biodex System 2 isokinetic dynamometer. Data will be presented as Nm/kg (torque/body mass).
Outcome measures
| Measure |
Exercise
n=9 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Isometric Knee and Hip Extensor and Flexor Strength
Knee Extensor Torque (Nm/kg)
|
0.1 Change in Nm/kg
Standard Deviation 0.2
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-0.1 Change in Nm/kg
Standard Deviation 0.2
|
|
Change in Isometric Knee and Hip Extensor and Flexor Strength
Knee Flexor Torque (Nm/kg)
|
0.0 Change in Nm/kg
Standard Deviation 0.1
|
0.0 Change in Nm/kg
Standard Deviation 0.1
|
|
Change in Isometric Knee and Hip Extensor and Flexor Strength
Hip Extensor Torque (Nm/kg)
|
0.1 Change in Nm/kg
Standard Deviation 0.2
|
0.1 Change in Nm/kg
Standard Deviation 0.2
|
|
Change in Isometric Knee and Hip Extensor and Flexor Strength
Hip Flexor Torque (Nm/kg)
|
0.0 Change in Nm/kg
Standard Deviation 0.1
|
0.0 Change in Nm/kg
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Week 1 and Week 13Population: Due to equipment problems, 2 participants from the Exercise Group were not able to complete the Single Stage Treadmill Walking Test.
Cardiovascular fitness will be calculated using the Single Stage Treadmill Walking Test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor), walking speed, age and gender.
Outcome measures
| Measure |
Exercise
n=7 Participants
The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
No Exercise
n=11 Participants
The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
|---|---|---|
|
Change in Cardiovascular Fitness
|
-1.3 Change in ml/kg/min
Standard Deviation 3.0
|
-1.7 Change in ml/kg/min
Standard Deviation 2.5
|
Adverse Events
Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Monica Maly
McMaster University/University of Waterloo
Phone: 519-888-4567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place