Trial Outcomes & Findings for Effect of Structured Info and Adapted Exercise in OA (NCT NCT02022566)
NCT ID: NCT02022566
Last Updated: 2022-03-03
Results Overview
The level of physical activity will be monitored by a GT1M Actigraph which is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from the morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip. The account of minutes in sedentary time will be calculated and the average of minutes in one week will be used.
COMPLETED
NA
317 participants
Baseline, 3 months and 12 months
2022-03-03
Participant Flow
Because of a large drop out from the Accelerometer assessment, we recruit more participants
Participant milestones
| Measure |
Supported Self-management of Osteoarthrits Program
Treatment with an supported self-management program for osteoarthritis.
A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
|
Control Group
No intervention
|
|---|---|---|
|
Overall Study
STARTED
|
227
|
90
|
|
Overall Study
COMPLETED
|
169
|
49
|
|
Overall Study
NOT COMPLETED
|
58
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Structured Info and Adapted Exercise in OA
Baseline characteristics by cohort
| Measure |
Supported Self-management of Osteoarthrits Program
n=195 Participants
Treatment with an supported self-management program for osteoarthritis.
A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
|
Control Group
n=69 Participants
No intervention
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 10 • n=5 Participants
|
66 years
STANDARD_DEVIATION 7 • n=7 Participants
|
64 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex/Gender, Customized
female
|
125 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Sex/Gender, Customized
men
|
70 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
BMI
|
28 kg/m2
STANDARD_DEVIATION 5 • n=5 Participants
|
28 kg/m2
STANDARD_DEVIATION 5 • n=7 Participants
|
28 kg/m2
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Joint
knee
|
152 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Joint
hip
|
43 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Education
elementary school
|
47 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Education
high school
|
78 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Education
university
|
70 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Charnley Category (A=unilateral hip-OA, B=bilateral hip-OA, C=multiple joint OA
A
|
55 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Charnley Category (A=unilateral hip-OA, B=bilateral hip-OA, C=multiple joint OA
B
|
81 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Charnley Category (A=unilateral hip-OA, B=bilateral hip-OA, C=multiple joint OA
C
|
59 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sedentary daily minutes
|
562 minutes
n=5 Participants
|
572 minutes
n=7 Participants
|
565 minutes
n=5 Participants
|
|
Low activity daily minutes
|
180 minutes
n=5 Participants
|
169 minutes
n=7 Participants
|
178 minutes
n=5 Participants
|
|
Moderate-vigorous activity daily minutes
|
34 minutes
n=5 Participants
|
20 minutes
n=7 Participants
|
30 minutes
n=5 Participants
|
|
Visual Analogue Scale pain (0 to 100, 0=no pain, 100=worst imaginable pain
|
51 units on a scale
n=5 Participants
|
60 units on a scale
n=7 Participants
|
54 units on a scale
n=5 Participants
|
|
EuroQol 5 Dimension index, minimal value -0.594 (worst health), maximal value 1.00 (best health)
|
0.725 EQ-5D index
n=5 Participants
|
0.656 EQ-5D index
n=7 Participants
|
0.692 EQ-5D index
n=5 Participants
|
|
Arthritis Self-Efficacy Scale-other symptoms, Likert scale 10-100, (10 worst, 100 best)
|
68 units on a scale (10-100)
n=5 Participants
|
61 units on a scale (10-100)
n=7 Participants
|
66 units on a scale (10-100)
n=5 Participants
|
|
Arthritis Self-Efficacy Scale-pain, Likert scale 10-100, 10 worst, 100 best
|
60 units on a scale (10-100)
n=5 Participants
|
46 units on a scale (10-100)
n=7 Participants
|
58 units on a scale (10-100)
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months and 12 monthsThe level of physical activity will be monitored by a GT1M Actigraph which is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from the morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip. The account of minutes in sedentary time will be calculated and the average of minutes in one week will be used.
Outcome measures
| Measure |
Supported Self-management of Osteoarthrits Program
n=141 Participants
Treatment with an supported self-management program for osteoarthritis.
A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
|
Control Group
n=52 Participants
No intervention
|
|---|---|---|
|
Level of Physical Activity/Sedentary Time
3 months
|
556 minutes
Interval 507.0 to 602.0
|
556 minutes
Interval 504.0 to 592.0
|
|
Level of Physical Activity/Sedentary Time
baseline
|
562 minutes
Interval 523.0 to 605.0
|
572 minutes
Interval 505.0 to 599.0
|
|
Level of Physical Activity/Sedentary Time
12 months
|
552 minutes
Interval 499.0 to 598.0
|
NA minutes
The control group is only measured with baseline and 3 month follow-up
|
PRIMARY outcome
Timeframe: baseline, 3 months and12 monthsLevel of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.
Outcome measures
| Measure |
Supported Self-management of Osteoarthrits Program
n=141 Participants
Treatment with an supported self-management program for osteoarthritis.
A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
|
Control Group
n=52 Participants
No intervention
|
|---|---|---|
|
Level of Physical Activity/Low Activity
baseline
|
181 minutes
Interval 150.0 to 214.0
|
169 minutes
Interval 130.0 to 218.0
|
|
Level of Physical Activity/Low Activity
3 months
|
170 minutes
Interval 144.0 to 205.0
|
169 minutes
Interval 118.0 to 220.0
|
|
Level of Physical Activity/Low Activity
12 months
|
178 minutes
Interval 140.0 to 228.0
|
NA minutes
The control group was only had 3 month follow-up
|
PRIMARY outcome
Timeframe: baseline, 3 month and 12 monthLevel of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.
Outcome measures
| Measure |
Supported Self-management of Osteoarthrits Program
n=141 Participants
Treatment with an supported self-management program for osteoarthritis.
A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
|
Control Group
n=52 Participants
No intervention
|
|---|---|---|
|
Level of Physical Activity/Moderate-vigorous Activity
baseline
|
34 minutes
Interval 22.0 to 52.0
|
20 minutes
Interval 11.0 to 30.0
|
|
Level of Physical Activity/Moderate-vigorous Activity
3 month
|
34 minutes
Interval 19.0 to 52.0
|
21 minutes
Interval 10.0 to 37.0
|
|
Level of Physical Activity/Moderate-vigorous Activity
12 month
|
32 minutes
Interval 18.0 to 52.0
|
NA minutes
The control group only had follow-up at 3 month
|
SECONDARY outcome
Timeframe: baseline, 3 months and 12 monthsTo evaluate the health-related quality of life the EQ-5D-3L has been used. In this study, we have used the index of EQ-5D-3L with a British tariff. This scale is between (i.e., minimal value -0.594 (worst health), maximal value 1.00 (best health).
Outcome measures
| Measure |
Supported Self-management of Osteoarthrits Program
n=193 Participants
Treatment with an supported self-management program for osteoarthritis.
A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
|
Control Group
n=69 Participants
No intervention
|
|---|---|---|
|
Health Realted Quality of Life
baseline
|
0.73 eq-5d index
Interval 0.62 to 0.8
|
0.66 eq-5d index
Interval 0.16 to 0.73
|
|
Health Realted Quality of Life
3 months
|
0.73 eq-5d index
Interval 0.69 to 0.8
|
0.52 eq-5d index
Interval 0.09 to 0.73
|
|
Health Realted Quality of Life
12 months
|
0.73 eq-5d index
Interval 0.69 to 0.8
|
NA eq-5d index
The control group is only measured at baseline and 3 month follow-up
|
SECONDARY outcome
Timeframe: baseline, 3 months and 12 monthsVisual Analog Scale for Pain has been used to evaluate pain. This is a scale from 0-100 mm there higher scores indicating higher intensity of pain. We have asked for the average pain the last month.
Outcome measures
| Measure |
Supported Self-management of Osteoarthrits Program
n=195 Participants
Treatment with an supported self-management program for osteoarthritis.
A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
|
Control Group
n=69 Participants
No intervention
|
|---|---|---|
|
Visual Analog Scale for Pain
baseline
|
51 units on a scale
Interval 36.0 to 62.0
|
60 units on a scale
Interval 50.0 to 70.0
|
|
Visual Analog Scale for Pain
3 months
|
37 units on a scale
Interval 21.0 to 54.0
|
62 units on a scale
Interval 37.0 to 71.0
|
|
Visual Analog Scale for Pain
12 months
|
38 units on a scale
Interval 21.0 to 57.0
|
NA units on a scale
The control group only have 3 month follow-up.
|
SECONDARY outcome
Timeframe: baseline, 3 months and 12 monthsThe Arthritis Self-Efficacy Scale (ASES) is a widely used self-report measure of beliefs reflecting confidence in one's capacity to function despite pain and control pain or other symptoms of arthritis. ASES is scored on a 10-point Likert scale ranging from 10 (very uncertain=worst) to 100 (very certain=best).
Outcome measures
| Measure |
Supported Self-management of Osteoarthrits Program
n=193 Participants
Treatment with an supported self-management program for osteoarthritis.
A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
|
Control Group
n=69 Participants
No intervention
|
|---|---|---|
|
Arthritis Self-efficacy Scale/Pain (ASES)
baseline
|
60 units on a scale
Interval 46.0 to 76.0
|
46 units on a scale
Interval 38.0 to 62.0
|
|
Arthritis Self-efficacy Scale/Pain (ASES)
3 months
|
74 units on a scale
Interval 56.0 to 86.0
|
50 units on a scale
Interval 32.0 to 70.0
|
|
Arthritis Self-efficacy Scale/Pain (ASES)
12 months
|
68 units on a scale
Interval 46.0 to 84.0
|
NA units on a scale
Control group only followed up at 3 month
|
POST_HOC outcome
Timeframe: baseline, 3 months and 12 monthsThe Arthritis Self-Efficacy Scale (ASES) is a widely used self-report measure of beliefs reflecting confidence in one's capacity to function despite pain and control pain or other symptoms of arthritis. ASES is scored on a 10-point Likert scale ranging from 10 (very uncertain=worst) to 100 (very certain=best).
Outcome measures
| Measure |
Supported Self-management of Osteoarthrits Program
n=193 Participants
Treatment with an supported self-management program for osteoarthritis.
A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
|
Control Group
n=69 Participants
No intervention
|
|---|---|---|
|
Arthritis Self-efficacy Scale/Other Symptoms
3 months
|
76 units on a scale
Interval 61.0 to 86.0
|
56 units on a scale
Interval 46.0 to 81.0
|
|
Arthritis Self-efficacy Scale/Other Symptoms
baseline
|
68 units on a scale
Interval 53.0 to 80.0
|
61 units on a scale
Interval 48.0 to 70.0
|
|
Arthritis Self-efficacy Scale/Other Symptoms
12 months
|
71 units on a scale
Interval 55.0 to 83.0
|
NA units on a scale
Control group only followed up at 3 month
|
Adverse Events
Supported Self-management of Osteoarthrits Program
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place