Trial Outcomes & Findings for Effects of a Rehabilitation Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis. (NCT NCT01307787)
NCT ID: NCT01307787
Last Updated: 2022-01-28
Results Overview
maximum oxygen uptake(VO2max, in ml/min/kg)was determined using the Åstrand-Rhyming test.The workload on the cycle ergometer was increased every minute by 25 watts until a steady-state heart rate was achieved. Participants had to sustain cycling for about 6 minutes, the heart rate(HR) was taken every minute. Mean HR of the 5th and 6th minute was registered. With the given workload, observed HR and participants'weight, maximal oxygen uptake can be established using the Åstrand-Rhyming nomogram. Values vary from \< 21( sedentary with disease) to \> 57 ( very good physical condition).
COMPLETED
NA
34 participants
baseline, postintervention at 9 weeks
2022-01-28
Participant Flow
A Rheumatologist referred people diagnosed with RA to the rehabilitation department if they had complaints concerning their physical performance or if they experienced problems with the daily management of their illness. Referred participants were independent and living at home. They did not include residents of nursing homes.
A total of thirty-nine individuals were referred for this study. Thirty-four individuals returned a signed Informed Consent form and five decided not to participate for a variety of reasons.(Impairment due to trauma n = 1 Not able to follow the program n = 1 Personal reasons n = 3)
Participant milestones
| Measure |
Fit-program
Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.
The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level.
|
Waiting List Control Group
The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
15
|
|
Overall Study
T1= After 9 Weeks Post Intervention
|
18
|
15
|
|
Overall Study
T2= After 22 Weeks at Follow-up
|
17
|
15
|
|
Overall Study
COMPLETED
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Fit-program
Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.
The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level.
|
Waiting List Control Group
The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Effects of a Rehabilitation Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis.
Baseline characteristics by cohort
| Measure |
Fit-program
n=19 Participants
Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.
The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level.
|
Waiting List Control Group
n=15 Participants
The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
Total
n=34 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
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
51.8 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
48 years
STANDARD_DEVIATION 11.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
19 participants
n=99 Participants
|
15 participants
n=107 Participants
|
34 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, postintervention at 9 weeksPopulation: Some VO2 max data (n=4 in the intervention group and n=2 in the WLC group)could not be collected because of specific participant conditions at different testing time points. 4 subjects did not reach the necessary heart rate to estimate the VO2 max. One subject had hypertension and one subject had knee problems.
maximum oxygen uptake(VO2max, in ml/min/kg)was determined using the Åstrand-Rhyming test.The workload on the cycle ergometer was increased every minute by 25 watts until a steady-state heart rate was achieved. Participants had to sustain cycling for about 6 minutes, the heart rate(HR) was taken every minute. Mean HR of the 5th and 6th minute was registered. With the given workload, observed HR and participants'weight, maximal oxygen uptake can be established using the Åstrand-Rhyming nomogram. Values vary from \< 21( sedentary with disease) to \> 57 ( very good physical condition).
Outcome measures
| Measure |
Intervention Fit Program
n=15 Participants
An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
|
Waiting List Control Group
n=13 Participants
No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
|---|---|---|
|
Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness
|
3.82 ml/min/kg
Standard Deviation 3.86
|
-0.44 ml/min/kg
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: baseline, postintervention at 9 weeks,Population: per protocol 2 subjects( n=2) in the intervention fitprogram withdrew from the study
Self-efficacy was assessed by the Arthritis-Self-efficacy Scale Dutch version. This arthritis self-efficacy scale contains two sub scales: self-efficacy pain (5 items related to coping with pain, and self-efficacy other symptoms (6 items related to coping with other symptoms, such as depression, fatigue and frustrations.A five-point ordinal scale is used ranging from 'totally disagree' (1) to 'totally agree' (5). We computed a mean score of 11 items ranging from 1-5. A higher score refers to higher self-efficacy.
Outcome measures
| Measure |
Intervention Fit Program
n=17 Participants
An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
|
Waiting List Control Group
n=15 Participants
No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
|---|---|---|
|
Change in Self-efficacy Pain and Other Symptoms
|
0.42 units on a scale
Standard Deviation 0.71
|
0.28 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: baseline, postintervention at 9 weeks,Population: analysis per protocol, 2 subjects(n=2) in the intervention fitprogram withdrew from the study.
Self-efficacy function was assessed by the Arthritis-Self-efficacy Scale Dutch version The subscale self-efficacy function contains 8 items related to physical function. A five-point ordinal scale is used ranging from 'totally disagree' (1) to 'totally agree' (5). A mean score of 8 items was computed ranging from 1-5. A higher score refers to higher self-efficacy.
Outcome measures
| Measure |
Intervention Fit Program
n=17 Participants
An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
|
Waiting List Control Group
n=15 Participants
No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
|---|---|---|
|
Change in Self-efficacy Function
|
0.29 units on a scale
Standard Deviation 0.57
|
0.10 units on a scale
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: baseline, postintervention at 9 weeks,Population: per protocol, one subject (n=1) in the intervention fitprogram withdrew from the study.
Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the elbow-flexors, elbow-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the upper extremity (UE)was computed and taken for analyses.
Outcome measures
| Measure |
Intervention Fit Program
n=18 Participants
An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
|
Waiting List Control Group
n=15 Participants
No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
|---|---|---|
|
Change in Muscle Strength of the Upper Extremity
|
36.06 newton
Standard Deviation 121.71
|
-5.49 newton
Standard Deviation 96.46
|
SECONDARY outcome
Timeframe: baseline, postintervention at 9 weeks,Population: per protocol,Lower extremity(LE) muscle strength data for one participant(n=1) in the WLC group is missing because knee problems prevented testing.
Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the knee-flexor and knee-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the lower extremity (LE)was computed and taken for analyses.
Outcome measures
| Measure |
Intervention Fit Program
n=18 Participants
An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
|
Waiting List Control Group
n=14 Participants
No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
|---|---|---|
|
Change in Muscle Strength of the Lower Extremity
|
111.20 newton
Standard Deviation 184.82
|
25.61 newton
Standard Deviation 189.30
|
SECONDARY outcome
Timeframe: baseline, postintervention at 9 weeks,Population: per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.
Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.
Outcome measures
| Measure |
Intervention Fit Program
n=17 Participants
An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
|
Waiting List Control Group
n=15 Participants
No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
|---|---|---|
|
Change in Health Status: Physical Health
|
-0.68 units on a scale
Standard Deviation 1.00
|
-0.14 units on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: baseline, postintervention at 9 weeks,Population: analysis per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.
Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.
Outcome measures
| Measure |
Intervention Fit Program
n=17 Participants
An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
|
Waiting List Control Group
n=15 Participants
No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
|---|---|---|
|
Change in Health Status: Psychological Health
|
-0.34 units on a scale
Standard Deviation 1.11
|
0.08 units on a scale
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: baseline, postintervention at 9 weeks,Population: per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.
Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.
Outcome measures
| Measure |
Intervention Fit Program
n=17 Participants
An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
|
Waiting List Control Group
n=15 Participants
No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
|
|---|---|---|
|
Change in Health Status: Social Interaction
|
-0.48 units on a scale
Standard Deviation 1.90
|
-0.88 units on a scale
Standard Deviation 2.03
|
Adverse Events
Fit-program
Waiting List 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