An interventional study of experimental Fit-program and no intervention in Rheumatoid Arthritis, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 66 Years. Per ClinicalTrials.gov, last updated 2022-01-28.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Supportive care
The purpose of this study is to evaluate the effects of a group-based exercise and educational program for people with Rheumatoid Arthritis (RA) on physical performance and disease-self-management.
Currently, the effectiveness of a program consisting of education to improve disease self-management combined with intensive exercises is not clear. In the present study the investigators developed a group-based program for people with RA consisting of physical exercise to increase physical performance (i.e. aerobic capacity and muscle strength) combined with an educational program to improve disease self-management (self-reported health status and self-efficacy). The investigators called it the 'FIT program'. The aim of the present randomized controlled trial (RCT) was to examine the effects of the FIT program on aerobic capacity, muscle strength, self-reported health status and self-efficacy, in a population of people with RA. The investigators hypothesized that the FIT-program would have beneficial effects on physical performance (ie. aerobic capacity and muscle strength) and disease self-management (i.e. perceived health status and self-efficacy components) compared to a waiting list control group (WLCgroup).
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This study's enrollment of 34 is below the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
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Exclusion Criteria:
Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
Other: experimental Fit-program
The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
Other: no intervention
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 consisted of a muscle exercise circuit and bicycle training,sport and aqua jogging. The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals 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. Further information was given about body sensations, sports, food and energy, pain, fatigue, emotional changes, sleeping disturbance and daily routine.
Also known as: rehabilitation
waiting list control group with no intervention
Also known as: rehabilitation
Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness
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).
Time frame: baseline, postintervention at 9 weeks
Change in Self-efficacy Pain and Other Symptoms
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.
Time frame: baseline, postintervention at 9 weeks,
Change in Self-efficacy Function
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.
Time frame: baseline, postintervention at 9 weeks,
Change in Muscle Strength of the Upper Extremity
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.
Time frame: baseline, postintervention at 9 weeks,
Change in Muscle Strength of the Lower Extremity
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.
Time frame: baseline, postintervention at 9 weeks,
Change in Health Status: Physical Health
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.
Time frame: baseline, postintervention at 9 weeks,
Change in Health Status: Psychological Health
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.
Time frame: baseline, postintervention at 9 weeks,
Change in Health Status: Social Interaction
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.
Time frame: baseline, postintervention at 9 weeks,
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.
| Milestone | Fit-program | Waiting List Control Group |
|---|---|---|
| Started | 19 | 15 |
| T1= after 9 weeks post intervention | 18 | 15 |
| T2= after 22 weeks at follow-up | 17 | 15 |
| Completed | 17 | 15 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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).
| ml/min/kg | Intervention Fit Program | Waiting List Control Group |
|---|---|---|
| Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness | 3.82 ± 3.86 | -0.44 ± 2.21 |
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.
| units on a scale | Intervention Fit Program | Waiting List Control Group |
|---|---|---|
| Change in Self-efficacy Pain and Other Symptoms | 0.42 ± 0.71 | 0.28 ± 0.85 |
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.
| units on a scale | Intervention Fitprogram Group | Waiting List Control Group |
|---|---|---|
| Change in Self-efficacy Function | 0.29 ± 0.57 | 0.10 ± 0.38 |
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.
| newton | Intervention Fitprogram Group | Waiting List Control Group |
|---|---|---|
| Change in Muscle Strength of the Upper Extremity | 36.06 ± 121.71 | -5.49 ± 96.46 |
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.
| newton | Intervention Fitprogram Group | Waiting List Control Group |
|---|---|---|
| Change in Muscle Strength of the Lower Extremity | 111.20 ± 184.82 | 25.61 ± 189.30 |
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.
| units on a scale | Intervention Fitprogram Group | Waiting List Control Group |
|---|---|---|
| Change in Health Status: Physical Health | -0.68 ± 1.00 | -0.14 ± 0.49 |
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.
| units on a scale | Intervention Fitprogram Group | Waiting List Control Group |
|---|---|---|
| Change in Health Status: Psychological Health | -0.34 ± 1.11 | 0.08 ± 1.37 |
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.
| units on a scale | Intervention Fitprogram Group | Waiting List Control Group |
|---|---|---|
| Change in Health Status: Social Interaction | -0.48 ± 1.90 | -0.88 ± 2.03 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fit-program | — | — | — |
| Waiting List Control Group | — | — | — |
| Age, Categorical(Participants) | Fit-program | Waiting List Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 15 | 34 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Fit-program | Waiting List Control Group | Total |
|---|---|---|---|
| Mean | 45 ± 11.9 | 51.8 ± 9.4 | 48 ± 11.3 |
| Sex: Female, Male(Participants) | Fit-program | Waiting List Control Group | Total |
|---|---|---|---|
| Female | 12 | 12 | 24 |
| Male | 7 | 3 | 10 |
| Region of Enrollment(participants) | Fit-program | Waiting List Control Group | Total |
|---|---|---|---|
| Netherlands | 19 | 15 | 34 |
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