Effects of a Group-based Exercise and Educational Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis: a Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- University Medical Center Groningen
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •medical diagnosis of RA according to the American College of Rheumatology (ACR) criteria
- •between 18 and 66 years of age
Exclusion Criteria
- •severe disease activity (Disease Activity Score:DAS-28 \> 5.1)
- •cardiac or pulmonary diseases resulting in restrictions in their ability to follow a physical exercise program
- •a Steinbrocker classification of functional capacity in RA ≥ 3
- •no stable medication for the RA
- •intra-articular injections during the time of the study
Outcomes
Primary Outcomes
Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness
Time Frame: baseline, postintervention at 9 weeks
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).
Secondary Outcomes
- Change in Self-efficacy Pain and Other Symptoms(baseline, postintervention at 9 weeks,)
- Change in Muscle Strength of the Lower Extremity(baseline, postintervention at 9 weeks,)
- Change in Self-efficacy Function(baseline, postintervention at 9 weeks,)
- Change in Muscle Strength of the Upper Extremity(baseline, postintervention at 9 weeks,)
- Change in Health Status: Psychological Health(baseline, postintervention at 9 weeks,)
- Change in Health Status: Social Interaction(baseline, postintervention at 9 weeks,)
- Change in Health Status: Physical Health(baseline, postintervention at 9 weeks,)