Effects of a Rehabilitation Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis.
Effects of a Group-based Exercise and Educational Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis: a Randomized Controlled Study
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable rheumatoid-arthritis
Started Apr 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 2, 2011
CompletedFirst Posted
Study publicly available on registry
March 3, 2011
CompletedResults Posted
Study results publicly available
May 9, 2011
CompletedJanuary 28, 2022
January 1, 2022
2.1 years
March 2, 2011
March 15, 2011
January 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
baseline, postintervention at 9 weeks
Secondary Outcomes (7)
Change in Self-efficacy Pain and Other Symptoms
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 Muscle Strength of the Lower Extremity
baseline, postintervention at 9 weeks,
Change in Health Status: Physical Health
baseline, postintervention at 9 weeks,
- +2 more secondary outcomes
Study Arms (2)
fit-program
EXPERIMENTALParticipants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
waiting list control group
OTHERThe waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
Interventions
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.
waiting list control group with no intervention
Eligibility Criteria
You may qualify if:
- medical diagnosis of RA according to the American College of Rheumatology (ACR) criteria
- between 18 and 66 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Groningen, Center for Rehabilitation
Haren, Provincie Groningen, PO box 30 002, Netherlands
Related Publications (1)
Breedland I, van Scheppingen C, Leijsma M, Verheij-Jansen NP, van Weert E. Effects of a group-based exercise and educational program on physical performance and disease self-management in rheumatoid arthritis: a randomized controlled study. Phys Ther. 2011 Jun;91(6):879-93. doi: 10.2522/ptj.20090010. Epub 2011 Apr 7.
PMID: 21474637DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
An important limitation in our study was the low number of participants included in both groups which may have induced a lack of power.
Results Point of Contact
- Title
- G.Breedland
- Organization
- UMCG
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen van Weert, phd
University Medical Center Groningen
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 2, 2011
First Posted
March 3, 2011
Study Start
April 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
January 28, 2022
Results First Posted
May 9, 2011
Record last verified: 2022-01