Clinical trial NCT01307787: Effects of a Rehabilitation Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis.
Official title: Effects of a Group-based Exercise and Educational Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: exercise
education
self-management
rehabilitation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2011-03-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness
timeFrame: baseline, postintervention at 9 weeks
Secondary outcomes:
measure: Change in Self-efficacy Pain and Other Symptoms
timeFrame: baseline, postintervention at 9 weeks,
measure: Change in Self-efficacy Function
timeFrame: baseline, postintervention at 9 weeks,
measure: Change in Muscle Strength of the Upper Extremity
timeFrame: baseline, postintervention at 9 weeks,
measure: Change in Muscle Strength of the Lower Extremity
timeFrame: baseline, postintervention at 9 weeks,
measure: Change in Health Status: Physical Health
timeFrame: baseline, postintervention at 9 weeks,
measure: Change in Health Status: Psychological Health
timeFrame: baseline, postintervention at 9 weeks,
measure: Change in Health Status: Social Interaction
timeFrame: baseline, postintervention at 9 weeks,
Other outcomes:
Locations:
city: Haren
country: Netherlands
facility: University Medical Center Groningen, Center for Rehabilitation
state: Groningen
Study officials:
affiliation: UMCG
name: Ellen van Weert, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.