Effects of a Rehabilitation Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis.

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: no intervention; Other: experimental Fit-program

Study type: Interventional

Funder types: Other

Identifiers

NCT01307787

210.076

Details and patient eligibility

About

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.

Full 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).

Enrollment: 34 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

fit-program

Experimental group

Description:

Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.

Treatment:

Other: experimental Fit-program

waiting list control group

Other group

Description:

The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.

Treatment:

Other: no intervention