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

NCT ID: NCT01307787

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2007-05-31

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).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

fit-program

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

Group Type: EXPERIMENTAL

experimental Fit-program

Intervention Type: OTHER

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

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

Group Type: OTHER

no intervention

Intervention Type: OTHER

waiting list control group with no intervention

Interventions

experimental Fit-program

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.

Intervention Type: OTHER

no intervention

waiting list control group with no intervention

Intervention Type: OTHER

Other Intervention Names

rehabilitation; rehabilitation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

UMCG

Principal Investigators

Ellen van Weert, phd

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

University Medical Center Groningen, Center for Rehabilitation

Haren, Provincie Groningen, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 21474637 (View on PubMed)

Other Identifiers

210.076

Identifier Type: -

Identifier Source: org_study_id