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

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01307787
First received: March 2, 2011
Last updated: May 11, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Other: experimental Fit-program
Other: no intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Self-efficacy Pain and Other Symptoms [ Time Frame: baseline, postintervention at 9 weeks, ] [ Designated as safety issue: No ]
    Self-efficacy was assessed by the Arthritis-Self-efficacy Scale Dutch version. This arthritis self-efficacy scale contains two sub scales: self-efficacy pain (5 items related to coping with pain, and self-efficacy other symptoms (6 items related to coping with other symptoms, such as depression, fatigue and frustrations.A five-point ordinal scale is used ranging from 'totally disagree' (1) to 'totally agree' (5). We computed a mean score of 11 items ranging from 1-5. A higher score refers to higher self-efficacy.

  • Change in Self-efficacy Function [ Time Frame: baseline, postintervention at 9 weeks, ] [ Designated as safety issue: No ]
    Self-efficacy function was assessed by the Arthritis-Self-efficacy Scale Dutch version The subscale self-efficacy function contains 8 items related to physical function. A five-point ordinal scale is used ranging from 'totally disagree' (1) to 'totally agree' (5). A mean score of 8 items was computed ranging from 1-5. A higher score refers to higher self-efficacy.

  • Change in Muscle Strength of the Upper Extremity [ Time Frame: baseline, postintervention at 9 weeks, ] [ Designated as safety issue: No ]
    Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the elbow-flexors, elbow-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the upper extremity (UE)was computed and taken for analyses.

  • Change in Muscle Strength of the Lower Extremity [ Time Frame: baseline, postintervention at 9 weeks, ] [ Designated as safety issue: No ]
    Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the knee-flexor and knee-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the lower extremity (LE)was computed and taken for analyses.

  • Change in Health Status: Physical Health [ Time Frame: baseline, postintervention at 9 weeks, ] [ Designated as safety issue: No ]
    Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.

  • Change in Health Status: Psychological Health [ Time Frame: baseline, postintervention at 9 weeks, ] [ Designated as safety issue: No ]
    Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.

  • Change in Health Status: Social Interaction [ Time Frame: baseline, postintervention at 9 weeks, ] [ Designated as safety issue: No ]
    Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.


Enrollment: 34
Study Start Date: April 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned 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.
Other: 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.
Other Name: rehabilitation
No Intervention: waiting list control group
The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
Other: no intervention
waiting list control group with no intervention
Other Name: rehabilitation

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

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307787

Locations
Netherlands
University Medical Center Groningen, Center for Rehabilitation
Haren, Groningen, Netherlands, PO box 30 002
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Ellen van Weert, phd UMCG
  More Information

No publications provided by University Medical Centre Groningen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: E.van Weert, UMCG
ClinicalTrials.gov Identifier: NCT01307787     History of Changes
Other Study ID Numbers: 210.076
Study First Received: March 2, 2011
Results First Received: March 15, 2011
Last Updated: May 11, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
exercise
education
self-management
rehabilitation

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014