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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307787
• Other study ID #: 210.076
• Status: Completed
• Phase: N/A
• Start date: April 2005
• Est. completion date: May 2007

Study information

• Verified date: January 2022
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.
• no intervention
waiting list control group with no intervention

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen, Center for Rehabilitation	Haren	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Self-efficacy Pain and Other Symptoms	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.	baseline, postintervention at 9 weeks,
Secondary	Change in Self-efficacy Function	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.	baseline, postintervention at 9 weeks,
Secondary	Change in Muscle Strength of the Upper Extremity	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.	baseline, postintervention at 9 weeks,
Secondary	Change in Muscle Strength of the Lower Extremity	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.	baseline, postintervention at 9 weeks,
Secondary	Change in Health Status: Physical Health	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.	baseline, postintervention at 9 weeks,
Secondary	Change in Health Status: Psychological Health	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.	baseline, postintervention at 9 weeks,
Secondary	Change in Health Status: Social Interaction	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.	baseline, postintervention at 9 weeks,