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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
experimental Fit-program
no intervention
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring exercise, education, self-management, rehabilitation

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Medical Center Groningen, Center for Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

fit-program

waiting list control group

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 2, 2011
Last Updated
January 21, 2022
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT01307787
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
exercise, education, self-management, rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fit-program
Arm Type
Experimental
Arm 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.
Arm Title
waiting list control group
Arm Type
Other
Arm Description
The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
Intervention Type
Other
Intervention Name(s)
experimental Fit-program
Other Intervention Name(s)
rehabilitation
Intervention 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. 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
Intervention Name(s)
no intervention
Other Intervention Name(s)
rehabilitation
Intervention Description
waiting list control group with no intervention
Primary Outcome Measure Information:
Title
Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness
Description
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).
Time Frame
baseline, postintervention at 9 weeks
Secondary Outcome Measure Information:
Title
Change in Self-efficacy Pain and Other Symptoms
Description
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.
Time Frame
baseline, postintervention at 9 weeks,
Title
Change in Self-efficacy Function
Description
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.
Time Frame
baseline, postintervention at 9 weeks,
Title
Change in Muscle Strength of the Upper Extremity
Description
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.
Time Frame
baseline, postintervention at 9 weeks,
Title
Change in Muscle Strength of the Lower Extremity
Description
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.
Time Frame
baseline, postintervention at 9 weeks,
Title
Change in Health Status: Physical Health
Description
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.
Time Frame
baseline, postintervention at 9 weeks,
Title
Change in Health Status: Psychological Health
Description
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.
Time Frame
baseline, postintervention at 9 weeks,
Title
Change in Health Status: Social Interaction
Description
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.
Time Frame
baseline, postintervention at 9 weeks,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen van Weert, phd
Organizational Affiliation
UMCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen, Center for Rehabilitation
City
Haren
State/Province
Groningen
ZIP/Postal Code
PO box 30 002
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21474637
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.
Results Reference
derived

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

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