An Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of this pilot study is to investigate feasibility and patients´ assessment using an animated home-based exercise program (Software Wii-fit of the Nintendo Wii game console) for patients with rheumatoid arthritis.

Official Title
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A Prospective Pilot Study to Evaluate an Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Device: animated home-based exercises (Wii-fit)
* Procedure: conventional home-based exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients fulfilling the 1987 and 2010 American College of Rheumatology (ACR) criteria for rheumatoid Arthritis Disease activity (patients' global assessment, PtGA) < 30 mm under therapy with a biological DMARD according to label Exclusion Criteria: Epilepsy Flare of RA A previous use of a Wii console for more than 5 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: animated home-based exercises (Wii-fit)<br>using the Wii game console by Nintendo | Device: animated home-based exercises (Wii-fit)<br> <br> * Other names: software Wii-fit plus;Procedure: conventional home-based exercise program<br> <br> |
| Active Comparator: conventional home-based exercise program<br>by using a compilation with 31 exercises especially for rheumatoid arthritis patients | Device: animated home-based exercises (Wii-fit)<br> <br> * Other names: software Wii-fit plus;Procedure: conventional home-based exercise program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of the animated home-based physical exercise program | to be assessed by qualitative interview analysis | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strenght measurement | isometric measurement of 9 muscle groups by using a handheld dynamometer | 12 weeks | 
| 6-minute walk test | standardised walk test (walk course with a minimum of 30 meters in length) on flat ground where patients can choose their own intensity of exercise and are allowed to stop and rest during the test. total walk distance after 6 minutes will be evaluated. | 12 weeks | 
| respiratory function test | peak expiratory flow taken by a peak flow meter (liter/ Minute) | 12 weeks | 
| Health Assessment Questionnaire Disability Indes (HAQ-DI) | standardised Patient reported outcome measurement (8 categories regarding disabilities in daily life) | 12 weeks | 
| patient's visual analogue scale for pain | patients self-reported judgement on a 100 mm scale | 12 weeks | 
| patient's visual analogue scale for disease activity | patients self-reported judgement on a 100 mm scale | 12 weeks | 
| short form 36 questionnaire (SF36) | standardised patient reported outcome measurement (11categories regarding quality of life) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical exercises, physical therapy, Wii game console, patients perspective