Rheumatoid Arthritis Clinical Trial
Official title:
A Prospective Pilot Study to Evaluate an Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis
Verified date | January 2016 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Eugen Feist |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | feasibility of the animated home-based physical exercise program | to be assessed by qualitative interview analysis | 12 weeks | Yes |
Secondary | muscle strenght measurement | isometric measurement of 9 muscle groups by using a handheld dynamometer | 12 weeks | No |
Secondary | 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 | No |
Secondary | respiratory function test | peak expiratory flow taken by a peak flow meter (liter/ Minute) | 12 weeks | No |
Secondary | Health Assessment Questionnaire Disability Indes (HAQ-DI) | standardised Patient reported outcome measurement (8 categories regarding disabilities in daily life) | 12 weeks | No |
Secondary | patient's visual analogue scale for pain | patients self-reported judgement on a 100 mm scale | 12 weeks | No |
Secondary | patient's visual analogue scale for disease activity | patients self-reported judgement on a 100 mm scale | 12 weeks | No |
Secondary | short form 36 questionnaire (SF36) | standardised patient reported outcome measurement (11categories regarding quality of life) | 12 weeks | No |
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