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

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Device: animated home-based exercises (Wii-fit); Procedure: conventional home-based exercise program

• Registration Number: NCT02658370
• Lead Sponsor: Eugen Feist

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-01
• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-15
• Last Update Submitted: 2016-01-15
• Study First Posted: 2016-01-18
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
animated home-based exercises (Wii-fit)	animated home-based exercises (Wii-fit)	using the Wii game console by Nintendo
animated home-based exercises (Wii-fit)	conventional home-based exercise program	using the Wii game console by Nintendo
conventional home-based exercise program	conventional home-based exercise program	by using a compilation with 31 exercises especially for rheumatoid arthritis patients
conventional home-based exercise program	animated home-based exercises (Wii-fit)	by using a compilation with 31 exercises especially for rheumatoid arthritis patients

Primary Outcome Measures

Name	Time	Method
feasibility of the animated home-based physical exercise program	12 weeks	to be assessed by qualitative interview analysis

Secondary Outcome Measures

Name	Time	Method
patient's visual analogue scale for pain	12 weeks	patients self-reported judgement on a 100 mm scale
6-minute walk test	12 weeks	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.
patient's visual analogue scale for disease activity	12 weeks	patients self-reported judgement on a 100 mm scale
muscle strenght measurement	12 weeks	isometric measurement of 9 muscle groups by using a handheld dynamometer
respiratory function test	12 weeks	peak expiratory flow taken by a peak flow meter (liter/ Minute)
Health Assessment Questionnaire Disability Indes (HAQ-DI)	12 weeks	standardised Patient reported outcome measurement (8 categories regarding disabilities in daily life)
short form 36 questionnaire (SF36)	12 weeks	standardised patient reported outcome measurement (11categories regarding quality of life)