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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658370
• Other study ID #: EA1/189/10
• Status: Completed
• Phase: N/A
• First received: January 13, 2016
• Last updated: January 15, 2016
• Start date: August 2011
• Est. completion date: July 2014

Study information

• Verified date: January 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• animated home-based exercises (Wii-fit)

Procedure:
• conventional home-based exercise program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eugen Feist

Outcome

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