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

January 15, 2016 updated by: Eugen Feist

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eugen Feist

Investigators

  • Principal Investigator: Eugen Feist, MD, Charité Berlin, Department of rheumatology and clinical immunology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/189/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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