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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658370
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Eugen Feist, Charite University, Berlin, Germany

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: animated home-based exercises (Wii-fit) Procedure: conventional home-based exercise program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Prospective Pilot Study to Evaluate an Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis
Study Start Date : August 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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Arms and Interventions
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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 Name: 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 Name: software Wii-fit plus

Procedure: conventional home-based exercise program


Outcome Measures
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Primary Outcome Measures :
  1. feasibility of the animated home-based physical exercise program [ Time Frame: 12 weeks ]
    to be assessed by qualitative interview analysis


Secondary Outcome Measures :
  1. muscle strenght measurement [ Time Frame: 12 weeks ]
    isometric measurement of 9 muscle groups by using a handheld dynamometer

  2. 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.

  3. respiratory function test [ Time Frame: 12 weeks ]
    peak expiratory flow taken by a peak flow meter (liter/ Minute)

  4. Health Assessment Questionnaire Disability Indes (HAQ-DI) [ Time Frame: 12 weeks ]
    standardised Patient reported outcome measurement (8 categories regarding disabilities in daily life)

  5. patient's visual analogue scale for pain [ Time Frame: 12 weeks ]
    patients self-reported judgement on a 100 mm scale

  6. patient's visual analogue scale for disease activity [ Time Frame: 12 weeks ]
    patients self-reported judgement on a 100 mm scale

  7. short form 36 questionnaire (SF36) [ Time Frame: 12 weeks ]
    standardised patient reported outcome measurement (11categories regarding quality of life)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658370


Sponsors and Collaborators
Eugen Feist
Investigators
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Principal Investigator: Eugen Feist, MD Charité Berlin, Department of rheumatology and clinical immunology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eugen Feist, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02658370    
Other Study ID Numbers: EA1/189/10
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eugen Feist, Charite University, Berlin, Germany:
physical exercises
physical therapy
Wii game console
patients perspective
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases