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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
animated home-based exercises (Wii-fit)
conventional home-based exercise program
Sponsored by
Eugen Feist
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring physical exercises, physical therapy, Wii game console, patients perspective

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    animated home-based exercises (Wii-fit)

    conventional home-based exercise program

    Arm Description

    using the Wii game console by Nintendo

    by using a compilation with 31 exercises especially for rheumatoid arthritis patients

    Outcomes

    Primary Outcome Measures

    feasibility of the animated home-based physical exercise program
    to be assessed by qualitative interview analysis

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 13, 2016
    Last Updated
    January 15, 2016
    Sponsor
    Eugen Feist
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02658370
    Brief Title
    An Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Eugen Feist

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    physical exercises, physical therapy, Wii game console, patients perspective

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    animated home-based exercises (Wii-fit)
    Arm Type
    Experimental
    Arm Description
    using the Wii game console by Nintendo
    Arm Title
    conventional home-based exercise program
    Arm Type
    Active Comparator
    Arm Description
    by using a compilation with 31 exercises especially for rheumatoid arthritis patients
    Intervention Type
    Device
    Intervention Name(s)
    animated home-based exercises (Wii-fit)
    Other Intervention Name(s)
    software Wii-fit plus
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional home-based exercise program
    Primary Outcome Measure Information:
    Title
    feasibility of the animated home-based physical exercise program
    Description
    to be assessed by qualitative interview analysis
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    muscle strenght measurement
    Description
    isometric measurement of 9 muscle groups by using a handheld dynamometer
    Time Frame
    12 weeks
    Title
    6-minute walk test
    Description
    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.
    Time Frame
    12 weeks
    Title
    respiratory function test
    Description
    peak expiratory flow taken by a peak flow meter (liter/ Minute)
    Time Frame
    12 weeks
    Title
    Health Assessment Questionnaire Disability Indes (HAQ-DI)
    Description
    standardised Patient reported outcome measurement (8 categories regarding disabilities in daily life)
    Time Frame
    12 weeks
    Title
    patient's visual analogue scale for pain
    Description
    patients self-reported judgement on a 100 mm scale
    Time Frame
    12 weeks
    Title
    patient's visual analogue scale for disease activity
    Description
    patients self-reported judgement on a 100 mm scale
    Time Frame
    12 weeks
    Title
    short form 36 questionnaire (SF36)
    Description
    standardised patient reported outcome measurement (11categories regarding quality of life)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eugen Feist, MD
    Organizational Affiliation
    Charité Berlin, Department of rheumatology and clinical immunology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27538847
    Citation
    Zernicke J, Kedor C, Muller A, Burmester GR, Reisshauer A, Feist E. A prospective pilot study to evaluate an animated home-based physical exercise program as a treatment option for patients with rheumatoid arthritis. BMC Musculoskelet Disord. 2016 Aug 18;17(1):351. doi: 10.1186/s12891-016-1208-3.
    Results Reference
    derived

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

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