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Completed

NCT Number: NCT02658370

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

animated home-based exercises (Wii-fit)

Device

Other names: software Wii-fit plus

conventional home-based exercise program

Procedure

Primary outcomes

  1. feasibility of the animated home-based physical exercise program

    Time frame: 12 weeks

    to be assessed by qualitative interview analysis

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Eugen Feist

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 18, 2016
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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