NCT02658370

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

2.9 years

First QC Date

January 13, 2016

Last Update Submit

January 15, 2016

Conditions

Rheumatoid Arthritis

Keywords

physical exercisesphysical therapyWii game consolepatients perspective

Outcome Measures

Primary Outcomes (1)

  • feasibility of the animated home-based physical exercise program

    to be assessed by qualitative interview analysis

    12 weeks

Secondary Outcomes (7)

  • muscle strenght measurement

    12 weeks

  • 6-minute walk test

    12 weeks

  • respiratory function test

    12 weeks

  • Health Assessment Questionnaire Disability Indes (HAQ-DI)

    12 weeks

  • patient's visual analogue scale for pain

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

animated home-based exercises (Wii-fit)

EXPERIMENTAL

using the Wii game console by Nintendo

Device: animated home-based exercises (Wii-fit)Procedure: conventional home-based exercise program

conventional home-based exercise program

ACTIVE COMPARATOR

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

Device: animated home-based exercises (Wii-fit)Procedure: conventional home-based exercise program

Interventions

animated home-based exercises (Wii-fit)DEVICE
Also known as: software Wii-fit plus
animated home-based exercises (Wii-fit)conventional home-based exercise program
conventional home-based exercise programPROCEDURE
animated home-based exercises (Wii-fit)conventional home-based exercise program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Epilepsy
  • Flare of RA
  • A previous use of a Wii console for more than 5 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27538847DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Eugen Feist, MD

    Charité Berlin, Department of rheumatology and clinical immunology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 18, 2016

Study Start

August 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

January 18, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share