Rheumatoid ArthritisNCT02658370
An Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis
A study testing animated home-based exercises (Wii-fit) and conventional home-based exercise program in people with Rheumatoid Arthritis, run by Eugen Feist.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- animated home-based exercises (Wii-fit) and conventional home-based exercise program
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Epilepsy
- Flare of RA
- A previous use of a Wii console for more than 5 hours
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- animated home-based exercises (Wii-fit), conventional home-based exercise program
- Keywords
- physical exercises, physical therapy, Wii game console, patients perspective
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
animated home-based exercises (Wii-fit)Device
Also called software Wii-fit plus
conventional home-based exercise programProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| animated home-based exercises (Wii-fit) | Experimental | using the Wii game console by Nintendo Receives: 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 Receives: Device: animated home-based exercises (Wii-fit); Procedure: conventional home-based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of the animated home-based physical exercise program
to be assessed by qualitative interview analysis
Measured: 12 weeks
Secondary outcomes (7)
muscle strenght measurement
isometric measurement of 9 muscle groups by using a handheld dynamometer
Measured: 12 weeks
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.
Measured: 12 weeks
respiratory function test
peak expiratory flow taken by a peak flow meter (liter/ Minute)
Measured: 12 weeks
Health Assessment Questionnaire Disability Indes (HAQ-DI)
standardised Patient reported outcome measurement (8 categories regarding disabilities in daily life)
Measured: 12 weeks
patient's visual analogue scale for pain
patients self-reported judgement on a 100 mm scale
Measured: 12 weeks
patient's visual analogue scale for disease activity
patients self-reported judgement on a 100 mm scale
Measured: 12 weeks
short form 36 questionnaire (SF36)
standardised patient reported outcome measurement (11categories regarding quality of life)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startAug 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eugen Feist
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eugen Feist, Charite University, Berlin, Germany
- Investigators
- Eugen Feist, MD, Principal investigator, Charité Berlin, Department of rheumatology and clinical immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658370
- Sponsor's protocol ID
- EA1/189/10
- Status last verified
- Jan 2016
- First submitted
- 13 Jan 2016
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27538847
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study to Evaluate an Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02658370
- Acronym / sponsor ID
- EA1/189/10
- Conditions
- Rheumatoid Arthritis
- Keywords
- physical exercises, physical therapy, Wii game console, patients perspective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eugen FeistUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| animated home-based exercises (Wii-fit) | Experimental | Device: animated home-based exercises (Wii-fit), Procedure: conventional home-based exercise programusing the Wii game console by Nintendo |
| conventional home-based exercise program | Active comparator | Device: animated home-based exercises (Wii-fit), Procedure: conventional home-based exercise programby using a compilation with 31 exercises especially for rheumatoid arthritis patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Epilepsy
- Flare of RA
- A previous use of a Wii console for more than 5 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| animated home-based exercises (Wii-fit)Also: software Wii-fit plus | Device | animated home-based exercises (Wii-fit), conventional home-based exercise program |
| conventional home-based exercise program | Procedure or surgery | animated home-based exercises (Wii-fit), conventional home-based exercise program |
Primary outcome
feasibility of the animated home-based physical exercise program
Time frame: 12 weeks
to be assessed by qualitative interview analysis
7 secondary outcomes
muscle strenght measurement
Time frame: 12 weeks
6-minute walk test
Time frame: 12 weeks
respiratory function test
Time frame: 12 weeks
Health Assessment Questionnaire Disability Indes (HAQ-DI)
Time frame: 12 weeks
patient's visual analogue scale for pain
Time frame: 12 weeks
patient's visual analogue scale for disease activity
Time frame: 12 weeks
short form 36 questionnaire (SF36)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Derived from this study: PubMed 27538847Zernicke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugen Feist, MD principal investigator
Charité Berlin, Department of rheumatology and clinical immunology
Questions about this trial
What is this clinical trial studying?
A study testing animated home-based exercises (Wii-fit) and conventional home-based exercise program in people with Rheumatoid Arthritis, run by Eugen Feist.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of the animated home-based physical exercise program (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02658370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.