Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming

NCT ID: NCT01785121

Last Updated: 2019-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

605 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-04-30

Brief Summary

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The study objectives are to determine the effectiveness of structured access to a Wii game computer compared to motivational support only in heart failure patients on exercise capacity and daily activity. Secondly, to determine the effectiveness of structured access to a Wii game computer compared to motivational support only in heart failure patients on the combined endpoint of death, readmission and quality of life.

The following research questions will be addressed:

* What is the effectiveness of structured introduction and access to a Wii game computer in patients with heart failure to improve their exercise capacity compared to patients with heart failure in a control group who only receive motivational support?
* What is the effectiveness of structured introduction and access to a Wii game computer in patients with heart failure compared to patients with heart failure in a control group who only receive motivational support to increase their daily physical activity, decrease health care use and improve quality of life?
* What are experiences of heart failure patients and how is their exercise motivation when they are introduced and instructed to play with a Wii game computer?

Detailed Description

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Substudy

HF-WII PLUS MEDIYOGA

In this substudy Medical Yoga will be tested in a randomized group next to the Wii and the control group in the HF-Wii study and therefore the substudy will be called HF-Wii plus MediYoga.

In addition to the usual treatment and information about rehabilitation and daily activities for heart failure patients, this group will train a 60-minute yoga class twice a week. Patients will sit on chairs or yoga mats to perform yoga. Each patient will perform a total of 20-24 sessions over a 12-weeks period. A session will include 10 min warm-up and breathing exercises, 40 minutes of yoga postures and finally 10 min relaxation and meditation. At the end of each session, participants have the opportunity to discuss their experiences or questions. At the first visit, participants will receive a CD and a booklet with yoga postures and instructions. Patients are encouraged to train Medi Yoga at home with a target of one session a day. All yoga sessions will be conducted by a certified Medicare Yoga instructor.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control Group

Patients who are randomized to the MSO group will get a protocoled exercise advice from a member of the HF team (nurse, cardiologist or physiotherapist). During the first three months after inclusion, patients will be phoned after 2, 4, 8, 12 weeks to discuss their current activity.

Group Type ACTIVE_COMPARATOR

Motivational support only

Intervention Type BEHAVIORAL

The control group receives an protocolized exercise advice and telephone follow-up at 2, 4, 8 and 12 weeks

Wii Group

Patients who are randomized to the Wii group will be introduced to the Nintendo Wii game computer in an introduction lesson of approximately two hours and the Wii will be installed at home. During the first three months after inclusion, patients will be phoned after 2, 4, 8, 12 weeks to discuss their experiences with the Wii or to solve possible problems

Group Type EXPERIMENTAL

Structured access to a Wii game computer (Wii)

Intervention Type BEHAVIORAL

Patients who are randomized to the Wii group will be introduced to the Nintendo Wii game computer in an introduction lesson of approximately two hours and the Wii will be installed at home. During the first three months after inclusion, patients will be phoned after 2, 4, 8, 12 weeks to discuss their experiences with the Wii or to solve possible problems

Interventions

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Structured access to a Wii game computer (Wii)

Patients who are randomized to the Wii group will be introduced to the Nintendo Wii game computer in an introduction lesson of approximately two hours and the Wii will be installed at home. During the first three months after inclusion, patients will be phoned after 2, 4, 8, 12 weeks to discuss their experiences with the Wii or to solve possible problems

Intervention Type BEHAVIORAL

Motivational support only

The control group receives an protocolized exercise advice and telephone follow-up at 2, 4, 8 and 12 weeks

Intervention Type BEHAVIORAL

Other Intervention Names

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Wii group MOS

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with HF (NYHA I-IV) (independent of Ejection Fraction: both patients with a preserved ejection fraction (HFPEF) or reduced ejection fraction (HFREF) can be included)
* Older than 18 years, there is no upper age limit
* Speak/understand the language of the country where the intervention is taken place

Exclusion Criteria

* The patient is expected to be unable to use the Nintendo Wii due to visual (see a TV screen at a distance of 3 m) cognitive (assessed by the HF nurse or cardiologist) or motor impairment (the patient should be able to swing his arm at least 10 times in a row)
* The patient has restrictions that would them unable patients to fill in data collection material
* The patient has a life expectancy shorter than 6 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

The Swedish Heart and Lung Association

OTHER

Sponsor Role collaborator

Swedish Heart Lung Foundation

OTHER

Sponsor Role collaborator

Vardalinstitutet The Swedish Institute for Health Sciences

OTHER

Sponsor Role collaborator

Medical Research Council of Southeast Sweden

OTHER_GOV

Sponsor Role collaborator

Swedish Council for Working Life and Social Research

OTHER

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tiny Jaarsma

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California

Irvine, California, United States

Site Status

Center of Internal Medicine Elsterwerda

Elsterwerda, , Germany

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Villa delle Querce hospital

Nemi, , Italy

Site Status

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Länssjukhuset Ryhov hospital

Jönköping, , Sweden

Site Status

University hospital Linköping

Linköping, , Sweden

Site Status

Vrinnevi Hospital

Norrköping, , Sweden

Site Status

Nyköpings lasarett hospital

Nyköping, , Sweden

Site Status

Karolinska University Hospital Huddinge

Stockholm, , Sweden

Site Status

Countries

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United States Germany Israel Italy Netherlands Sweden

References

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Klompstra L, Hagglund E, Jaarsma T, Kato NP, Stromberg A. Effects of exergaming and yoga on exercise capacity and physical and mental health in heart failure patients: a randomized sub-study. Eur J Cardiovasc Nurs. 2025 Apr 11;24(3):389-398. doi: 10.1093/eurjcn/zvae155.

Reference Type DERIVED
PMID: 39743240 (View on PubMed)

Klompstra L, Mourad G, Jaarsma T, Stromberg A, Alwin J. Costs of an Off-the-Shelf Exergame Intervention in Patients with Heart Failure. Games Health J. 2023 Jun;12(3):242-248. doi: 10.1089/g4h.2022.0013. Epub 2022 Dec 5.

Reference Type DERIVED
PMID: 36473172 (View on PubMed)

Poli A, Kelfve S, Klompstra L, Stromberg A, Jaarsma T, Motel-Klingebiel A. Prediction of (Non)Participation of Older People in Digital Health Research: Exergame Intervention Study. J Med Internet Res. 2020 Jun 5;22(6):e17884. doi: 10.2196/17884.

Reference Type DERIVED
PMID: 32501275 (View on PubMed)

Jaarsma T, Klompstra L, Ben Gal T, Ben Avraham B, Boyne J, Back M, Chiala O, Dickstein K, Evangelista L, Hagenow A, Hoes AW, Hagglund E, Piepoli MF, Vellone E, Zuithoff NPA, Martensson J, Stromberg A. Effects of exergaming on exercise capacity in patients with heart failure: results of an international multicentre randomized controlled trial. Eur J Heart Fail. 2021 Jan;23(1):114-124. doi: 10.1002/ejhf.1754. Epub 2020 Mar 13.

Reference Type DERIVED
PMID: 32167657 (View on PubMed)

Jaarsma T, Klompstra L, Ben Gal T, Boyne J, Vellone E, Back M, Dickstein K, Fridlund B, Hoes A, Piepoli MF, Chiala O, Martensson J, Stromberg A. Increasing exercise capacity and quality of life of patients with heart failure through Wii gaming: the rationale, design and methodology of the HF-Wii study; a multicentre randomized controlled trial. Eur J Heart Fail. 2015 Jul;17(7):743-8. doi: 10.1002/ejhf.305.

Reference Type DERIVED
PMID: 26139585 (View on PubMed)

Other Identifiers

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HF-Wii

Identifier Type: -

Identifier Source: org_study_id

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