Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming

NCT01785121 | Completed DMC

• 1 other identifier: HF-Wii
• Study Type: interventional
• Target: 605
• Locations: 6 countries
• Sites: 10

Brief Summary

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?

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• change in 6 minute walk test

  The 6 minute walk test measures the amount of meters covered by a patients in 6 minutes using a protocolled assessment

  3 months

Secondary Outcomes (12)

• Muscle function

  Baseline, 3, 6, 12 months

• Exercise Motivation

  Baseline, 3, 6, 12 months

• Daily Physical Activity

  monitored every day during 6 months

• Exercise Self-Efficacy

  Baseline, 3, 6, 12 months

• Perceived Physical Effort

  Daily for the first 3 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Motivational support only

Wii Group

EXPERIMENTAL

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

Behavioral: Structured access to a Wii game computer (Wii)

Interventions

Structured access to a Wii game computer (Wii) 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

Also known as: Wii group

Wii Group

Motivational support only BEHAVIORAL

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

Also known as: MOS

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead
• The Swedish Research Council: collaborator
• The Swedish Heart and Lung Association: collaborator
• Swedish Heart Lung Foundation: collaborator
• Vardalinstitutet The Swedish Institute for Health Sciences: collaborator
• Medical Research Council of Southeast Sweden: collaborator
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (10)

University of California

Irvine, California, CA 92697, United States

Location

Center of Internal Medicine Elsterwerda

Elsterwerda, Germany

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Villa delle Querce hospital

Nemi, Italy

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Länssjukhuset Ryhov hospital

Jönköping, Sweden

Location

University hospital Linköping

Linköping, Sweden

Location

Vrinnevi Hospital

Norrköping, Sweden

Location

Nyköpings lasarett hospital

Nyköping, Sweden

Location

Karolinska University Hospital Huddinge

Stockholm, Sweden

Location

Related Publications (5)

• 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.

  PMID: 39743240 DERIVED

• 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.

  PMID: 36473172 DERIVED

• 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.

  PMID: 32501275 DERIVED

• 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.

  PMID: 32167657 DERIVED

• 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.

  PMID: 26139585 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 7, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

IT (1); US (1); IL (1); DE (1); NL (1); SE (5)