Heart FailureHF-WiiNCT01785121
Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming
A study testing Structured access to a Wii game computer (Wii) and Motivational support only in people with Heart Failure, run by Linkoeping University at 10 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Structured access to a Wii game computer (Wii) and Motivational support only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Sep 2013to Apr 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Sweden5 sites
Länssjukhuset Ryhov hospital
Jönköping
University hospital Linköping
Linköping
Vrinnevi Hospital
Norrköping
Nyköpings lasarett hospital
Nyköping
Karolinska University Hospital Huddinge
Stockholm
United States1 site
University of California
Irvine, California, CA 92697
About this study
Official title: Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii) A Randomized Controlled Trial
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?
Read the detailed description
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
- Heart Failure
- Being tested
- Structured access to a Wii game computer (Wii), Motivational support only
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured access to a Wii game computer (Wii)Behavioural
Also called 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
Motivational support onlyBehavioural
Also called MOS
The control group receives an protocolized exercise advice and telephone follow-up at 2, 4, 8 and 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Structured access to a Wii game computer (Wii) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (12)
Muscle function
assessed with bilateral isometric shoulder abduction and unilateral isotonic shoulder flexion using predefined protocols
Measured: Baseline, 3, 6, 12 months
Exercise Motivation
assessed by the Exercise motivation Index (EMI)
Measured: Baseline, 3, 6, 12 months
Daily Physical Activity
measured by an activity monitor
Measured: monitored every day during 6 months
Exercise Self-Efficacy
assessed by the exercise self-efficacy questionnaire (SEE)
Measured: Baseline, 3, 6, 12 months
Perceived Physical Effort
assessed with the Borg's scale of perceived exertion
Measured: Daily for the first 3 months
Heart Failure Symptoms
assessed using a 10 point VAS scale
Measured: Daily for the first 3 months
Health Related Quality of Life
assessed with Minnesota Living with Heart Failure Questionnaire(MLWHFQ)
Measured: Baseline, 3, 6, 12 months
Global Well-Being
assessed with Cantril's ladder of life
Measured: Daily for the first 3 months
Readmission
assessed from the medical record
Measured: 12 months
Costs
cost of readmission, bed days occupancy (all cause) in medical/surgical beds, home care, contacts with and interventions of primary care, cost of the intervention (Wii game computer, instruction session etc.) and developing the intervention, materials and laboratory tests used
Measured: 12 months
Experiences of patients
An open ended survey will be used to collect data on patient's experiences and challenges
Measured: 12 months
change in 6 minute walk
Measured: 6 and 12 monhts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- The Swedish Research Council, The Swedish Heart and Lung Association, Swedish Heart Lung Foundation, Vardalinstitutet The Swedish Institute for Health Sciences, Medical Research Council of Southeast Sweden, Swedish Council for Working Life and Social Research
- Responsible party
- Principal investigator, Tiny Jaarsma, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785121
- Sponsor's protocol ID
- HF-Wii
- Acronym
- HF-Wii
- Status last verified
- Apr 2019
- First submitted
- 1 Feb 2013
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Papageorgiou JM, Jaarsma T, Hedman K, Karlsson N, Verheijden Klompstra L, Stromberg A. Prognostic value of baseline and longitudinal changes in exercise capacity and quality of life in the HF-Wii Swedish population. Open Heart. 2026 Jul 8;13(2):e004130. doi: 10.1136/openhrt-2026-004130.
PubMed 42419872Klompstra 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.
PubMed 39743240Klompstra 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.
PubMed 36473172Poli 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.
PubMed 32501275Jaarsma 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.
PubMed 32167657Jaarsma 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.
PubMed 26139585
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii) A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01785121
- Acronym / sponsor ID
- HF-Wii / HF-Wii
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- The Swedish Research Council, The Swedish Heart and Lung Association, Swedish Heart Lung Foundation, Vardalinstitutet The Swedish Institute for Health Sciences, Medical Research Council of Southeast Sweden, Swedish Council for Working Life and Social Research
- Study start
- Sep 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 7 Feb 2013 (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 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Motivational support onlyPatients 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. |
| Wii Group | Experimental | Behavioral: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Structured access to a Wii game computer (Wii)Also: Wii groupPatients 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 | Behavioural | Wii Group |
| Motivational support onlyAlso: MOSThe control group receives an protocolized exercise advice and telephone follow-up at 2, 4, 8 and 12 weeks | Behavioural | Control Group |
Primary outcome
change in 6 minute walk test
Time frame: 3 months
The 6 minute walk test measures the amount of meters covered by a patients in 6 minutes using a protocolled assessment
12 secondary outcomes
Muscle function
Time frame: Baseline, 3, 6, 12 months
Exercise Motivation
Time frame: Baseline, 3, 6, 12 months
Daily Physical Activity
Time frame: monitored every day during 6 months
Exercise Self-Efficacy
Time frame: Baseline, 3, 6, 12 months
Perceived Physical Effort
Time frame: Daily for the first 3 months
Heart Failure Symptoms
Time frame: Daily for the first 3 months
Health Related Quality of Life
Time frame: Baseline, 3, 6, 12 months
Global Well-Being
Time frame: Daily for the first 3 months
Readmission
Time frame: 12 months
Costs
Time frame: 12 months
Experiences of patients
Time frame: 12 months
change in 6 minute walk
Time frame: 6 and 12 monhts
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 3 Apr 2019.
- Derived from this study: PubMed 42419872Papageorgiou JM, Jaarsma T, Hedman K, Karlsson N, Verheijden Klompstra L, Stromberg A. Prognostic value of baseline and longitudinal changes in exercise capacity and quality of life in the HF-Wii Swedish population. Open Heart. 2026 Jul 8;13(2):e004130. doi: 10.1136/openhrt-2026-004130.
- Derived from this study: PubMed 39743240Klompstra 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.
- Derived from this study: PubMed 36473172Klompstra 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.
- Derived from this study: PubMed 32501275Poli 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.
- Derived from this study: PubMed 32167657Jaarsma 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.
- Derived from this study: PubMed 26139585Jaarsma 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured access to a Wii game computer (Wii) and Motivational support only in people with Heart Failure, run by Linkoeping University at 10 sites in 6 countries.
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 3 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Sweden, United States, Germany, Israel, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
change in 6 minute walk test (time frame: 3 months). 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 NCT01785121, which also lists 6 linked publications.
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 3 Apr 2019.