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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
| The Swedish Heart and Lung Association | OTHER |
| Swedish Heart Lung Foundation | OTHER |
| Vardalinstitutet The Swedish Institute for Health Sciences |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle function | assessed with bilateral isometric shoulder abduction and unilateral isotonic shoulder flexion using predefined protocols | Baseline, 3, 6, 12 months |
| Exercise Motivation | assessed by the Exercise motivation Index (EMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Irvine | California | CA 92697 | United States | ||
| Center of Internal Medicine Elsterwerda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42419872 | Derived | 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. | |
| 39743240 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Medical Research Council of Southeast Sweden | OTHER_GOV |
| Swedish Council for Working Life and Social Research | OTHER |
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| Motivational support only | Behavioral | The control group receives an protocolized exercise advice and telephone follow-up at 2, 4, 8 and 12 weeks |
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| Baseline, 3, 6, 12 months |
| Daily Physical Activity | measured by an activity monitor | monitored every day during 6 months |
| Exercise Self-Efficacy | assessed by the exercise self-efficacy questionnaire (SEE) | Baseline, 3, 6, 12 months |
| Perceived Physical Effort | assessed with the Borg's scale of perceived exertion | Daily for the first 3 months |
| Heart Failure Symptoms | assessed using a 10 point VAS scale | Daily for the first 3 months |
| Health Related Quality of Life | assessed with Minnesota Living with Heart Failure Questionnaire(MLWHFQ) | Baseline, 3, 6, 12 months |
| Global Well-Being | assessed with Cantril's ladder of life | Daily for the first 3 months |
| Readmission | assessed from the medical record | 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 | 12 months |
| Experiences of patients | An open ended survey will be used to collect data on patient's experiences and challenges | 12 months |
| change in 6 minute walk | 6 and 12 monhts |
| Elsterwerda |
| Germany |
| Rabin Medical Center | Petah Tikva | Israel |
| Villa delle Querce hospital | Nemi | Italy |
| Maastricht University Medical Center | Maastricht | Netherlands |
| Länssjukhuset Ryhov hospital | Jönköping | Sweden |
| University hospital Linköping | Linköping | Sweden |
| Vrinnevi Hospital | Norrköping | Sweden |
| Nyköpings lasarett hospital | Nyköping | Sweden |
| Karolinska University Hospital Huddinge | Stockholm | Sweden |
| 36473172 | 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. |
| 32501275 | 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. |
| 32167657 | 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. |
| 26139585 | 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. |