Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming

Study Overview
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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.

Official Title
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Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii) A Randomized Controlled Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Structured access to a Wii game computer (Wii)
* Behavioral: Motivational support only


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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<br>* The control group receives an protocolized exercise advice and telephone follow-up at 2, 4, 8 and 12 weeks<br>* Other names: MOS;|
| Experimental: Wii Group<br>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)<br>* 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<br>* Other names: Wii group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |