Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming
- Conditions
- Heart Failure
- Interventions
- Behavioral: Structured access to a Wii game computer (Wii)Behavioral: Motivational support only
- Registration Number
- NCT01785121
- Lead Sponsor
- Linkoeping University
- 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?
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 605
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wii Group 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 Control Group Motivational support only 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.
- Primary Outcome Measures
Name Time Method change in 6 minute walk test 3 months The 6 minute walk test measures the amount of meters covered by a patients in 6 minutes using a protocolled assessment
- Secondary Outcome Measures
Name Time Method Muscle function Baseline, 3, 6, 12 months assessed with bilateral isometric shoulder abduction and unilateral isotonic shoulder flexion using predefined protocols
Exercise Self-Efficacy Baseline, 3, 6, 12 months assessed by the exercise self-efficacy questionnaire (SEE)
Heart Failure Symptoms Daily for the first 3 months assessed using a 10 point VAS scale
Health Related Quality of Life Baseline, 3, 6, 12 months assessed with Minnesota Living with Heart Failure Questionnaire(MLWHFQ)
Global Well-Being Daily for the first 3 months assessed with Cantril's ladder of life
Costs 12 months 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
Daily Physical Activity monitored every day during 6 months measured by an activity monitor
Exercise Motivation Baseline, 3, 6, 12 months assessed by the Exercise motivation Index (EMI)
Perceived Physical Effort Daily for the first 3 months assessed with the Borg's scale of perceived exertion
Readmission 12 months assessed from the medical record
Experiences of patients 12 months An open ended survey will be used to collect data on patient's experiences and challenges
change in 6 minute walk 6 and 12 monhts
Trial Locations
- Locations (10)
Vrinnevi Hospital
🇸🇪Norrköping, Sweden
Länssjukhuset Ryhov hospital
🇸🇪Jönköping, Sweden
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Center of Internal Medicine Elsterwerda
🇩🇪Elsterwerda, Germany
University hospital Linköping
🇸🇪Linköping, Sweden
Villa delle Querce hospital
🇮🇹Nemi, Italy
Nyköpings lasarett hospital
🇸🇪Nyköping, Sweden
Karolinska University Hospital Huddinge
🇸🇪Stockholm, Sweden
University of California
🇺🇸Irvine, California, United States