Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii) A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 605
- 试验地点
- 11
- 主要终点
- change in 6 minute walk test
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Group
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.
干预措施: Motivational support only (Behavioral)
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
干预措施: Structured access to a Wii game computer (Wii) (Behavioral)
结局指标
主要结局
change in 6 minute walk test
时间窗: 3 months
The 6 minute walk test measures the amount of meters covered by a patients in 6 minutes using a protocolled assessment
次要结局
- Exercise Self-Efficacy(Baseline, 3, 6, 12 months)
- Heart Failure Symptoms(Daily for the first 3 months)
- Health Related Quality of Life(Baseline, 3, 6, 12 months)
- Global Well-Being(Daily for the first 3 months)
- Costs(12 months)
- Muscle function(Baseline, 3, 6, 12 months)
- Daily Physical Activity(monitored every day during 6 months)
- Exercise Motivation(Baseline, 3, 6, 12 months)
- Perceived Physical Effort(Daily for the first 3 months)
- Readmission(12 months)
- Experiences of patients(12 months)
- change in 6 minute walk(6 and 12 monhts)
研究者
Tiny Jaarsma
Professor
Linkoeping University