Heart-eXg Study: Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure: An International Multi-center, Randomized, Parallel-group Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 12
- 主要终点
- Sedentary time
研究概览
简要总结
The goal of this to determine the effect of tailored exergaming for inactive patients with heart failure to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life.
Participants will, on a background of standard guideline-directed medical therapy patients, be randomised to tailored activity advice (control) or the Heart-Exergame (Heart-eXg) intervention for a period of 3 months. Patients randomised to the Heart-eXg group will receive an exergame with feedback and tailoring to adapt the exergaming advice. Patients will also be able to play with a person in their own network.
详细描述
Rationale: Heart failure (HF) is an increasing global health concern with over 20 million patients worldwide. A decrease in sedentary time can have beneficial effects for a growing group of inactive patients with HF. The use of exergames (games to improve physical activity) is promising for people who are home bound and physically inactive. Such a gaming activity should be attractive, tailored to preferences and to capacity.
Objective: To determine the effect of tailored exergaming for inactive patients with HF to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life.
Study design: A pilot study and a multicentre, open-label 1:1 randomised clinical trial with 6 months follow-up.
Study population: Adult patients with symptomatic HF: n= 20 for the pilot study and n=600 for the main study
Intervention: On a background of standard guideline-directed medical therapy patients will be randomised to tailored activity advice (control) or the Heart-Exergame (Heart-eXg) intervention for a period of 3 months. Patients randomised to the Heart-eXg group will receive an exergame with feedback and tailoring to adapt the exergaming advice. Patients will also be able to play with a person in their own network.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
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 symptomatic HF (NYHA II-IV) as diagnosed by cardiologist, (independent of Ejection Fraction: Patients with a preserved ejection fraction (HFpEF), mid-range ejection fraction (HFmrREF) or reduced ejection fraction (HFrEF) can be included.
- •Clinically stable
- •Physically inactive
- •Older than 18 years, there is no upper age limit,
- •Speak/understand the language of the country where the study is taking place.
- •Wanting to use a smartphone for the study (if patients do not have a smartphone, they can borrow it from the study team for the duration of the study)
排除标准
- •Unable to use an exergame due to visual, hearing, cognitive impairment assessed by HF nurse or cardiologist.
- •Not being able to perform the 6-minute walk test.
- •Not being able or willing to wear an activity monitor.
- •Currently included in a rehabilitation program
- •Lack of willingness to play an exergame.
- •Co-morbidity that hinders benefitting for this form of exercise (history of stroke, severe cognitive dysfunction, or a life expectancy shorter than 6 months).
研究组 & 干预措施
Exergame group
Patients will be introduced to the exergame and the exergame will be installed following a protocol either by the patients themselves or an instructor of the study.
Patients will be advised to exergame daily based on their activity monitor reading at baseline and based on their current activity level and preferences.
During the 3 months of active intervention patients will receive feedback on their activity level and data will also be shared with the coach who will use it to adapt the gaming advice. A clear exergaming goal will be set together by patient and coach. In the first month, they will receive weekly feedback on their performance based on the readings from the activity monitor and the reading from the exergame. In the rest of the active study team the frequency of the contact with the coach will be personalized.
干预措施: Heart Farming (Other)
Control group
Patients will receive a protocol-based activity advice (one time) from the HF team (nurse, cardiologist and/or physiotherapist) that corresponds to the intervention group in terms of time and effort. Participants in the control group are encouraged to decrease their sedentary behaviour to the same extent as the intervention group, and if possible be physical active 30 minutes for 5 days a week.
结局指标
主要结局
Sedentary time
时间窗: 3 months
Sedentary time measured with activity monitor Actigraph
次要结局
- Clinical frailty(Baseline, 3 months and 6 months)
- Exercise Capacity(Baseline, 3 months and 6 months)
- Frailty(Baseline, 3 months and 6 months)
- Heart Failure specific Quality of Life(Baseline, 3 months and 6 months)
- General Quality of Life(Baseline, 3 months and 6 months)
- Sedentary time(6 months)
研究者
Tiny Jaarsma
Professor
Linkoeping University