Clinical Study Protocol on the Impact of Community-Based Exercise Training on the Exercise Capacity of Patients With Reduced Cardiovascular and Pulmonary Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- exercise capacity
研究概览
简要总结
The goal of this clinical trial is to learn if community-based exercise training can benefit patients aged 18 to 85 with diminished cardiovascular and pulmonary function. The main aim of this study is:
• Establish a community or home-based fitness training program for patients with cardiopulmonary insufficiency to improve adherence, safety, and efficacy while alleviating the burden on both patients and society.
Researchers will compare community-based exercise training to non-exercise training to see if community-based exercise training works to improve cardiovascular and pulmonary function.
Participants will:
- Engage in community or home exercise training for 40-60 minutes, five times weekly, during a duration of eight weeks. Exercise modalities are primarily determined by the patients' individual preferences and habits, such as brisk walking, running, swimming, cycling, and hiking.
- Adjust the exercise intensity according to their cardiopulmonary exercise test and the person's perceived exertion level.
- Utilize fitness bracelets or watches to document statistics during workouts and submit them to the experimenter weekly, covering the five days of exercise within that week.
- refrain from making any dietary modifications throughout the trial.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 85 with abnormal pulmonary or cardiovascular function.
- •Individuals who have completed a medical screening form to confirm they are free from illnesses and prescription medications that could impair their ability to complete the required testing and fitness training.
- •Participants who did not engage in structured, systematic moderate-to-intense strength or endurance training during the study period (specifically, not within the previous year).
- •At the onset of the trial, participants were physically active but had never participated in formal exercise more than twice a week.
排除标准
- •Patients with neuromuscular or skeletal disorders, or systemic diseases such as diabetes, cancer, or heart disease.
- •Individuals using medications known to affect health or the interpretation of study results.
- •Participants who have engaged in organized, systematic endurance or strength training of moderate to high intensity within the past year.
- •Patients who decline to participate in the study.
- •Other medical conditions or states that render exercise training inappropriate.
研究组 & 干预措施
community-based exercise group
non-exercise group
结局指标
主要结局
exercise capacity
时间窗: at enrollment and week 8
Peak oxygen uptake (peakVO₂, ml/(kg·min)), measured by cardiopulmonary exercise testing (CPET), refers to the maximum rate of oxygen consumption per unit time during exhaustive incremental exercise. It serves as a key indicator of cardiopulmonary function and aerobic metabolic capacity.
life quality
时间窗: at enrollment and week 8
The Short Form-36 Health Survey (SF-36) was administered, with scores ranging from 0 to 100 across its eight subscales. Higher scores reflect superior health-related quality of life (HRQoL).
次要结局
- Other exercise capacity outcome(at enrollment and week 8)
- Blood indices(at enrollment and week 8)
- Leg strength(at enrollment and week 8)
- cardiac function(at enrollment and week 8)