The Effect of Exercise Intervention on Cardiorespiratory Function and Exercise Capacity in Heart Failure Patients With Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Oxygen consumption (VO2)
研究概览
简要总结
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in diabetes mellitus with heart failure.
详细描述
This research intends to explore the effects of exercise training on the cardiopulmonary function and exercise tolerance of heart failure patients with diabetes mellitus. In addition to the impaired cardiac function, the clinical manifestations of patients with heart failure also shown the inefficiency of pulmonary function, peripheral vascular function, and musculoskeletal system. Due to low exercise tolerance, functional activities and quality of life are impaired. With the high hospitalization rate and high mortality rate, the clinical treatment of heart failure is challenging. At present, exercise has been listed in the guidelines for the treatment of heart failure, and is recommended that patients with heart failure should take regular aerobic exercise training to maintain functional activity and reduce symptoms. Past studies have also suggested that exercise training can help reduce the risk factors of cardiovascular disease and improve part of the cardiovascular function. Furthermore, exercise can improve the quality of life and reduce the hospitalization rate. Although diabetes is a common comorbidity of heart failure, and is a poor prognostic factor that increases the overall risk of heart failure and cardiovascular death, there are few studies in the past to further explore the benefits of exercise training for diabetes with heart failure, although current studies have confirmed that regular exercise can effectively control diabetes. However, the cardiopulmonary function and exercise tolerance of exercise training for diabetes with heart failure still need to be clarified. Therefore, this study aims to investigated the effect of cardiopulmonary function and exercise tolerance in patients with heart failure. The study participants were divided into two groups: usual care group and exercise group. Exercise training involved last for twelve weeks, and then follow up until the sixth week after exercise training. The results of the study are expected to be applied to clinical heart failure rehabilitation. It is expected that through active cardiopulmonary rehabilitation combined with precise and personalized exercise prescriptions, it will prevent deterioration of heart failure and may help improve the clinical practice of heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart Failure (NYHA I-III) with diabetes mellitus
- •Aged 30-85
- •Mini-mental state examination score > 25
排除标准
- •eGFR < 30mL/min/1.73m2
- •Exercise intervention contraindication of heart failure
- •Pregnancy
- •Uncontrolled disease
研究组 & 干预措施
Intervention group
The intervention group will receive multi-model exercise intervention 2-3 times per week for 3 months.
干预措施: Muti-model exercise intervention (Behavioral)
Usual care group
The Usual care group will receive heart failure disease and exercise-related education.
干预措施: Disease and exercise suggestion (Behavioral)
结局指标
主要结局
Oxygen consumption (VO2)
时间窗: Change from baseline (0 week) to follow up (24 weeks)
Oxygen consumption examined by cardiopulmonary exercise test
NT-proBNP
时间窗: Change from baseline (0 week) to follow up (24 weeks)
N-terminal pro-brain natriuretic peptide
NT-proBNP
时间窗: Change from baseline (0 week) to mid-intervention (6 weeks)
N-terminal pro-brain natriuretic peptide
NT-proBNP
时间窗: Change from baseline (0 week) to post-intervention (12 weeks)
N-terminal pro-brain natriuretic peptide
Oxygen consumption (VO2)
时间窗: Change from baseline (0 week) to mid-intervention (6 weeks)
Oxygen consumption examined by cardiopulmonary exercise test
Oxygen consumption (VO2)
时间窗: Change from baseline (0 week) to post-intervention (12 weeks)
Oxygen consumption examined by cardiopulmonary exercise test
次要结局
- Quality of life score (Minnesota Living With Heart Failure Questionnaire)(Change from baseline (0 week) to follow up (24 weeks))
- MEP (maximal exspiratory pressure)(Change from baseline (0 week) to follow up (24 weeks))
- FEV1/FVC(Change from baseline (0 week) to follow up (24 weeks))
- MIP (maximal inspiratory pressure)(Change from baseline (0 week) to follow up (24 weeks))
- Quality of life score (Minnesota Living With Heart Failure Questionnaire)(Change from baseline (0 week) to mid-intervention (6 weeks))
- Quality of life score (Minnesota Living With Heart Failure Questionnaire)(Change from baseline (0 week) to post-intervention (12 weeks))
- FEV1/FVC(Change from baseline (0 week) to mid-intervention (6 weeks))
- FEV1/FVC(Change from baseline (0 week) to post-intervention (12 weeks))
- MIP (maximal inspiratory pressure)(Change from baseline (0 week) to mid-intervention (6 weeks))
- MIP (maximal inspiratory pressure)(Change from baseline (0 week) to post-intervention (12 weeks))
- MEP (maximal exspiratory pressure)(Change from baseline (0 week) to mid-intervention (6 weeks))
- MEP (maximal exspiratory pressure)(Change from baseline (0 week) to post-intervention (12 weeks))
研究者
Kun-Ling Tsai
Associate Professor
National Cheng Kung University