Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Changes in peak oxygen uptake (ml/kg/min)
研究概览
简要总结
Heart failure (HF) is a multisystemic disease leading to exercise intolerance and fatigue. Supervised physical training improves functional capacity, quality of life and reduces hospital admissions in HF patients. In this way, home physical training may be a good alternative to patients who, for any reason, cannot perform supervised training. Objective: To asses the effects of a home-based training program on functional capacity, sedentary lifestyle and quality of life of patients with chronic HF compared to supervised training.
详细描述
After agreement with the written informed consent, subjects with heart failure (left ventricle ejection fraction bellow or equal 40%) will be included in this study. They will be randomized in two groups: Home-based and Supervised exercise groups. The two groups will be submitted to a twelve-week combined exercise program of aerobic and peripheral muscle training. All volunteers will be assessed at baseline and after twelve weeks of intervention. Peripheric and respiratory muscle strength as well the 6MW analyses were assessed also at 4 and 8 weeks after baseline.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic heart failure (functional class from NYHA II and III),
- •Left ventricle ejection fraction bellow or equal to 40%
- •Clinical stability during the last three months
- •Medical release for physical training after cardiopulmonary test
排除标准
- •Uncontrolled arrhythmia
- •Pulmonary artery systolic pressure > 35 mmHg by the echo doppler cardiogram,
- •Peripheral oxygen saturation < 92% in resting condition
- •Respiratory infection in the previous 30 days to the enrollment into the study
- •Cognitive, neurological or orthopedic limitations
研究组 & 干预措施
Home-based exercise rehabilitation
Patients will be submitted to a 12-weeks training program, with walking at 60-70% of heart rate reserve monitored by a heart rate monitor (30 minutes/session for 5 days/week) and peripheral muscle training including upper and lower limbs (50% of the 1-maximum repetition test)
干预措施: Exercise rehabilitation (Other)
Supervised exercise rehabilitation
Patients will be submitted to a 12-weeks training program, with sessions (3 days/week) supervised by a physiotherapist, including cycling at 60-70% of heart rate reserve and peripheral muscle training of upper and lower limbs (50% of the 1-maximum repetition test)
干预措施: Exercise rehabilitation (Other)
结局指标
主要结局
Changes in peak oxygen uptake (ml/kg/min)
时间窗: Baseline and after 12 weeks of exercise programs
Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 12 weeks.
次要结局
- Changes in distance from the six minute walk test (6MW, m)(Baseline and after 4, 8 and 12 weeks of exercise programs)
- Incidence of cardiac events and arrhythmia(Baseline and after 12 weeks of exercise programs)
- Changes in respiratory muscle strength (cmH2O)(Baseline and after 4, 8 and 12 weeks of exercise programs)
- Changes in peripheral muscle strength (N) - Quadriceps mm(Baseline and after 4, 8 and 12 weeks of exercise program)
- Changes in peripheral muscle strength (kgf) - Hand grip(Baseline and after 4, 8 and 12 weeks of exercise programs)
- Changes in daily physical activity and sedentary lifestyle(Baseline and after 12 weeks of exercise programs)
- Changes in International Physical Activity Questionnaire (IPAQ)(Baseline and after 12 weeks of exercise programs)
- Changes in quality of life using SF-36(Baseline and after 12 weeks of exercise programs)
- Changes in quality of life using MLHF(Baseline and after 12 weeks of exercise programs)
- Changes in brain natriuretic peptide (BNP, pg/mL)(Baseline and after 12 weeks of exercise programs)
- Changes in heart rate variability (HRV)(Baseline and after 12 weeks of exercise programs)
- Changes in sleep quality(Baseline and after 12 weeks of exercise programs)
- Changes in daytime sleepiness(Baseline and after 12 weeks of exercise programs)
研究者
NAOMI KONDO NAKAGAWA NAOMI KONDO
Associate Professor of Medical School of Sao Paulo University
University of Sao Paulo