The Addition of High-intensity vs. Low-intensity Inspiratory Muscle Training to Combined Aerobic and Resistance Exercise in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Aerobic Capacity
研究概览
简要总结
It is well-known that muscle weakness and deconditioning play an important role in low exercise capacity of patients with HF. Interestingly, not only peripheral muscles are impaired, but also respiratory muscles. Studies have shown that patients with HF may have, in addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and structural impairments in diaphragm fibers. Moreover, exercise capacity and weakness of inspiratory muscles have been associated with low quality of life and poor prognosis, which make the addition of inspiratory muscle training (IMT) reasonable in cardiovascular rehabilitation.The specifications of the loads to be imposed during IMT is the main factor determining the outcome. Studies of IMT have highlighted the need for a fixed inspiratory workload during exercise. Thus, purpose of this report was to perform a randomized clinical trial of the effects of addition of high-intensity vs. low-intensity IMT to combined aerobic and resistance Exercise in patients with 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
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The target population consists of adults patients aged ≥ 18 years with heart failure and New York Heart Association (NYHA) class I-III.
排除标准
- •Unstable angina;
- •coronary revascularization;
- •Decompensated heart failure functional class IV (NYHA);
- •Recent transplant or hospitalization (6 months <);
- •Chronic Obstructive Pulmonary Disease;
- •Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases;
- •Recent myocardial infarction or cardiac surgery (less than 6 months);
- •Atrial Fibrillation.
研究组 & 干预措施
High-intensity IMT
High-intensity IMT + Aerobic/resistance exercise
IMT: Training loads will be adjusted weekly to the maximal inspiratory pressure (MIP). In the first 2 weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 30 sec, with 30-sec of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 10 min and 30 sec. From the third week the protocol will be of 2 min warm-up with intensity 30% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 60 sec, with 60-second of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 17 min.
Exercise: see group Combined aerobic/resistance exercise
干预措施: High-intensity IMT + Aerobic/resistance exercise (Other)
Low-intensity IMT
Low-intensity IMT + Aerobic/resistance exercise
IMT:Training loads will be also adjusted weekly to the maximal inspiratory pressure (MIP). In the first two weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will be held with 3 sets of 15 repetitions, with 40% of MIP, finishing the training with 20% of MIP for 2 minutes. From the third week the protocol will be of 2 minutes warm-up with intensity 30% of MIP. The training will be held with 3 sets of 15 repetitions, with 60% of MIP, finishing the training with 30% of MIP for 2 minutes.
Exercise: see group Combined aerobic/resistance exercise
干预措施: Low-intensity IMT + Aerobic/resistance exercise (Other)
Aerobic/resistance exercise
Sham IMT + Aerobic/resistance exercise
Aerobic session will consist of a 4-min of warm-up, 20 minutes of exercise, and 4 min of cool-down. Intensity will set by the formula: Training HR = (maximum HR - resting HR) × intensity % + resting HR. Patients will exercise using 30 seconds, high-intensity work phases 0.7% followed by 1-minute recovery bouts 0.5%. Resistance exercise will consist of dynamic lower and upper limb exercise. Upper limb exercises will include 3 sets of exercises for each muscle group performed with 10 repetitions each. Lower limb exercises will include 3 sets of exercises for each muscle group performed with 12 repetitions each. Resistance exercises will be performed at 12-MR.
干预措施: Sham IMT + Aerobic/resistance exercise (Other)
结局指标
主要结局
Aerobic Capacity
时间窗: 10 weeks
Six-minute walk test
Health-Related Quality of Life: MLHFQ
时间窗: 10 weeks
Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)
次要结局
- Disability(10 weeks)
- Respiratory muscle strength(10 weeks)
研究者
Mansueto Gomes Neto
Principal researcher
Federal University of Bahia