Functional Characterization of Respiratory Muscles and Effects of Rehabilitation in Patients With Stable Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in Minnesota Living with Heart Failure Questionnaire (MLWHF)
研究概览
简要总结
Heart failure (HF) is a major public health problem. This is the first cause of hospitalization and mortality of about 65 years old. This syndrome is characterized by a poor prognosis and a high cost of care. Thus, new strategies for treatment and prevention of the HF are among the major challenges facing health sciences today.
The management of HF requires multimodal approach it involves a combination of non-pharmacological and pharmacological treatment, Besides improvements in pharmacological treatment, supervised exercise programs are recommended for all patients with HF as part of a non-pharmacological management but many questions regarding exercise training in HF patients remain unanswered. Even simple questions such as the best mode of training for these patients are unclear.
The aim of this study
- First, to characterize the physiological functions involved in the genesis of exercise intolerance and dyspnea especially muscle function (respiratory and skeletal), and cardiopulmonary patients suffering from chronic HF.
- Second, to study and compare the effects of different rehabilitation programs and prove the superiority of the combination of three training modalities program: aerobic training (AT), resistance training (RT) and inspiratory muscle training (IMT).
These modalities are:
Aerobic Training: It has been proven effective in improving muscle abnormalities on changing the ventricular remodeling, dyspnea, functional capacity, increasing the maximum performance and reducing hospitalization in subjects suffering HF.
Resistance Training: It has been proven effective in improving skeletal muscle metabolism and angiogenesis; increasing capillary density and blood flow to the active skeletal muscles, promoting the synthesis and release of nitric oxide, and decreasing oxidative stress.
Selective Inspiratory Muscle Training: It has been proven effective in improving the strength and endurance of the respiratory muscles and reduction of dyspnea during daily activities.
详细描述
The Heart failure is the major cause of mortality and morbidity especially in elderly subjects.
The main feature of heart failure is exercise intolerance, which is always associated with fatigue and dyspnea in exercises of low intensity. Harrigton et al in 1997 demonstrated the existence of a dysfunction of skeletal muscles. But it is likely that these changes are not limited to the musculature of the lower limbs but are widespread and may affected the respiratory muscles. Thus, this dysfunction of the respiratory and skeletal muscles associated with dyspnea can contribute to the genesis of fatigue and impaired physical performance in turn reducing the autonomy of individuals.
The guidelines recommend no pharmacologic strategies by specific exercises to relieve symptoms, improve exercise tolerance and quality of life and reduce the rate of hospitalization.
The supervised exercise programs are recommended for all patients who have CHF as part of a non-pharmacological management. Thus, the exercise remains the pioneer of cardiac rehabilitation programs. The effectiveness of the training of the skeletal muscles against resistance (RT) and aerobic training (AT) in the rehabilitation HF has been well documented. However, selective training of respiratory muscles (IMT) is a relatively new technique in the field of the ICC.
In 1995, Mancini et al. were the first to publish a report on the advantage of selective training of respiratory muscles in HF patients.
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 (Participant, Outcomes Assessor)
盲法说明
All evaluations were performed by investigators who were unaware of the allocation of patients to different interventions.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aerobic and Inspiratory training
Note that the Aerobic and Inspiratory group participant undergone same protocols of inspiratory and aerobic training stated above, with almost a 5 minutes rest in between.
干预措施: Aerobic and Inspiratory training (Other)
Aerobic training
Patients follow an alternating aerobic training using a treadmill at an intensity of 60% of maximum heart rate, 3 mn and 3 mn working off an alternative way.To ensure progressive overload appropriate, we adjust moderate intensity aerobic exercise every two weeks with an overall 5% increase in heart rate.
干预措施: Aerobic training (Other)
Inspiratory muscle training
The inspiratory muscle training involves a high intensity endurance training to 60% of PI, max. We recalculate the individual SPImax and PImax in each training session. Patients use the driving tool inspiratory muscle.
干预措施: Inspiratory muscle training (Other)
Resistance training
The resistance should be measured on 1 RM (Repetition Maximum) for each muscle group. The exercises are performed in three sets of ten repetitions of exercises at 60% of 1RM intensity recalculated every two weeks training.
干预措施: Resistance Training (Other)
Control
The control group patients were allocated to a non-training time period, during which they were told to continue their life as before enrollment.
Combined
Note that the Aerobic, Inspiratory and resistance group participant undergone same protocols of inspiratory and aerobic training stated above, with almost a 5 minutes rest in between.
干预措施: Combined (Other)
结局指标
主要结局
Change in Minnesota Living with Heart Failure Questionnaire (MLWHF)
时间窗: Baseline and 12 weeks
The Quality of life was assessed using the Minnesota Living with Heart Failure Questionnaire (MLWHF). the minimum score is 0 and the maximum score is 105. the total score should decrease to indicate the amelioration of the quality of life.
次要结局
- Change in Forced Vital Capacity (FVC)(Baseline and 12 weeks)
- Change in Forced Expiratory Muscle Volume in one second (FEV1)(Baseline and 12 weeks)
- Change in Left Ventricular Ejection Fraction (LVEF)(Baseline and 12 weeks)
- Change in Left Ventricular End Systolic and Diastolic Diameter (LVESD and LVEDD)(Baseline and 12 weeks)
- Change in Maximal Inspiratory Pressure (MIP)(Baseline and 12 weeks)
- Change in Sustained Maximal Inspiratory Pressure [SMIP](Baseline and 12 weeks)
- Change in Borg scale(Baseline and 12 weeks)
- Change in six-minute walk test (6MWT)(Baseline and 12 weeks)
- Change in Exercise time in stress test(Baseline and 12 weeks)
- Change in Metabolic Equivalent of a Task (METs)(Baseline and 12 weeks)
- Change in Maximal Voluntary Isometric Force (MVIF)(Baseline and 12 weeks)
- Change in Isometric endurance time (MT)(Baseline and 12 weeks)
研究者
Zahra SADEK
Head of Physical Therapy Center
Lebanese University