Heart Failure Clinical Trial
Official title:
Functional Characterization of Respiratory Muscles and Effects of Rehabilitation in Patients With Stable Chronic Heart Failure
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
1. 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.
2. 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.
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.
Another study showed the superiority of a high-intensity training, 60% of maximal inspiratory
pressure (PI max) on another 15% of PImax by increasing muscle strength and inspiratory
muscle endurance, improved exercise capacity, reduction of dyspnea and quality of life.
While the above studies have investigated the benefits of inspiratory muscle training alone
in CF patients, the question to ask is "If the benefit of the inspiratory muscle training was
added to that observed with aerobic training for the whole body. "
Laoutaris in 2013 showed that the combination of AT with RT and IMT could result in a
significant improvement in peripheral muscle and respiratory function with significant
improvement in exercise capacity, dyspnea and quality of life compared to that of the 'single
AT. However, this study has several limitations. These limits are:
1. Patients in the combined group suffer longer exercise sessions of 20 minutes compared to
patients alone aerobic group. Thus, the difference in the time to exercise between the 2
groups may have influenced the results of the study.
2. Furthermore, the authors compared three different modalities of exercising against a
modality which affects so the quality of the study.
3. In addition, the extent to which the resistance training or selective training of
respiratory muscles contributed to greater improvements in the combined group was not
assessed in this study as this would take several modalities groups different exercises
and a control group.
Till now,
1. There are no randomized, controlled, double blinding studies that compares different
modalities of exercises to each other and to a control group in patients who have CHF.
Moreover,
2. It is not known until now what combination of exercises modalities is the most effective
and more secure, and
3. If there are additional benefits by combining multiple training modalities by comparing
it with other modalities in patients with stable chronic heart failure (CHF).
In this study, the investigators examined the hypothesis of the efficiency of a combined
program of three modalities: aerobics, resistance, and selective respiratory muscle on:
1. Heart and lung function,
2. Heart and lung structure,
3. The function of skeletal and respiratory muscles,
4. Functional capacity,
5. Dyspnea, and quality of life.
The main objectives of this project are defined:
1. To characterize the physiological functions involved in the genesis of exercise
intolerance and dyspnea.
2. Comparative study of all therapeutic modalities with a control group and each other.
3. To study muscle function: respiratory and skeletal in HF patients in different training
groups.
4. To study the muscular structures: respiratory and skeletal.
5. To study the structure and heart function.
6. See the influence of these three training modalities on functional capacity, dyspnea and
quality of life.
7. To state the guidelines for heart failure.
Methodology and research requirements Protocol All subjects must sign an informed consent
form. Patients will submit a physical examination, and electrocardiographic measurements by a
cardiologist. Approximately 60 patients are divided randomly by investigators who are not
involved in the implementation of the project to eight different groups.
Before and after the intervention were evaluated all the tests mentioned above by a
physiotherapist who do not know the distribution of patients to different interventions.
Groups All types of training sessions are individualized and are carried in Beirut Cardiac
Institute. Patients are exerted for twelve weeks at a rate of three times per week, for one
hour. Any missed session will be added to the end of the program, so that the 36 sessions
will be realized. All sessions must be supervised at all times by a physiotherapist and a
cardiologist.
Group 1 (n = 10): Aerobic training (30mn) Group 2 (n = 10): Inspiratory muscle training
(20mn) Group 3 (n = 10): Resistance Training (20mn) Group 4 (n = 10): Aerobic Training (30
min) + Inspiratory muscle training (20mn) Group 5 (n = 10): Aerobic Training (30 min) +
Inspiratory muscle training (20minutes) + Resistance training (20 minutes) Group 6 (n = 10)
Control
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|