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Effects of Rehabilitation in Patients With Stable Chronic Heart Failure

Primary Purpose

Heart Failure, Aerobic Exercise, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic training
Inspiratory muscle training
Resistance Training
Aerobic and Inspiratory training
Combined
Sponsored by
Lebanese University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Heart Failure, Aerobic Exercise, Respiratory Muscle Training, Strength Training

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Congestive heart failure (CHF) due to ischemic or dilated cardiomyopathy.
  • Left ejection fraction ≤ 45%.
  • NYHA functional class II and III.
  • A patient with a diagnosis of CHF for six months including no admission to the hospital or change in medications over the previous 3 months.
  • IMW <70% of predicted

Exclusion criteria

  • Pulmonary limitation (forced expiratory volume in 1 s and/or vital capacity of less than 60% of predicted value).
  • History of significant cardiac arrhythmia.
  • History of myocardial infarction or cardiac surgery (6 months).
  • Orthopedic or neurologic disease.
  • Non echogenic, Unstable.
  • Poorly controlled blood pressure.
  • End-Stage HF (on the waiting list for transplantation or LVAD).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Experimental

    Experimental

    Arm Label

    Aerobic training

    Inspiratory muscle training

    Resistance training

    Control

    Aerobic and Inspiratory training

    Combined

    Arm Description

    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.

    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.

    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.

    The control group patients were allocated to a non-training time period, during which they were told to continue their life as before enrollment.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in Minnesota Living with Heart Failure Questionnaire (MLWHF)
    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.

    Secondary Outcome Measures

    Change in Forced Vital Capacity (FVC)
    FVC was assessed to evaluate the lung Function. FVC measurement shows the amount of air a person can forcefully and quickly exhale after taking a deep breath.
    Change in Forced Expiratory Muscle Volume in one second (FEV1)
    FEV1 was assessed to evaluate the lung Function. FEV1 measurement shows the amount of air a person can forcefully exhale in one second of the FVC test.
    Change in Left Ventricular Ejection Fraction (LVEF)
    LVED was assessed to evaluate the cardiac function by using echocardiography at rest. LVEF (%) : the total amount of blood in the left ventricle is pumped out with each heartbeat.
    Change in Left Ventricular End Systolic and Diastolic Diameter (LVESD and LVEDD)
    LVESD and LVEDD was assessed to evaluate the cardiac function by using echocardiography at rest. Evaluation of the Left Ventricule dimensions (mm) and wall thicknesses in end-systolic and end-diastolic.
    Change in Maximal Inspiratory Pressure (MIP)
    MIP (cm h2o) was assessed to evaluate the strength of inspiratory muscles using Electronic pressure transducer.
    Change in Sustained Maximal Inspiratory Pressure [SMIP]
    SMIP (Secondes) was used to assess the respiratory muscle endurance where the time was recorded in the period during which a patient can cover maintaining 70% MIP.
    Change in Borg scale
    The dyspnea was assessed using Borg Scale. the minimum score is 6 and the maximum score is 20. the total score should decrease to indicate the amelioration of the dyspnea.
    Change in six-minute walk test (6MWT)
    The Functional capacity was assessed by using 6MWT in meters. the distance should increase to indicate the amelioration of the functional capacity.
    Change in Exercise time in stress test
    Exercise time (secondes) was assessed using Stress test on a treadmill according to the Bruce protocol. the time should increase to indicate the amelioration of the aerobic capacity.
    Change in Metabolic Equivalent of a Task (METs)
    The assessment of workload is measured by METs during stress test. METs is a unit that estimates the amount of energy used by the body during physical activity, as compared to resting metabolism. The unit is standardized so it can apply to people of varying body weight and compare different activities.
    Change in Maximal Voluntary Isometric Force (MVIF)
    MVIF (Kg) was assessed to evaluate the function of skeletal muscles using Dynamometer; to assess the strength of the quadriceps muscle.
    Change in Isometric endurance time (MT)
    MT (secondes) was assessed to evaluate the endurance of the quadriceps muscle. MT was measured when subjects maintained an isometric contraction at 50% of the reported MVIF.

    Full Information

    First Posted
    April 20, 2018
    Last Updated
    May 15, 2018
    Sponsor
    Lebanese University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03538249
    Brief Title
    Effects of Rehabilitation in Patients With Stable Chronic Heart Failure
    Official Title
    Functional Characterization of Respiratory Muscles and Effects of Rehabilitation in Patients With Stable Chronic Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    October 15, 2017 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lebanese University

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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: 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. Furthermore, the authors compared three different modalities of exercising against a modality which affects so the quality of the study. 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, 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, It is not known until now what combination of exercises modalities is the most effective and more secure, and 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: Heart and lung function, Heart and lung structure, The function of skeletal and respiratory muscles, Functional capacity, Dyspnea, and quality of life. The main objectives of this project are defined: To characterize the physiological functions involved in the genesis of exercise intolerance and dyspnea. Comparative study of all therapeutic modalities with a control group and each other. To study muscle function: respiratory and skeletal in HF patients in different training groups. To study the muscular structures: respiratory and skeletal. To study the structure and heart function. See the influence of these three training modalities on functional capacity, dyspnea and quality of life. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Aerobic Exercise, Quality of Life, Respiratory Muscle Training, Strength Training, Exercise Intolerance, Cardiac Rehabilitation
    Keywords
    Heart Failure, Aerobic Exercise, Respiratory Muscle Training, Strength Training

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Interventions Aerobic exercise 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. 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. 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.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    All evaluations were performed by investigators who were unaware of the allocation of patients to different interventions.
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Aerobic training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Inspiratory muscle training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Resistance training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group patients were allocated to a non-training time period, during which they were told to continue their life as before enrollment.
    Arm Title
    Aerobic and Inspiratory training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Combined
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Aerobic training
    Intervention Type
    Other
    Intervention Name(s)
    Inspiratory muscle training
    Other Intervention Name(s)
    Respiratory Training
    Intervention Type
    Other
    Intervention Name(s)
    Resistance Training
    Other Intervention Name(s)
    Strength training
    Intervention Type
    Other
    Intervention Name(s)
    Aerobic and Inspiratory training
    Intervention Type
    Other
    Intervention Name(s)
    Combined
    Intervention Description
    Aerobic, inspiratory and resistance training
    Primary Outcome Measure Information:
    Title
    Change in Minnesota Living with Heart Failure Questionnaire (MLWHF)
    Description
    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.
    Time Frame
    Baseline and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Forced Vital Capacity (FVC)
    Description
    FVC was assessed to evaluate the lung Function. FVC measurement shows the amount of air a person can forcefully and quickly exhale after taking a deep breath.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in Forced Expiratory Muscle Volume in one second (FEV1)
    Description
    FEV1 was assessed to evaluate the lung Function. FEV1 measurement shows the amount of air a person can forcefully exhale in one second of the FVC test.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in Left Ventricular Ejection Fraction (LVEF)
    Description
    LVED was assessed to evaluate the cardiac function by using echocardiography at rest. LVEF (%) : the total amount of blood in the left ventricle is pumped out with each heartbeat.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in Left Ventricular End Systolic and Diastolic Diameter (LVESD and LVEDD)
    Description
    LVESD and LVEDD was assessed to evaluate the cardiac function by using echocardiography at rest. Evaluation of the Left Ventricule dimensions (mm) and wall thicknesses in end-systolic and end-diastolic.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in Maximal Inspiratory Pressure (MIP)
    Description
    MIP (cm h2o) was assessed to evaluate the strength of inspiratory muscles using Electronic pressure transducer.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in Sustained Maximal Inspiratory Pressure [SMIP]
    Description
    SMIP (Secondes) was used to assess the respiratory muscle endurance where the time was recorded in the period during which a patient can cover maintaining 70% MIP.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in Borg scale
    Description
    The dyspnea was assessed using Borg Scale. the minimum score is 6 and the maximum score is 20. the total score should decrease to indicate the amelioration of the dyspnea.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in six-minute walk test (6MWT)
    Description
    The Functional capacity was assessed by using 6MWT in meters. the distance should increase to indicate the amelioration of the functional capacity.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in Exercise time in stress test
    Description
    Exercise time (secondes) was assessed using Stress test on a treadmill according to the Bruce protocol. the time should increase to indicate the amelioration of the aerobic capacity.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in Metabolic Equivalent of a Task (METs)
    Description
    The assessment of workload is measured by METs during stress test. METs is a unit that estimates the amount of energy used by the body during physical activity, as compared to resting metabolism. The unit is standardized so it can apply to people of varying body weight and compare different activities.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in Maximal Voluntary Isometric Force (MVIF)
    Description
    MVIF (Kg) was assessed to evaluate the function of skeletal muscles using Dynamometer; to assess the strength of the quadriceps muscle.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in Isometric endurance time (MT)
    Description
    MT (secondes) was assessed to evaluate the endurance of the quadriceps muscle. MT was measured when subjects maintained an isometric contraction at 50% of the reported MVIF.
    Time Frame
    Baseline and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Congestive heart failure (CHF) due to ischemic or dilated cardiomyopathy. Left ejection fraction ≤ 45%. NYHA functional class II and III. A patient with a diagnosis of CHF for six months including no admission to the hospital or change in medications over the previous 3 months. IMW <70% of predicted Exclusion criteria Pulmonary limitation (forced expiratory volume in 1 s and/or vital capacity of less than 60% of predicted value). History of significant cardiac arrhythmia. History of myocardial infarction or cardiac surgery (6 months). Orthopedic or neurologic disease. Non echogenic, Unstable. Poorly controlled blood pressure. End-Stage HF (on the waiting list for transplantation or LVAD).

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    no plan
    Citations:
    PubMed Identifier
    32370544
    Citation
    Sadek Z, Salami A, Youness M, Awada C, Hamade M, Joumaa WH, Ramadan W, Ahmaidi S. A randomized controlled trial of high-intensity interval training and inspiratory muscle training for chronic heart failure patients with inspiratory muscle weakness. Chronic Illn. 2022 Mar;18(1):140-154. doi: 10.1177/1742395320920700. Epub 2020 May 5.
    Results Reference
    derived

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    Effects of Rehabilitation in Patients With Stable Chronic Heart Failure

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