Heart FailureNCT03538249
Effects of Rehabilitation in Patients With Stable Chronic Heart Failure
A study testing Aerobic training, Inspiratory muscle training and Resistance Training in people with Heart Failure and Aerobic Exercise, run by Lebanese University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Heart Failure, Aerobic Exercise, Quality of Life
- What is being tested?
- Aerobic training, Inspiratory muscle training and Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
About this study
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.
Read more
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.
Read the 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
- Conditions
- Heart Failure, Aerobic Exercise, Quality of Life, Respiratory Muscle Training, Strength Training, Exercise Intolerance
- Being tested
- Aerobic training, Inspiratory muscle training, Resistance Training, Aerobic and Inspiratory training, Combined
- Keywords
- Heart Failure, Aerobic Exercise, Respiratory Muscle Training, Strength Training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
Inspiratory muscle trainingOther
Also called Respiratory Training
Resistance TrainingOther
Also called Strength training
Aerobic and Inspiratory trainingOther
CombinedOther
Aerobic, inspiratory and resistance training
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training | Experimental | 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. Receives: Other: Aerobic training |
| Inspiratory muscle training | Experimental | 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. Receives: Other: Inspiratory muscle training |
| Resistance training | Experimental | 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. Receives: Other: Resistance Training |
| Control | No intervention | The control group patients were allocated to a non-training time period, during which they were told to continue their life as before enrollment. |
| Aerobic and Inspiratory training | Experimental | 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. Receives: Other: Aerobic and Inspiratory training |
| Combined | Experimental | 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. Receives: Other: Combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (12)
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
Change in Maximal Inspiratory Pressure (MIP)
MIP (cm h2o) was assessed to evaluate the strength of inspiratory muscles using Electronic pressure transducer.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study startJan 2015
- Primary completion15 Oct 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lebanese University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra SADEK, Lebanese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538249
- Sponsor's protocol ID
- 0H6BKP01G84
- Status last verified
- May 2018
- First submitted
- 20 Apr 2018
- Last updated
- 29 May 2018
- Results posted
- No
- Individual data sharing
- Undecided: no plan
Publications
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.
PubMed 32370544
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Characterization of Respiratory Muscles and Effects of Rehabilitation in Patients With Stable Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03538249
- Acronym / sponsor ID
- 0H6BKP01G84
- Conditions
- Heart Failure, Aerobic Exercise, Quality of Life, Respiratory Muscle Training, Strength Training, Exercise Intolerance
- Keywords
- Heart Failure, Aerobic Exercise, Respiratory Muscle Training, Strength Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lebanese UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic training | Experimental | Other: Aerobic trainingPatients 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 | Experimental | Other: Inspiratory muscle trainingThe 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 | Experimental | Other: Resistance TrainingThe 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. |
| Control | No intervention | –The control group patients were allocated to a non-training time period, during which they were told to continue their life as before enrollment. |
| Aerobic and Inspiratory training | Experimental | Other: Aerobic and Inspiratory trainingNote 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. |
| Combined | Experimental | Other: CombinedNote 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic training | Other | Aerobic training |
| Inspiratory muscle trainingAlso: Respiratory Training | Other | Inspiratory muscle training |
| Resistance TrainingAlso: Strength training | Other | Resistance training |
| Aerobic and Inspiratory training | Other | Aerobic and Inspiratory training |
| CombinedAerobic, inspiratory and resistance training | Other | Combined |
Primary outcome
Change in Minnesota Living with Heart Failure Questionnaire (MLWHF)
Time frame: 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.
12 secondary outcomes
Change in Forced Vital Capacity (FVC)
Time frame: Baseline and 12 weeks
Change in Forced Expiratory Muscle Volume in one second (FEV1)
Time frame: Baseline and 12 weeks
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline and 12 weeks
Change in Left Ventricular End Systolic and Diastolic Diameter (LVESD and LVEDD)
Time frame: Baseline and 12 weeks
Change in Maximal Inspiratory Pressure (MIP)
Time frame: Baseline and 12 weeks
Change in Sustained Maximal Inspiratory Pressure [SMIP]
Time frame: Baseline and 12 weeks
Change in Borg scale
Time frame: Baseline and 12 weeks
Change in six-minute walk test (6MWT)
Time frame: Baseline and 12 weeks
Change in Exercise time in stress test
Time frame: Baseline and 12 weeks
Change in Metabolic Equivalent of a Task (METs)
Time frame: Baseline and 12 weeks
Change in Maximal Voluntary Isometric Force (MVIF)
Time frame: Baseline and 12 weeks
Change in Isometric endurance time (MT)
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Derived from this study: PubMed 32370544Sadek 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.
- Individual participant dataSharing planned: Undecided. no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training, Inspiratory muscle training and Resistance Training in people with Heart Failure and Aerobic Exercise, run by Lebanese University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Minnesota Living with Heart Failure Questionnaire (MLWHF) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.