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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

  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.

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:

  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

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 groups in NCT03538249
Study groupRoleWhat they receive
Aerobic trainingExperimentalPatients 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 trainingExperimentalThe 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 trainingExperimentalThe 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
ControlNo interventionThe 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 trainingExperimentalNote 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
CombinedExperimentalNote 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted29 May 2018
  2. Study startJan 2015
  3. Primary completion15 Oct 2017
  4. Study completionJan 2018

Resources

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)
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

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.

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