Heart FailureAEROFIT-HFNCT03726905
Complex Exercises of the Respiratory Muscles Plus Aerobic Training vs. Aerobic Training in Patients With СHF
A study testing respiratory muscles training and aerobic training in people with Heart Failure, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.
Trial summary
The aim of the study is to test the hypothesis that the physical rehabilitation starting with respiratory training followed by the aerobic exercises will have a more pronounced effect on clinical and functional indicators than the currently used physical rehabilitation based on aerobic training alone Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- respiratory muscles training and aerobic training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 30 Nov 2018to 30 Dec 2020
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 years and older (inclusive)
- Patients with stable heart failure of the II-III functional class.
- Signed patient informed consent to participate in the study.
- Left ventricular ejection fraction ≤40%, confirmed by the results of EchoCG no more than 3 months before the start of the study.
- Patients who can understand the objectives of this study and comply with the requirements of the Protocol.
Who cannot join
- • Heart failure I and VI functional class
- Left ventricular ejection fraction> 41% or no confirmed data on the left ventricular EF.
- Myocardial infarction, ACS, heart surgery, percutaneous coronary intervention, or coronary artery bypass surgery performed less than 3 months prior to randomization.
- Unstable or refractory angina.
- Pulmonary heart.
- Constrictive pericarditis.
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- Hypertrophic cardiomyopathy.
- Amyloid cardiomyopathy.
- Syndrome of premature excitation of the ventricles.
- The need for percutaneous coronary intervention or coronary bypass surgery in the near future.
- Sinus node dysfunction syndrome.
- The presence of a pacemaker.
- The presence of diagnosed non-cardiac causes of CHF.
- Any non-cardiac disease that reduces the expected duration to less than 2 years from the moment of randomization.
- A stroke less than 1 month prior to randomization or a stroke with marked continuing neurological disorders less than 12 months before randomization
- Orthopedic disorders that prevent physical training
- COPD, Bronchial asthma. Another lung disease that can affect CSTP results
- Significant impaired renal function (plasma creatinine 220 µmol / L or higher).
- Significant abnormal liver function (increased ALT or AST more than 3 times relative to the upper limit of normal).
- Acute coronary syndrome less than 3 months before randomization.
- Obstructive or restrictive cardiomyopathy.
- Acute myocarditis.
- Hemodynamically significant organic lesions of valves requiring surgical intervention.
- A history of heart transplantation or current waiting for a heart transplant.
- Drug addiction, substance abuse, alcoholism, drug use in history.
- Mental, physical and other reasons that do not allow to adequately assess their behavior and correctly fulfill the conditions of the study protocol.
- A history of any significant, in the opinion of the physician-researcher, condition / disease or circumstances that prevent the inclusion in the study.
- Inability / reluctance of the patient to provide signed informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Complex Exercises of the Respiratory Muscles Plus Aerobic Training vs. Aerobic Training in Patients With CHF and II-IV NYHA FC: Prospective Randomized Clinical Trial With Sham Control
The aim of the study is to test the hypothesis that the physical rehabilitation starting with respiratory training followed by the aerobic exercises will have a more pronounced effect on clinical and functional indicators than the currently used physical rehabilitation based on aerobic training alone
Read the detailed description
Changes in the respiratory muscles play an important role in the pathophysiology of exercise intolerance in CHF patients. The weakness of the respiratory muscles leads to a decrease in the efficiency of breathing and the formation of a pathological type of breathing, in which the inhalation time is prolonged, and the expiration time is shortened. Patients with weak respiratory muscles have impaired functional status, as determined by peak oxygen consumption. The violation of the ratio of inspiratory time / to the total time of the respiratory cycle is associated with an increase in the activity of the sympathoadrenal system. The positive effect of respiratory muscle training on MIP, MEP, peak VО 2, VE, VE / VCO 2 slope, VE oscillation, rhythm variability, and quality of life parameters is shown. Decreased oxygenation of the respiratory muscles during intense physical exertion in patients with CHF may increase respiratory failure and provoke hyperactivation of the inspiratory metaboreflex, thereby aggravating exercise intolerance due to a decrease in muscular-muscular system perfusion due to redistribution of blood flow. In addition, it was shown that fatigue of the respiratory muscles increases the activity of the sympathetic nervous system and reduces blood flow in the muscles of the inactive limb due to adrenergic vasoconstriction. This response is most likely associated with metabolic stimulation of small afferent type III and IV fibers of the respiratory muscles, especially the diaphragm. Respiratory muscle training can minimize the effects of inspiration metaboreflex activation and prolong the duration of exercise. In addition, several studies have shown that the strength of the respiratory muscles in patients with HF correlates with central hemodynamic indices at rest, including cardiac output, mean pulmonary pressure and pulmonary vascular resistance. Several studies have shown that the mechanism that improves exercise tolerance in patients with HF after training the respiratory muscles is to increase the blood supply to the muscles of the limbs at rest and during exercise. Thus, the mechanisms of the effect of the weakness of the respiratory muscles on the pathogenesis of a decrease in the functional ability of patients are well studied. Both respiratory muscular and aerobic exercises of moderate effectiveness are recommended by leading medical communities as an effective means to improve the functional ability of patients, improve quality of life parameters, improve symptoms and reduce hospital admissions (level of evidence Level 1). At the same time, respiratory muscle training is recommended as the beginning of physical rehabilitation in patients with IV FC HF, and moderate-intensity aerobic training is recommended for patients with FC I-III FC. Also, in individual works abroad, the effects of respiratory muscle training on clinical CHF. However, according to the investigator's information, no studies have been carried out on the study of the method of functional training, including training of the respiratory muscles, as an obligatory initial stage of physical rehabilitation of patients with any functional class of HF.
- Conditions
- Heart Failure
- Being tested
- respiratory muscles training, sham respiratory muscles training, aerobic training
- Keywords
- CHF, exercise, aerobic, respiratory muscle training
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory muscles trainingOther
4 weeks respiratory muscles training aimed on respiratory muscles endurance and lengthening expiration time
sham respiratory muscles trainingOther
4 weeks sham respiratory muscles training with the help of breathing simulators, with a breathing resistance level set at 0
aerobic trainingOther
12 weeks treadmill walking
| Study group | Role | What they receive |
|---|---|---|
| respiratory muscles training | Experimental | 4 weeks guided respiratory muscles training followed by 12 weeks guided aerobic training - (treadmill walking) Receives: Other: respiratory muscles training; Other: aerobic training |
| sham respiratory muscles training | Sham comparator | 4 weeks sham respiratory muscles training (THRESHOLD® IMT breathing trainer with "0" pressure level) followed by 12 weeks guided aerobic training - (treadmill walking) Receives: Other: sham respiratory muscles training; Other: aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Change in Peak VO2
Measured: 16 weeks
Secondary outcomes (6)
proBNP
Change in concentration of NT- proBNP from baseline
Measured: 4 weeks
proBNP
Change in concentration of NT- proBNP from baseline
Measured: 16 weeks
Respiratory muscle strength
Change in maximal inspiratory and expiratory pressures (PImax and PEmax) from baseline
Measured: 4 weeks
Respiratory muscle strength
Change in maximal inspiratory and expiratory pressures (PImax and PEmax) from baseline
Measured: 16 weeks
Neurohormone activity
Difference between Active and Control groups in Angiotensin II (A II) concentration from baseline
Measured: 4 weeks
Neurohormone activity
Change in concentration of Angiotensin II (A II) from baseline
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start30 Nov 2018
- Primary completion1 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lomonosov Moscow State University Medical Research and Educational Center
- Sponsor type
- University, hospital or other
- Collaborators
- Russian Heart Failure Society
- Responsible party
- Sponsor
- Investigators
- Yana A Orlova, Professor, Study chair, Moscow State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726905
- Sponsor's protocol ID
- mcmsuaadd001
- Acronym
- AEROFIT-HF
- Status last verified
- Nov 2022
- First submitted
- 30 Oct 2018
- Last updated
- 25 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Complex Exercises of the Respiratory Muscles Plus Aerobic Training vs. Aerobic Training in Patients With CHF and II-IV NYHA FC: Prospective Randomized Clinical Trial With Sham Control
- ClinicalTrials.gov ID
- NCT03726905
- Acronym / sponsor ID
- AEROFIT-HF / mcmsuaadd001
- Conditions
- Heart Failure
- Keywords
- CHF, exercise, aerobic, respiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lomonosov Moscow State University Medical Research and Educational CenterUniversity, hospital or other
- Collaborators
- Russian Heart Failure Society
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 1 Nov 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.
The aim of the study is to test the hypothesis that the physical rehabilitation starting with respiratory training followed by the aerobic exercises will have a more pronounced effect on clinical and functional indicators than the currently used physical rehabilitation based on aerobic training alone
Detailed description
Changes in the respiratory muscles play an important role in the pathophysiology of exercise intolerance in CHF patients. The weakness of the respiratory muscles leads to a decrease in the efficiency of breathing and the formation of a pathological type of breathing, in which the inhalation time is prolonged, and the expiration time is shortened. Patients with weak respiratory muscles have impaired functional status, as determined by peak oxygen consumption. The violation of the ratio of inspiratory time / to the total time of the respiratory cycle is associated with an increase in the activity of the sympathoadrenal system. The positive effect of respiratory muscle training on MIP, MEP, peak VО 2, VE, VE / VCO 2 slope, VE oscillation, rhythm variability, and quality of life parameters is shown. Decreased oxygenation of the respiratory muscles during intense physical exertion in patients with CHF may increase respiratory failure and provoke hyperactivation of the inspiratory metaboreflex, thereby aggravating exercise intolerance due to a decrease in muscular-muscular system perfusion due to redistribution of blood flow. In addition, it was shown that fatigue of the respiratory muscles increases the activity of the sympathetic nervous system and reduces blood flow in the muscles of the inactive limb due to adrenergic vasoconstriction. This response is most likely associated with metabolic stimulation of small afferent type III and IV fibers of the respiratory muscles, especially the diaphragm. Respiratory muscle training can minimize the effects of inspiration metaboreflex activation and prolong the duration of exercise. In addition, several studies have shown that the strength of the respiratory muscles in patients with HF correlates with central hemodynamic indices at rest, including cardiac output, mean pulmonary pressure and pulmonary vascular resistance. Several studies have shown that the mechanism that improves exercise tolerance in patients with HF after training the respiratory muscles is to increase the blood supply to the muscles of the limbs at rest and during exercise. Thus, the mechanisms of the effect of the weakness of the respiratory muscles on the pathogenesis of a decrease in the functional ability of patients are well studied. Both respiratory muscular and aerobic exercises of moderate effectiveness are recommended by leading medical communities as an effective means to improve the functional ability of patients, improve quality of life parameters, improve symptoms and reduce hospital admissions (level of evidence Level 1). At the same time, respiratory muscle training is recommended as the beginning of physical rehabilitation in patients with IV FC HF, and moderate-intensity aerobic training is recommended for patients with FC I-III FC. Also, in individual works abroad, the effects of respiratory muscle training on clinical CHF. However, according to the investigator's information, no studies have been carried out on the study of the method of functional training, including training of the respiratory muscles, as an obligatory initial stage of physical rehabilitation of patients with any functional class of HF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| respiratory muscles training | Experimental | Other: respiratory muscles training, Other: aerobic training4 weeks guided respiratory muscles training followed by 12 weeks guided aerobic training - (treadmill walking) |
| sham respiratory muscles training | Sham comparator | Other: sham respiratory muscles training, Other: aerobic training4 weeks sham respiratory muscles training (THRESHOLD® IMT breathing trainer with "0" pressure level) followed by 12 weeks guided aerobic training - (treadmill walking) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients aged 18 years and older (inclusive)
- Patients with stable heart failure of the II-III functional class.
- Signed patient informed consent to participate in the study.
- Left ventricular ejection fraction ≤40%, confirmed by the results of EchoCG no more than 3 months before the start of the study.
- Patients who can understand the objectives of this study and comply with the requirements of the Protocol.
Key exclusion criteria (28 listed)
- • Heart failure I and VI functional class
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 |
|---|---|---|
| respiratory muscles training4 weeks respiratory muscles training aimed on respiratory muscles endurance and lengthening expiration time | Other | respiratory muscles training |
| sham respiratory muscles training4 weeks sham respiratory muscles training with the help of breathing simulators, with a breathing resistance level set at 0 | Other | sham respiratory muscles training |
| aerobic training12 weeks treadmill walking | Other | respiratory muscles training, sham respiratory muscles training |
Primary outcome
Functional Capacity
Time frame: 16 weeks
Change in Peak VO2
6 secondary outcomes
proBNP
Time frame: 4 weeks
proBNP
Time frame: 16 weeks
Respiratory muscle strength
Time frame: 4 weeks
Respiratory muscle strength
Time frame: 16 weeks
Neurohormone activity
Time frame: 4 weeks
Neurohormone activity
Time frame: 16 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 25 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Yana A Orlova, Professor study chair
Moscow State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory muscles training and aerobic training in people with Heart Failure, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.
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 28 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 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Functional Capacity (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2022.