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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.

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

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.
Show all 28Show fewer
  • 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.

Russia1 site
  • Julia Begrambekova

    Moscow, Moscow Oblast, 119620

Other trials in Russia

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 groups in NCT03726905
Study groupRoleWhat they receive
respiratory muscles trainingExperimental4 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 trainingSham comparator4 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.

  1. Functional Capacity

    Change in Peak VO2

    Measured: 16 weeks

Secondary outcomes (6)
  1. proBNP

    Change in concentration of NT- proBNP from baseline

    Measured: 4 weeks

  2. proBNP

    Change in concentration of NT- proBNP from baseline

    Measured: 16 weeks

  3. Respiratory muscle strength

    Change in maximal inspiratory and expiratory pressures (PImax and PEmax) from baseline

    Measured: 4 weeks

  4. Respiratory muscle strength

    Change in maximal inspiratory and expiratory pressures (PImax and PEmax) from baseline

    Measured: 16 weeks

  5. Neurohormone activity

    Difference between Active and Control groups in Angiotensin II (A II) concentration from baseline

    Measured: 4 weeks

  6. 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.

  1. First posted1 Nov 2018
  2. Study start30 Nov 2018
  3. Primary completion1 Dec 2020
  4. Study completion30 Dec 2020

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (actual)
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

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.

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