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Complex Exercises of the Respiratory Muscles Plus Aerobic Training vs. Aerobic Training in Patients With СHF (AEROFIT-HF)

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ClinicalTrials.gov Identifier: NCT03726905
Recruitment Status : Suspended (Study suspended because of COVID 19)
First Posted : November 1, 2018
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Russian Heart Failure Society
Information provided by (Responsible Party):
Lomonosov Moscow State University Medical Research and Educational Center

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE November 30, 2018
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
Functional Capacity [ Time Frame: 16 weeks ]
Change in Peak VO2
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
Cardio-respiratory fitness [ Time Frame: 16 weeks ]
Change in Peak VO2
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
  • proBNP [ Time Frame: 4 weeks ]
    Change in concentration of NT- proBNP from baseline
  • proBNP [ Time Frame: 16 weeks ]
    Change in concentration of NT- proBNP from baseline
  • Respiratory muscle strength [ Time Frame: 4 weeks ]
    Change in maximal inspiratory and expiratory pressures (PImax and PEmax) from baseline
  • Respiratory muscle strength [ Time Frame: 16 weeks ]
    Change in maximal inspiratory and expiratory pressures (PImax and PEmax) from baseline
  • Neurohormone activity [ Time Frame: 4 weeks ]
    Difference between Active and Control groups in Angiotensin II (A II) concentration from baseline
  • Neurohormone activity [ Time Frame: 16 weeks ]
    Change in concentration of Angiotensin II (A II) from baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • proBNP [ Time Frame: 16 weeks ]
    Change in NT- proBNP
  • maximal RespM strength [ Time Frame: 4 weeks ]
    Change in maximal inspiratory and expiratory pressures (PImax and PEmax)
  • maximal RespM strength [ Time Frame: 16 weeks ]
    Change in maximal inspiratory and expiratory pressures (PImax and PEmax)
  • Angiotensin II (A II) [ Time Frame: 4 weeks ]
    Change in A II
  • Angiotensin II (A II) [ Time Frame: 16 weeks ]
    Change in A II
Current Other Pre-specified Outcome Measures
 (submitted: November 19, 2018)
  • Change in health-related quality of life [ Time Frame: 4 weeks ]
    Minnesota Living with Heart Failure Questionnaire/ The quality of life between study groups and the change in quality of life over time between study groups.
  • Change in health-related quality of life [ Time Frame: 16 weeks ]
    Minnesota Living with Heart Failure Questionnaire. Assessed from baseline visit to 16 weeks follow-up visit.The quality of life between study groups and the change in quality of life over time between study groups using clinically accepted quality of life measures. MLHFQ
  • Anxiety and Depression [ Time Frame: 4 weeks ]
    Hospital Anxiety sand Depression Scale (HADS) The questionnaire comprises seven questions for anxiety and seven questions for depression.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21. The cut off for both scales in 11.
  • Anxiety and Depression [ Time Frame: 16 weeks ]
    Hospital Anxiety sand Depression Scale (HADS) The questionnaire comprises seven questions for anxiety and seven questions for depression.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21. The cut off for both scales in 11.
Original Other Pre-specified Outcome Measures
 (submitted: October 31, 2018)
  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: 16 weeks ]
    Change in score
  • HADS [ Time Frame: 16 weeks ]
    Change in score of anxiety and depression subscales
  • VE/VCO 2 slope [ Time Frame: 16 weeks ]
    Change in VE/VCO 2 slope
 
Descriptive Information
Brief Title  ICMJE Complex Exercises of the Respiratory Muscles Plus Aerobic Training vs. Aerobic Training in Patients With СHF
Official Title  ICMJE 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
Brief 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
The control group will be assigned an imitation of respiratory muscles training with the help of breathing simulators, with a breathing resistance level set at 0
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Other: respiratory muscles training
    4 weeks respiratory muscles training aimed on respiratory muscles endurance and lengthening expiration time
  • Other: sham respiratory muscles training
    4 weeks sham respiratory muscles training with the help of breathing simulators, with a breathing resistance level set at 0
  • Other: aerobic training
    12 weeks treadmill walking
Study Arms  ICMJE
  • Experimental: respiratory muscles training
    4 weeks guided respiratory muscles training followed by 12 weeks guided aerobic training - (treadmill walking)
    Interventions:
    • Other: respiratory muscles training
    • Other: aerobic training
  • Sham Comparator: sham respiratory muscles training
    4 weeks sham respiratory muscles training (THRESHOLD® IMT breathing trainer with "0" pressure level) followed by 12 weeks guided aerobic training - (treadmill walking)
    Interventions:
    • Other: sham respiratory muscles training
    • Other: aerobic training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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.
    • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03726905
Other Study ID Numbers  ICMJE mcmsuaadd001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lomonosov Moscow State University Medical Research and Educational Center
Study Sponsor  ICMJE Lomonosov Moscow State University Medical Research and Educational Center
Collaborators  ICMJE Russian Heart Failure Society
Investigators  ICMJE
Study Chair: Yana A Orlova, Professor Moscow State University
PRS Account Lomonosov Moscow State University Medical Research and Educational Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP