NCT03726905

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

October 30, 2018

Last Update Submit

November 21, 2022

Conditions

Heart Failure

Keywords

CHFexerciseaerobicrespiratory muscle training

Outcome Measures

Primary Outcomes (1)

  • Functional Capacity

    Change in Peak VO2

    16 weeks

Secondary Outcomes (6)

  • proBNP

    4 weeks

  • proBNP

    16 weeks

  • Respiratory muscle strength

    4 weeks

  • Respiratory muscle strength

    16 weeks

  • Neurohormone activity

    4 weeks

  • +1 more secondary outcomes

Other Outcomes (4)

  • Change in health-related quality of life

    4 weeks

  • Change in health-related quality of life

    16 weeks

  • Anxiety and Depression

    4 weeks

  • +1 more other outcomes

Study Arms (2)

respiratory muscles training

EXPERIMENTAL

4 weeks guided respiratory muscles training followed by 12 weeks guided aerobic training - (treadmill walking)

Other: respiratory muscles trainingOther: 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)

Other: sham respiratory muscles trainingOther: aerobic training

Interventions

respiratory muscles trainingOTHER

4 weeks respiratory muscles training aimed on respiratory muscles endurance and lengthening expiration time

respiratory muscles training
sham respiratory muscles trainingOTHER

4 weeks sham respiratory muscles training with the help of breathing simulators, with a breathing resistance level set at 0

sham respiratory muscles training
aerobic trainingOTHER

12 weeks treadmill walking

respiratory muscles trainingsham respiratory muscles training

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julia Begrambekova

Moscow, Moscow Oblast, 119620, Russia

Location

MeSH Terms

Conditions

Heart FailureMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Yana A Orlova, Professor

    Moscow State University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 1, 2018

Study Start

November 30, 2018

Primary Completion

December 1, 2020

Study Completion

December 30, 2020

Last Updated

November 25, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)