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Completed

NCT Number: NCT05213546

Clinical Relevance of Different Training Intensities in Chronic Heart Failure.

To determine the efficacy of different aerobic exercise training intensities in patients with chronic heart failure.Forty five eligible male patients with chronic heart failure were randomly assigned into three groups( High intensity , moderate intensity and low intensity)groups .

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Key information

Age range

50 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Cairo, 12316, Egypt

About this study

Forty five eligible male patients with chronic heart failure secondary to ischemic heart disease were selected from National Heart Institute heart failure outpatient clinic , their ages ranged from 50-60 years old and their ejection fraction ranged from 30-40% ,they were randomly assigned into three groups :HIT Group: received High Intensity aerobic Training in the form of bicycle ergometer exercise for the lower limbs three times /week for three months.(n=15) MIT Group: received moderate Intensity aerobic Training in the form of bicycle ergometer exercise for the lower limbs three times /week for three months. .(n=15) LIT Group: received low Intensity aerobic Training in the form of bicycle ergometer exercise for the lower limbs three times /week for three months, Before and after intervention, the following measures were obtained: Echocardiograph parameter (EF%, and left ventricular internal dimension ) , prognostic biomarkers (proBNP), and quality of life .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with following criteria were included :
  • All patients ages were between 50 - 60 years old
  • Fractional shortening < 25% and ejection fraction < 40%
  • Sinus rhythm.
  • Heart Failure due to ischemic heart disease.
  • New York Heart Association (NYHA) class II-III.
  • Regular medical treatment.

Exclusion criteria

  • Patients with following criteria were excluded :
  • Chronic heart failure due to other causes
  • History of pulmonary disease (chronic obstructive lung disease, moderate to severe pulmonary hypertension).
  • Recent acute coronary syndrome or revascularization (3 months).
  • Exercise limited by angina or peripheral arterial occlusive disease;
  • Cerebrovascular or musculoskeletal disease preventing exercise testing or training.
  • Poorly controlled or exercise-induced cardiac arrhythmias
  • Logistic problems to attend regular exercise training sessions. Uncontrolled hypertension.

Treatment and study plan

Aerobic exercise training

Other

bicycle ergometer exercise training

Primary outcomes

  1. Ejection fraction

    Time frame: change from baseline to after 12 weeks

    represents left ventricular function measured by pulsed echocardiography

  2. pro-brain natriuretic peptide (proBNP)

    Time frame: change from baseline to after 12 weeks

    biomarker for heart failure measured by analysis of venous samples drawn

Secondary outcomes

  1. Minnesota Living With Heart Failure Questionnaire (MLWHF):

    Time frame: change from baseline to after 12 weeks

    Questionnaire for measuring quality of life of heart failure patients

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Relevance and Prognostic Outcomes of Different Training Intensities for Cardiac Remodeling in Chronic Heart Failure.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2022
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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