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Clinical Trials/NCT05213546
NCT05213546CompletedNot Applicable

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

Cairo University1 site in 1 country45 target enrollmentStarted: August 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Ejection fraction

Study Overview

Brief Summary

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 .

Detailed Description

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 .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 60 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Arms & Interventions

High intensity aerobic training group(HIT)

Active Comparator

15 patients who received High Intensity aerobic Training in the form of bicycle ergometer exercise for the lower limbs three times /week for three months.

Intervention: Aerobic exercise training (Other)

Moderate intensity aerobic training group(MIT)

Active Comparator

15 patients who received moderate Intensity aerobic Training in the form of bicycle ergometer exercise for the lower limbs three times /week for three months.

Intervention: Aerobic exercise training (Other)

Low intensity aerobic training group(LIT)

Active Comparator

15 patients who received low Intensity aerobic Training in the form of bicycle ergometer exercise for the lower limbs three times /week for three months

Intervention: Aerobic exercise training (Other)

Outcomes

Primary Outcomes

Ejection fraction

Time Frame: change from baseline to after 12 weeks

represents left ventricular function measured by pulsed echocardiography

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

  • Minnesota Living With Heart Failure Questionnaire (MLWHF):(change from baseline to after 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heba Ahmed Ali Abdeen

Assistant professor

Cairo University

Study Sites (1)

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