Clinical Relevance of Different Training Intensities in Chronic Heart Failure.

Clinical Relevance and Prognostic Outcomes of Different Training Intensities for Cardiac Remodeling 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 .

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Other: Aerobic exercise training

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12316
    • Faculty of physical therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: High intensity aerobic training group(HIT); 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.	Other: Aerobic exercise training; bicycle ergometer exercise training
ACTIVE_COMPARATOR: Moderate intensity aerobic training group(MIT); 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.	Other: Aerobic exercise training; bicycle ergometer exercise training
ACTIVE_COMPARATOR: Low intensity aerobic training group(LIT); 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	Other: Aerobic exercise training; bicycle ergometer exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ejection fraction	represents left ventricular function measured by pulsed echocardiography	change from baseline to after 12 weeks
pro-brain natriuretic peptide (proBNP)	biomarker for heart failure measured by analysis of venous samples drawn	change from baseline to after 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minnesota Living With Heart Failure Questionnaire (MLWHF):	Questionnaire for measuring quality of life of heart failure patients	change from baseline to after 12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Heba Ahmed Abdeen, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ACTUAL): September 12, 2021
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: January 16, 2022
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (ACTUAL): January 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HF2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No