Clinical Relevance of Different Training Intensities in Chronic Heart Failure.

NCT ID: NCT05213546

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-10-01

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 .

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aerobic exercise training

Intervention Type: OTHER

bicycle ergometer exercise training

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.

Group Type: ACTIVE_COMPARATOR

Aerobic exercise training

Intervention Type: OTHER

bicycle ergometer exercise training

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

Group Type: ACTIVE_COMPARATOR

Aerobic exercise training

Intervention Type: OTHER

bicycle ergometer exercise training

Interventions

Aerobic exercise training

bicycle ergometer exercise training

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba Ahmed Ali Abdeen

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba Ahmed Abdeen, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Physical Therapy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

HF2021

Identifier Type: -

Identifier Source: org_study_id