Clinical Relevance of Different Training Intensities in Chronic Heart Failure.

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213546
• Other study ID #: HF2021
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 1, 2021
• Est. primary completion date: September 12, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• Aerobic exercise training
bicycle ergometer exercise training

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection fraction	represents left ventricular function measured by pulsed echocardiography	change from baseline to after 12 weeks
Primary	pro-brain natriuretic peptide (proBNP)	biomarker for heart failure measured by analysis of venous samples drawn	change from baseline to after 12 weeks
Secondary	Minnesota Living With Heart Failure Questionnaire (MLWHF):	Questionnaire for measuring quality of life of heart failure patients	change from baseline to after 12 weeks