Clinical trial NCT05213546: Clinical Relevance of Different Training Intensities in Chronic Heart Failure.
Official title: Clinical Relevance and Prognostic Outcomes of Different Training Intensities for Cardiac Remodeling in Chronic Heart Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 45
Sex: MALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Ejection fraction
timeFrame: change from baseline to after 12 weeks
measure: pro-brain natriuretic peptide (proBNP)
timeFrame: change from baseline to after 12 weeks
Secondary outcomes:
measure: Minnesota Living With Heart Failure Questionnaire (MLWHF):
timeFrame: change from baseline to after 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Cairo University
name: Heba Ahmed Abdeen, PhD
role: PRINCIPAL_INVESTIGATOR
References: