Clinical Relevance of Different Training Intensities in Chronic Heart Failure.

NCT05213546 | Completed

• 1 other identifier: HF2021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 .

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Minnesota Living With Heart Failure Questionnaire (MLWHF):

  change from baseline to after 12 weeks

Study Arms (3)

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.

Other: Aerobic exercise training

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.

Other: Aerobic exercise training

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

Other: Aerobic exercise training

Interventions

Aerobic exercise training OTHER

bicycle ergometer exercise training

High intensity aerobic training group(HIT); Low intensity aerobic training group(LIT); Moderate intensity aerobic training group(MIT)

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, 12316, Egypt

Location

Study Officials

• Heba Ahmed Abdeen, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: January 28, 2022
• Study Start: August 1, 2020
• Primary Completion: September 12, 2021
• Study Completion: October 1, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)