Back to resultsClinical Relevance of Different Training Intensities in Chronic Heart Failure.
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure
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.
Sites / Locations
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
High intensity aerobic training group(HIT)
Moderate intensity aerobic training group(MIT)
Low intensity aerobic training group(LIT)
Arm Description
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.
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.
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
Outcomes
Primary Outcome Measures
Ejection fraction
represents left ventricular function measured by pulsed echocardiography
pro-brain natriuretic peptide (proBNP)
biomarker for heart failure measured by analysis of venous samples drawn
Secondary Outcome Measures
Minnesota Living With Heart Failure Questionnaire (MLWHF):
Questionnaire for measuring quality of life of heart failure patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05213546
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
September 12, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High intensity aerobic training group(HIT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Moderate intensity aerobic training group(MIT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low intensity aerobic training group(LIT)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Aerobic exercise training
Intervention Description
bicycle ergometer exercise training
Primary Outcome Measure Information:
Title
Ejection fraction
Description
represents left ventricular function measured by pulsed echocardiography
Time Frame
change from baseline to after 12 weeks
Title
pro-brain natriuretic peptide (proBNP)
Description
biomarker for heart failure measured by analysis of venous samples drawn
Time Frame
change from baseline to after 12 weeks
Secondary Outcome Measure Information:
Title
Minnesota Living With Heart Failure Questionnaire (MLWHF):
Description
Questionnaire for measuring quality of life of heart failure patients
Time Frame
change from baseline to after 12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba Ahmed Abdeen, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
ZIP/Postal Code
12316
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Relevance of Different Training Intensities in Chronic Heart Failure.
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