Effect of Different Types of Aerobic Training on Peak VO2 and Ejection Fraction for Diastolic Heart Failure Patients; a Comparative Randomized Control Trial
Primary Purpose
Effect of Different Types of Aerobic Training on Diastolic Heart Failure Patients
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aerobic exercise for upper limb
aerobic exercise for lower limb
Sponsored by
About this trial
This is an interventional supportive care trial for Effect of Different Types of Aerobic Training on Diastolic Heart Failure Patients focused on measuring Diastolic heart failure, ejection fraction, aerobic exercise, peak VO2
Eligibility Criteria
Inclusion Criteria: male gender under complete medical supervision left ventricular end diastolic dimension >5.5cm ejection fraction <50%. Exclusion Criteria: Orthopedic problems Mental disorders Metabolic disorders (D.M) Current treatment for cancer or active infection.
Sites / Locations
- Beni-Suef University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Group A received aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks.
received aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks.
Outcomes
Primary Outcome Measures
Ejection fraction
Vivid S5 cardiovascular ultrasound system (BT308), made in china, was used to measure ejection fraction.
peak VO2
Oxycon pro (ER900, Germany) cardiopulmonary exercise test unit was used to measure Peak Vo2
Secondary Outcome Measures
Full Information
NCT ID
NCT05637125
First Posted
November 24, 2022
Last Updated
November 24, 2022
Sponsor
Beni-Suef University
1. Study Identification
Unique Protocol Identification Number
NCT05637125
Brief Title
Effect of Different Types of Aerobic Training on Peak VO2 and Ejection Fraction for Diastolic Heart Failure Patients; a Comparative Randomized Control Trial
Official Title
Effect of Different Types of Aerobic Training on Peak VO2 and Ejection Fraction for Diastolic Heart Failure Patients; a Comparative Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef 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
Background: Heart failure is described by a lack of confirmed efficient therapies and exercise intolerance. Physical activity is related to a lower risk of adverse cardiovascular consequences, involving heart failure. The purpose of the study: determine the effect of different types of aerobic training on peak VO2 and ejection fraction in diastolic heart failure patients. Subject and methods: Forty eligible male patients with diastolic heart failure, aged between 50 - 60 years old, participated in this study. They were selected from an outpatient clinic of general Zagazig hospital and were assigned into 2 equal groups in numbers. The first group (A) received aerobic exercise for the upper limb in form of arm ergometer exercises, while the second group (B) received aerobic exercise for the lower limb in form of cycling. Training duration for both groups was 3 sessions/week for 12 weeks. Peak VO2, and ejection fraction of both groups were measured and compared pre and post-treatment. Results: There was no significant difference in the ejection fraction between groups post-treatment. There was a significant increase in the peak VO2 of group B compared with that of group A post-treatment. Conclusion: there is no effect of different types of aerobic training on ejection fraction and peak VO2 for diastolic heart failure patients, but lower limb exercise is more effective than upper limb exercise in improvement of peak VO2 for diastolic heart failure patients.
Detailed Description
Ejection fraction and peak VO2 of both groups were measured pre exercise program and after 12 weeks at the end of the study exercise program.
Vivid S5 cardiovascular ultrasound system (BT308), made in china, was used to measure ejection fraction.
Oxycon pro (ER900, Germany) cardiopulmonary exercise test unit was used to measure Peak Vo2
Treatment procedure:
Group A received aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks. Patient started with warming up for 5 minutes in form of stretching. Patients used arm ergometer without resistance for upper limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion, after 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session.
Group B received aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks. Patient started with warming up for 5 minutes. Patients used bicycle for lower limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion. After 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Different Types of Aerobic Training on Diastolic Heart Failure Patients
Keywords
Diastolic heart failure, ejection fraction, aerobic exercise, peak VO2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A received aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
received aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
aerobic exercise for upper limb
Intervention Description
aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks. Patient started with warming up for 5 minutes in form of stretching. Patients used arm ergometer without resistance for upper limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion, after 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session.
Intervention Type
Other
Intervention Name(s)
aerobic exercise for lower limb
Intervention Description
received aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks. Patient started with warming up for 5 minutes. Patients used bicycle for lower limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion. After 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session.
Primary Outcome Measure Information:
Title
Ejection fraction
Description
Vivid S5 cardiovascular ultrasound system (BT308), made in china, was used to measure ejection fraction.
Time Frame
12 weeks
Title
peak VO2
Description
Oxycon pro (ER900, Germany) cardiopulmonary exercise test unit was used to measure Peak Vo2
Time Frame
12 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male gender
under complete medical supervision
left ventricular end diastolic dimension >5.5cm
ejection fraction <50%.
Exclusion Criteria:
Orthopedic problems
Mental disorders
Metabolic disorders (D.M)
Current treatment for cancer or active infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamer Abo Elyazed
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-Suef University
City
Banī Suwayf
State/Province
Sharq
ZIP/Postal Code
11222
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Different Types of Aerobic Training on Peak VO2 and Ejection Fraction for Diastolic Heart Failure Patients; a Comparative Randomized Control Trial
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