Effect of Different Types of Aerobic Training on Peak VO2 and Ejection Fraction for Diastolic Heart Failure Patients; a Comparative Randomized Control Trial

November 24, 2022 updated by: Tamer Ibrahim Abo Elyazed, Beni-Suef University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharq
      • Banī Suwayf, Sharq, Egypt, 11222
        • Beni-Suef University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Group A received aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks.
Other: aerobic exercise for upper limb
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.
Active Comparator: Group B
received aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks.
Other: aerobic exercise for lower limb
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ejection fraction
Time Frame: 12 weeks
Vivid S5 cardiovascular ultrasound system (BT308), made in china, was used to measure ejection fraction.
12 weeks
peak VO2
Time Frame: 12 weeks
Oxycon pro (ER900, Germany) cardiopulmonary exercise test unit was used to measure Peak Vo2
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Tamer Abo Elyazed, Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

November 24, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

November 24, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeniSuefU2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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