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

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT05637125
Collaborator
(none)
40
1
2
5
8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: aerobic exercise for upper limb
  • Other: aerobic exercise for lower limb
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Aug 1, 2021
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Ejection fraction [12 weeks]

    Vivid S5 cardiovascular ultrasound system (BT308), made in china, was used to measure ejection fraction.

  2. peak VO2 [12 weeks]

    Oxycon pro (ER900, Germany) cardiopulmonary exercise test unit was used to measure Peak Vo2

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beni-Suef University Banī Suwayf Sharq Egypt 11222

Sponsors and Collaborators

  • Beni-Suef University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tamer Ibrahim Abo Elyazed, Ass.prof, Beni-Suef University
ClinicalTrials.gov Identifier:
NCT05637125
Other Study ID Numbers:
  • BeniSuefU2
First Posted:
Dec 5, 2022
Last Update Posted:
Dec 5, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tamer Ibrahim Abo Elyazed, Ass.prof, Beni-Suef University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2022