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

NCT ID: NCT05637125

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-01-01

Brief Summary

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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

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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.

Conditions

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Effect of Different Types of Aerobic Training on Diastolic Heart Failure Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A

Group A received aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks.

Group Type ACTIVE_COMPARATOR

aerobic exercise for upper limb

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

aerobic exercise for lower limb

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Tamer Ibrahim Abo Elyazed

Ass.prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tamer Abo Elyazed

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

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Beni-Suef University

Banī Suwayf, Sharq, Egypt

Site Status

Countries

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Egypt

References

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Obaya HE, El-Moneim Abd El-Hakim AA, Fares HM, Eldin Saad MK, Abo Elyazed TI. Effect of different types of aerobic training on peak VO2 and ejection fraction for diastolic heart failure patients; a comparative randomized control trial. Physiother Res Int. 2024 Jan;29(1):e2044. doi: 10.1002/pri.2044. Epub 2023 Aug 3.

Reference Type DERIVED
PMID: 37537847 (View on PubMed)

Other Identifiers

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BeniSuefU2

Identifier Type: -

Identifier Source: org_study_id

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