Effect of Intra-session Exercise Modes Sequence on Ventricular Function in Patients With Chronic Heart Failure

December 27, 2025 updated by: Yasser Mostafa Mohamed Elhamamsy, Cairo University

EFFECT OF INTRA-SESSION EXERCISE MODES SEQUENCE ON VENTRICULAR FUNCTION IN PATIENTS WITH CHRONIC HEART FAILUIRE

The aim of this study was to investigate the effect of intra-session exercise modes sequence on ventricular function in patients with chronic heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sixty male patients with chronic heart failure will be recruited in this study from National Heart Institute Giza, Egypt. Their ages will be ranged from 55 to 65 years old and they will be randomly divided into three groups as following:

  1. Study group (A) includes 20 patients who will receive intra-session exercise modes sequence of aerobic cardiovascular training (CVT) then resistance training (RT) exercises in addition to routine treatment programme.
  2. Study group (B) includes 20 patients who will receive intra-session exercise modes sequence of resistance training (RT) then aerobic cardiovascular training (CVT) exercises in addition to routine treatment programme.
  3. Control group (C) includes 20 patients who will receive routine treatment programme only.

The exercise training programme for both study groups A and B will be applied once per day, three times per week for 12 consecutive weeks.

Inclusion criteria:

All participated patients will be:

  • Male patients with chronic heart failure and ages from 55 to 65 years old.
  • Class II and class III heart failure according to NYHA classification.
  • HFrEF category with LVEF <40% as documented by echocardiogram within <6 months.
  • Receiving the same medical treatment programme for at least 3 months.
  • Having a close level of functional capacity assessed by 6 minute walking test.

Exclusion criteria:

Patients who meet one of the following criteria will be excluded:

  • Uncontrolled atrial fibrillation.
  • Diabetes mellitus.
  • Myocardial infarction or recurrent angina within <3 months.
  • Patients with chronic chest diseases.
  • Severe stenotic valvular disease.
  • Clinically significant peripheral vascular disease.
  • Exercise-induced angina, ST segment changes or exercise induce AV block.
  • Patients with chronic renal failure.
  • Any cognitive impairment that interferes with prescribed exercise procedures.
  • Musculoskeletal or neurological limitation to physical exercise.

RESEARCH ETHICS

The protocol of this study will be approved by the ethics committee of scientific research at the Faculty of Physical Therapy, Cairo University. The study procedure will be explained in details for every patient before the initial assessment. All patients will be informed about the purpose, nature, and potential risks of the study, and a written informed consent will be obtained before participation in the study. The participants' right confidentiality will be observed strictly.

Study Type

Interventional

Enrollment (Actual)

60

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
    • Agouza Giza Governorate
      • Giza, Agouza Giza Governorate, Egypt, 12511
        • National Heart Institute

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male patients with chronic heart failure and ages from 55 to 65 years old.

    • Class II and class III heart failure according to NYHA classification.
    • HFrEF category with LVEF <40% as documented by echocardiogram within <6 months.
    • Receiving the same medical treatment programme for at least 3 months.
    • Having a close level of functional capacity assessed by 6 minute walking test

Exclusion Criteria:

  • • Uncontrolled atrial fibrillation.

    • Diabetes mellitus.
    • Myocardial infarction or recurrent angina within <3 months.
    • Patients with chronic chest diseases.
    • Severe stenotic valvular disease.
    • Clinically significant peripheral vascular disease.
    • Exercise-induced angina, ST segment changes or exercise induce AV block.
    • Patients with chronic renal failure.
    • Any cognitive impairment that interferes with prescribed exercise procedures.
    • Musculoskeletal or neurological limitation to physical exercise.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sequence of aerobic cardiovascular training (CVT) then resistance training (RT) exercises
Other: resistance and aerobic training exercises
resistance and aerobic training exercises
Other Names:
  • cardiac rehabilitation
Experimental: sequence of resistance training (RT) then aerobic cardiovascular training (CVT) exercises
Other: resistance and aerobic training exercises
resistance and aerobic training exercises
Other Names:
  • cardiac rehabilitation
Other: control group routine treatment programme only
Other: resistance and aerobic training exercises
resistance and aerobic training exercises
Other Names:
  • cardiac rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction
Time Frame: 12 weeks
left ventricular ejection fraction is measured by using echocardiography it is measured in percentage %
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Minnesota living with heart failure questionnaire (MLWHFQ)
Time Frame: 12 weeks
calculate minnasota living with heart failure questionnaire score 21 item MLHFQ uses a 6-point scale where 0 = no, 1= very little and 5= very much
12 weeks
Cardiorespiratory fitness 6 minute walk test
Time Frame: 12 weeks
after the test we calculate the distance patient walked in meters and we use this distance to evaluate the cardiopulmonary fitness
12 weeks
Vo2 Max
Time Frame: 12 week
by using distance from the 6MWT in meters we can calculate the vo2 max using specific equation
12 week
Blood pressure
Time Frame: 12 weeks
blood pressure systolic by using the sphygmomanometer palpatory method - diastolic by using the auscultatory method by sphygmomanometer and stethoscope
12 weeks
Rate of pressure product
Time Frame: 12 week
rate pressure product will be calculated by this equation : patient heart rate * systolic blood pressure / 1000
12 week

Collaborators and Investigators

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

Sponsor

Cairo 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)

September 3, 2023

Primary Completion (Actual)

August 27, 2025

Study Completion (Actual)

August 27, 2025

Study Registration Dates

First Submitted

June 2, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 27, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004786

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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