NCT06626542

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2025

Completed
Last Updated

January 2, 2026

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

June 2, 2024

Last Update Submit

December 27, 2025

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction

    left ventricular ejection fraction is measured by using echocardiography it is measured in percentage %

    12 weeks

Secondary Outcomes (5)

  • The Minnesota living with heart failure questionnaire (MLWHFQ)

    12 weeks

  • Cardiorespiratory fitness 6 minute walk test

    12 weeks

  • Vo2 Max

    12 week

  • Blood pressure

    12 weeks

  • Rate of pressure product

    12 week

Study Arms (3)

sequence of aerobic cardiovascular training (CVT) then resistance training (RT) exercises

EXPERIMENTAL
Other: resistance and aerobic training exercises

sequence of resistance training (RT) then aerobic cardiovascular training (CVT) exercises

EXPERIMENTAL
Other: resistance and aerobic training exercises

control group routine treatment programme only

OTHER
Other: resistance and aerobic training exercises

Interventions

resistance and aerobic training exercisesOTHER

resistance and aerobic training exercises

Also known as: cardiac rehabilitation
control group routine treatment programme onlysequence of aerobic cardiovascular training (CVT) then resistance training (RT) exercisessequence of resistance training (RT) then aerobic cardiovascular training (CVT) exercises

Eligibility Criteria

Age55 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmales only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Institute

Giza, Agouza Giza Governorate, 12511, Egypt

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yasser Mostafa Mohamed El-hamamsy

Study Record Dates

First Submitted

June 2, 2024

First Posted

October 4, 2024

Study Start

September 3, 2023

Primary Completion

August 27, 2025

Study Completion

August 27, 2025

Last Updated

January 2, 2026

Record last verified: 2024-10

Locations

EG(1)