Heart FailureNCT06626542
Effect of Intra-session Exercise Modes Sequence on Ventricular Function in Patients With Chronic Heart Failure
A study testing resistance and aerobic training exercises in people with Heart Failure, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 65 years, men only
- Conditions the study is for
- Heart Failure
- What is being tested?
- resistance and aerobic training exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Sep 2023to 27 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Heart Failure
- Being tested
- resistance and aerobic training exercises
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance and aerobic training exercisesOther
Also called cardiac rehabilitation
resistance and aerobic training exercises
| Study group | Role | What they receive |
|---|---|---|
| sequence of aerobic cardiovascular training (CVT) then resistance training (RT) exercises | Experimental | Not described Receives: Other: resistance and aerobic training exercises |
| sequence of resistance training (RT) then aerobic cardiovascular training (CVT) exercises | Experimental | Not described Receives: Other: resistance and aerobic training exercises |
| control group routine treatment programme only | Other | Not described Receives: Other: resistance and aerobic training exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
left ventricular ejection fraction is measured by using echocardiography it is measured in percentage %
Measured: 12 weeks
Secondary outcomes (5)
The Minnesota living with heart failure questionnaire (MLWHFQ)
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
Measured: 12 weeks
Cardiorespiratory fitness 6 minute walk test
after the test we calculate the distance patient walked in meters and we use this distance to evaluate the cardiopulmonary fitness
Measured: 12 weeks
Vo2 Max
by using distance from the 6MWT in meters we can calculate the vo2 max using specific equation
Measured: 12 week
Blood pressure
blood pressure systolic by using the sphygmomanometer palpatory method - diastolic by using the auscultatory method by sphygmomanometer and stethoscope
Measured: 12 weeks
Rate of pressure product
rate pressure product will be calculated by this equation : patient heart rate * systolic blood pressure / 1000
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start3 Sep 2023
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mostafa Mohamed Elhamamsy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626542
- Sponsor's protocol ID
- P.T.REC/012/004786
- Status last verified
- Oct 2024
- First submitted
- 2 Jun 2024
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF INTRA-SESSION EXERCISE MODES SEQUENCE ON VENTRICULAR FUNCTION IN PATIENTS WITH CHRONIC HEART FAILUIRE
- ClinicalTrials.gov ID
- NCT06626542
- Acronym / sponsor ID
- P.T.REC/012/004786
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients with chronic heart failure and ages from 55 to 65 years old.
Key exclusion criteria (10 listed)
- • Uncontrolled atrial fibrillation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resistance and aerobic training exercisesAlso: cardiac rehabilitationresistance and aerobic training exercises | Other | control group routine treatment programme only, sequence of aerobic cardiovascular training (CVT) then resistance training (RT) exercises, sequence of resistance training (RT) then aerobic cardiovascular training (CVT) exercises |
Primary outcome
Left ventricular ejection fraction
Time frame: 12 weeks
left ventricular ejection fraction is measured by using echocardiography it is measured in percentage %
5 secondary outcomes
The Minnesota living with heart failure questionnaire (MLWHFQ)
Time frame: 12 weeks
Cardiorespiratory fitness 6 minute walk test
Time frame: 12 weeks
Vo2 Max
Time frame: 12 week
Blood pressure
Time frame: 12 weeks
Rate of pressure product
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance and aerobic training exercises in people with Heart Failure, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.