Clinical trial NCT06626542: Effect of Intra-session Exercise Modes Sequence on Ventricular Function in Patients with Chronic Heart Failure
Official title: EFFECT of INTRA-SESSION EXERCISE MODES SEQUENCE on VENTRICULAR FUNCTION in PATIENTS with CHRONIC HEART FAILUIRE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 60
Sex: MALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 12 weeks
Secondary outcomes:
measure: The Minnesota living with heart failure questionnaire (MLWHFQ)
timeFrame: 12 weeks
measure: Cardiorespiratory fitness 6 minute walk test
timeFrame: 12 weeks
measure: Vo2 Max
timeFrame: 12 week
measure: Blood pressure
timeFrame: 12 weeks
measure: Rate of pressure product
timeFrame: 12 week
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: National Heart Institute
state: Agouza Giza Governorate
Study officials:
References: