Clinical trial NCT06799104: EFFECT OF PYRAMIDAL TRAINING ON EPICARDIAL FAT FOR CORONARY ARTERY DISEASE PREVENTION
Official title: EFFECT OF PYRAMIDAL TRAINING ON EPICARDIAL FAT FOR CORONARY ARTERY DISEASE PREVENTION
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Class I Obesity
Keywords: Pyramidal Training, Epicardial Fat,Coronary artery disease.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To show the effect of pyramidal training for coronary artery disease prevention on:

-Epicardial fat, BMI, Waist circumference (WC), Lipid profile, Quality of life and Mediterranean Diet Adherence.

Detailed description: Back Ground: Coronary heart disease (CHD) is a type of ischemic heart disease characterized by atherosclerotic plaque accumulation in the coronary arteries.Obesity leads to coronary artery disease (CAD) in part through an inflammatory process that accelerates atherosclerotic plaque formation which may start as early as childhood. Epicardial adipose tissue (EAT) is the Visceral adipose tissue (VAT) of the heart .EAT has unique embryologic, anatomic, and histologic features, including smaller adipocytes and higher prevalence of immune cells when compared to subcutaneous adipose tissue (SAT).

Purpose: To show the effect of pyramidal training for coronary artery disease prevention on:

-Epicardial fat, BMI, Waist circumference (WC), Lipid profile, Quality of life and Mediterranean Diet Adherence.

Methods: This study is Randomize Control Trail that will be carried out on 50 females' patients and will be selected from the Outpatient clinics at Pharos University. Patient will be randomly assigned to two groups.

Experimental group:

This group will include 25 patients who will receive pyramidal aerobic training by treadmill for 40 minutes per session (three sessions per week) for (12 weeks) in addition to Mediterranean diet.

Control group:

This group will include 25 patients who will receive Mediterranean diet for (12 weeks).

Results: Data analysis with Independent t-test will be used to compare the baseline parameters between the intervention and control groups. Repeated measures ANOVA will be used to compare the changes in EATT, anthropometrics and lipid levels at the baseline and after 12 weeks between the two groups.

Keywords: Pyramidal Training, Epicardial Fat, Coronary artery disease.

Eligibility criteria: Inclusion Criteria:

* Fifty females' patients with class I obesity (BMI 30 to 34.9 kg/m2, Waist circumference \> 88 cm).

  * Their age ranges from 30-40 years old.
  * Dyslipidemia and lipid profile as follow (total cholesterol high: 240 mg/dl, HDL less than 40 mg/dl, LDL high: 160-189 mg/dL and triglycerides high: 200-499 mg/dl).
  * All patients will be clinically and medically stable when attending the study.

Exclusion Criteria:

* Patients with conditions will be excluded such as:

  * Musculoskeletal problems.
  * Chronic pulmonary disease.
  * Missed more than two weeks of the program or want to terminate the program.
  * Unstable angina.
  * Acute illness.
  * Uncontrolled cardiac arrhythmia.
  * Decompensated heart failure.
  * Cognitive impairment or mental disorders.
  * Systolic blood pressure higher than 180, and/or diastolic blood pressure over 100mmHg.
  * DVT.
  * Multiple food allergies/intolerances or gastrointestinal difficulties of the prescribed diet.
  * Cancer (have special nutritional and training needs).

Primary outcomes:
measure: Epicardial adipose tissue thickness.
timeFrame: 12 weeks
Secondary outcomes:
measure: (lipid profile) Blood test
timeFrame: 12 weeks
measure: Anthropometric measurements
timeFrame: 12 weeks
measure: Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
timeFrame: 12 weeks
measure: 14-Item Mediterranean Diet Adherence Screener (MEDAS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Zeinab M Helmy, Professor
role: STUDY_CHAIR
affiliation: Cairo University
name: Ebtesam N Abdel-Mohsen, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Hoda A Saad ELDin, PhD
role: STUDY_DIRECTOR
References: