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Not yet recruiting NCT06799104

EFFECT OF PYRAMIDAL TRAINING ON EPICARDIAL FAT FOR CORONARY ARTERY DISEASE PREVENTION

No phase Interventional Coronary Artery Disease Class I Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pyramidal training, Mediterranean diet.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Class I Obesity. Basic parameters: 30 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other Pyramidal training
    Pyramidal training prescription:Mode of exercise: aerobic interval training. Intensity: ranging from 20-80% from THR. Duration: 40 minutes per session.Frequency: Three sessions per week for 12 weeks. The course of the program will be 2 sets of pyramidal training with 10 minutes for rest between them. Each set will be 5 levels of incremental and 5 levels of decremental aerobic exercise and each level 2 minutes on a treadmill. 1. Level one: will be set as a 20% walking of Karvonen formula. 2. Le
  • Other Mediterranean diet
    Mediterranean diet: Meal Composition Main meals consumed daily should be a combination of three elements: cereals, vegetables and fruits, and a small quantity of legumes, beans or other (though not in every meal). Cereals in the form of bread, pasta, rice, couscous or bulgur (cracked wheat) should be consumed as one-two servings per meal. Vegetable consumption should amount to two or more servings per day, in raw form for at least one of the two main meals (lunch and dinner). Fruit should be co

Primary outcome measures

  • Epicardial adipose tissue thickness. [Time frame: 12 weeks]
Secondary outcome measures (4)
  • (lipid profile) Blood test [Time frame: 12 weeks]
  • Anthropometric measurements [Time frame: 12 weeks]
  • Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) [Time frame: 12 weeks]
  • 14-Item Mediterranean Diet Adherence Screener (MEDAS) [Time frame: 12 weeks]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT06799104 · P.T.REC/012/005563

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗