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

NCT06799104 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005563
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Class I Obesity

Keywords

Pyramidal Training, Epicardial Fat,Coronary artery disease.

Outcome Measures

Primary Outcomes (1)

• Epicardial adipose tissue thickness.

  The echo measurements for EATT will be taken in standard parasternal view in the left lateral decubitus position by an experienced cardiologist, and the mean values between long- and short-axis views will record. The EAT is identify as the echo-free space between the outer wall of the myocardium and the visceral layer of the pericardium. The thickness is measure perpendicularly on the free wall of the right ventricle at end systole in three to ten cardiac cycles

  12 weeks

Secondary Outcomes (4)

• (lipid profile) Blood test

  12 weeks

• Anthropometric measurements

  12 weeks

• Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)

  12 weeks

• 14-Item Mediterranean Diet Adherence Screener (MEDAS)

  12 weeks

Study Arms (2)

Experimental group:

EXPERIMENTAL

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.

Other: Pyramidal training; Other: Mediterranean diet

Control group

ACTIVE COMPARATOR

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

Other: Mediterranean diet

Interventions

Pyramidal training OTHER

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. Level two: will be set as a 30% running of Karvonen formula. 3. Level three: will be set as a 50%running of Karvonen formula. 4. Level four: will be set as a 70% running of Karvonen formula. 5. Level five: will be set as a 80% running of Karvonen formula.

Experimental group:

Mediterranean diet OTHER

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 considered as the primary form of dessert, with one-two servings per meal.

Control group; Experimental group:

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Zeinab M Helmy, Professor

  Cairo University

  STUDY CHAIR

• Ebtesam N Abdel-Mohsen, PhD

  Cairo University

  STUDY DIRECTOR

• Hoda A Saad ELDin, PhD

  Alexandria University

  STUDY DIRECTOR

Central Study Contacts

Rawda M ELkomy, B.Sc.

CONTACT

00201551341126; rawda.elkomy@pua.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

EG (1)