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

NCT ID: NCT06799104

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-01-31

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.

Conditions

Coronary Artery Disease; Class I Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study 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.

Group Type: EXPERIMENTAL

Pyramidal training

Intervention Type: 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.

Mediterranean diet

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Mediterranean diet

Intervention Type: 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.

Interventions

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. 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.

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rawda Mohamed Ahmed Mohamed El Komy

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeinab M Helmy, Professor

Role: STUDY_CHAIR

Cairo University

Ebtesam N Abdel-Mohsen, PhD

Role: STUDY_DIRECTOR

Cairo University

Hoda A Saad ELDin, PhD

Role: STUDY_DIRECTOR

Alexandria University

Locations

Cairo University

Cairo, Giza Governorate, Egypt

Countries

Egypt

Central Contacts

Rawda M ELkomy, B.Sc.

Role: CONTACT

rawda.elkomy@pua.edu.eg

00201551341126

Other Identifiers

P.T.REC/012/005563

Identifier Type: -

Identifier Source: org_study_id