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Набор скоро начнётся NCT06799104

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

Без фазы С лечением Coronary Artery Disease Class I Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pyramidal training, Mediterranean diet.
Кому может быть актуально
Состояния в реестре: Coronary Artery Disease, Class I Obesity. Базовые параметры: 30 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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
  • Другое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Египет · 1 центр
  • Cairo University — Cairo

Идентификаторы

NCT: NCT06799104 · P.T.REC/012/005563

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗