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

ConditionsCoronary Artery DiseaseClass I Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-40
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Musculoskeletal problems.

Chronic pulmonary disease.

Missed more than two weeks of the program or want to terminate the program.

Unstable angina.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pyramidal training

    Other intervention

    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

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Experimental group:Experimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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

Time frame
12 weeks

Secondary outcomes

1

(lipid profile) Blood test

Blood sampling will conduct 48 hours before the first training session and 48 hours after the last training session. Participants will instruct to stop eating for at least eight hours prior to the blood sample.

Time frame
12 weeks
2

Anthropometric measurements

BMI was calculated by dividing body weight (kg) by the square of length (m2). Between 18.5-24.9 kg/m2 , BMI is defined as normal, between 25.0-29.9 kg/m2 as overweight, ≥30 kg/m2 as obesity, and ≥35 as severe obesity. WC was measured from the midpoint of the lateral iliac prominences and the lowest rib while standing. It was high considered as 88 cm and above in women, 102 cm and above in men. Hip circumference was measured around the widest part of the hip, and WHR was calculated by dividing WC (cm) by hip circumference (cm). It was high considered as 0.85 and above in women, 0.90 and above in men

Time frame
12 weeks
3

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

The IWQOL-Lite-CT is a 20-item patient-reported outcome (PRO) measure designed to assess the impact of changes in weight on patients' physical and psychosocial functioning. Each item employs a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). In addition to yielding a Total score, the final 20-item IWQOL-Lite-CT includes two primary domains: Physical (7 items) and Psychosocial (13 items)

Time frame
12 weeks
4

14-Item Mediterranean Diet Adherence Screener (MEDAS)

The MEDAS is a 14-item questionnaire requesting participants to report the habitual frequency of consumption or amount consumed of 12 main components of the MedDiet and two food habits related to the MedDiet. Each of the 14 items is scored 1 or 0, depending on whether participants adhere to each MedDiet component or not. If these conditions were not met, an item was assigned a score of 0. The resulting MEDAS-derived MedDiet score ranged from 0 to 14

Time frame
12 weeks

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Cairo University Status unavailable 12613, Cairo, Giza GovernorateEgyptEgypt

Sponsors and contacts

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Cairo University

Lead sponsor

Source ClinicalTrials.gov

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