Coronary Artery DiseaseNCT06799104
EFFECT OF PYRAMIDAL TRAINING ON EPICARDIAL FAT FOR CORONARY ARTERY DISEASE PREVENTION
A study testing Pyramidal training and Mediterranean diet in people with Coronary Artery Disease and Class I Obesity, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Coronary Artery Disease, Class I Obesity
- What is being tested?
- Pyramidal training and Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Being tested
- Pyramidal training, Mediterranean diet
- Keywords
- Pyramidal Training, Epicardial Fat,Coronary artery disease.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyramidal trainingOther
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.
- Level one: will be set as a 20% walking of Karvonen formula.
- Level two: will be set as a 30% running of Karvonen formula.
- Level three: will be set as a 50%running of Karvonen formula.
- Level four: will be set as a 70% running of Karvonen formula.
- Level five: will be set as a 80% running of Karvonen formula.
Mediterranean dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pyramidal training; Other: Mediterranean diet |
| Control group | Active comparator | This group will include 25 patients who will receive Mediterranean diet for (12 weeks). Receives: Other: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (4)
(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.
Measured: 12 weeks
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
Measured: 12 weeks
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)
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawda Mohamed Ahmed Mohamed El Komy, Cairo University
- Investigators
- Zeinab M Helmy, Professor, Study chair, Cairo UniversityEbtesam N Abdel-Mohsen, PhD, Study director, Cairo UniversityHoda A Saad ELDin, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799104
- Sponsor's protocol ID
- P.T.REC/012/005563
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF PYRAMIDAL TRAINING ON EPICARDIAL FAT FOR CORONARY ARTERY DISEASE PREVENTION
- ClinicalTrials.gov ID
- NCT06799104
- Acronym / sponsor ID
- P.T.REC/012/005563
- Conditions
- Coronary Artery Disease, Class I Obesity
- Keywords
- Pyramidal Training, Epicardial Fat,Coronary artery disease.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: | Experimental | Other: Pyramidal training, Other: Mediterranean dietThis 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 | Active comparator | Other: Mediterranean dietThis group will include 25 patients who will receive Mediterranean diet for (12 weeks). |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fifty females' patients with class I obesity (BMI 30 to 34.9 kg/m2, Waist circumference > 88 cm).
Key exclusion criteria (13 listed)
- Patients with conditions will be excluded such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyramidal trainingPyramidal 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. | Other | Experimental group: |
| Mediterranean dietMediterranean 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. | Other | Control group, Experimental group: |
Primary outcome
Epicardial adipose tissue thickness.
Time frame: 12 weeks
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
4 secondary outcomes
(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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeinab M Helmy, Professor study chair
Cairo University
Ebtesam N Abdel-Mohsen, PhD study director
Cairo University
Hoda A Saad ELDin, PhD study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyramidal training and Mediterranean diet in people with Coronary Artery Disease and Class I Obesity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rawda M ELkomy, B.Sc. (00201551341126, rawda.elkomy@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial adipose tissue thickness. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.