Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis

Not Applicable

Recruiting

• Conditions: Atherosclerosis; Obesity
• Interventions: Other: pyramidal training by treadmill

• Registration Number: NCT06077552
• Lead Sponsor: Cairo University

Brief Summary

The study will be conducted on fifty women with central obesity. Their ages will be from 30-40 years old. They will be selected from Al Hayat specialized Hospital in Cairo, Egypt and The participants will be randomly assigned into two equal groups:

Group (A): study group, 25 participants will receive pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advices.

Group (B): Control group, 25 participants will receive diet health advices. The subjects will be selected from El Haya specialized Hospital, Cairo.

Detailed Description

The study will be conducted on fifty women with central obesity. Their ages will be from 30-40 years old. They will be selected from Al Hayat specialized Hospital in Cairo, Egypt and The participants will be randomly assigned into two equal groups:

Group (A): study group, 25 participants will receive pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advices.

Group (B): Control group, 25 participants will receive diet health advices. The subjects will be selected from El Haya specialized Hospital, Cairo. Before starting the procedure the participants target heart rate (THR) will be calculated from Karvonen formula as follow: target heart rate (THR) = maximum heart rate (HRmax) - resting heart rate × intensity + resting heart rate(RHR)(Yabe et al.,2021).

The formula 208-0.7•age yield more precise estimates of HRmax over a wide age range (Nes et al., 2013).

After calculating THR, the study group participants will be on a pyramidal training program of incremental and decremental levels as follow:

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. All these levels will be ranked according to a percentage from the THR; the ranking will be as follow:

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 The whole program will be 40 minutes with warm up and cool down 5 minutes of stretch exercise for each. Participants will be asked to get on the treadmill and start the program, the therapist is monitoring the heart rate by using a pulse oximeter, and when the participants reach targeted percent of Karvonen formula, the therapist set the treadmill by increasing the speed to enter or start the up next level till reaching the highest level then start the decremental phase of the pyramidal training. The therapist shifts between the level by time or targeted percent of Karvonen formula which comes first.

Study Timeline

• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-11
• Study Start: 2023-11-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 1. Fifty women with central obesity. 2) Waist circumference > 88 cm. 3) Their age will be ranged from 30-40years old. 4) Body mass index (BMI) from 30 to 34.9 kg/m2. 5) High normal or abnormal lipid profile (total cholesterol > 200 mg/dl, HDL< 35 mg/dl, or triglycerides >150 mg/dl) and atherogenic index of plasma (AIP) ranges 0.11-0.21 6) HOMA-IR > 2.9 7) They are clinically and medically stable. 8) All participants are sedentary activity level according to physical activity index.

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Exclusion Criteria

• 1. Participants with musculoskeletal problems (e.g., Sever osteoarthritis or difficulties in ambulation).

  2. Participants with uncontrolled pulmonary disease. (e.g., Exaggerated chronic obstructive pulmonary disease, acute asthma).

  3. Any participants who missed more than two weeks of the program or want to terminate the program.

  4. Participants with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.

  5. The participants have hearing impairment or mental disorders. 6) Implanted pacemaker. 7) Diabetes and hypertension.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	pyramidal training by treadmill	pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advises.

Primary Outcome Measures

Name	Time	Method
atherogenic index of plasma	8 weeks	blood analysis

Secondary Outcome Measures

Name	Time	Method
lipid profile	8 weeks	blood analysis
insulin resistance	8 weeks	homeostatic model assessment for insulin resistance
Waist circumference	8 weeks	tape measurement
Body mass index	8 weeks	measurement weight on height

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Cairo, Dokki, Egypt