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Completed

NCT Number: NCT06077552

Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis

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.

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Key information

Age range

30 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Cairo, Dokki, 11432, Egypt

About this study

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:

  • 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • 1) Participants with musculoskeletal problems (e.g., Sever osteoarthritis or difficulties in ambulation).
  • Participants with uncontrolled pulmonary disease. (e.g., Exaggerated chronic obstructive pulmonary disease, acute asthma).
  • Any participants who missed more than two weeks of the program or want to terminate the program.
  • Participants with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.
  • The participants have hearing impairment or mental disorders. 6) Implanted pacemaker. 7) Diabetes and hypertension.

Treatment and study plan

pyramidal training by treadmill

Other

pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advises

Primary outcomes

  1. atherogenic index of plasma

    Time frame: 8 weeks

    blood analysis

Secondary outcomes

  1. Waist circumference

    Time frame: 8 weeks

    tape measurement

  2. Body mass index

    Time frame: 8 weeks

    measurement weight on height

  3. lipid profile

    Time frame: 8 weeks

    blood analysis

  4. insulin resistance

    Time frame: 8 weeks

    homeostatic model assessment for insulin resistance

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis in Women With Central Obesity

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 11, 2023
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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