Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis

February 14, 2024 updated by: marwa mahmoud elsayed mahmoud, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dokki
      • Cairo, Dokki, Egypt, 11432
        • Recruiting
        • Faculty of Physical Therapy
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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).

    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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advises.
Other: 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
No Intervention: control group
receive diet health advises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
atherogenic index of plasma
Time Frame: 8 weeks
blood analysis
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: 8 weeks
tape measurement
8 weeks
Body mass index
Time Frame: 8 weeks
measurement weight on height
8 weeks
lipid profile
Time Frame: 8 weeks
blood analysis
8 weeks
insulin resistance
Time Frame: 8 weeks
homeostatic model assessment for insulin resistance
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: marwa elsayed, PhD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

journal publishing article

IPD Sharing Time Frame

after 4 years of publishing

IPD Sharing Access Criteria

publishing journal web site

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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