Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06077552
Collaborator
(none)
60
1
2
15
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: pyramidal training by treadmill
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis in Women With Central Obesity
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Jan 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. atherogenic index of plasma [8 weeks]

    blood analysis

Secondary Outcome Measures

  1. Waist circumference [8 weeks]

    tape measurement

  2. Body mass index [8 weeks]

    measurement weight on height

  3. lipid profile [8 weeks]

    blood analysis

  4. insulin resistance [8 weeks]

    homeostatic model assessment for insulin resistance

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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).
  1. Participants with uncontrolled pulmonary disease. (e.g., Exaggerated chronic obstructive pulmonary disease, acute asthma).

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

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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Physical Therapy Cairo Dokki Egypt 11432

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Marwa elsayed, PhD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
marwa mahmoud elsayed mahmoud, assistant professor, Cairo University
ClinicalTrials.gov Identifier:
NCT06077552
Other Study ID Numbers:
  • P.T.REC/012/004666
First Posted:
Oct 11, 2023
Last Update Posted:
Oct 11, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by marwa mahmoud elsayed mahmoud, assistant professor, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2023