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Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis

Primary Purpose

Obesity, Atherosclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pyramidal training by treadmill
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, risk factor, lipid profile

Eligibility Criteria

30 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

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

receive diet health advises.

Outcomes

Primary Outcome Measures

atherogenic index of plasma
blood analysis

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06077552
Brief Title
Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis
Official Title
Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis in Women With Central Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Atherosclerosis
Keywords
obesity, risk factor, lipid profile

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advises.
Arm Title
control group
Arm Type
No Intervention
Arm Description
receive diet health advises.
Intervention Type
Other
Intervention Name(s)
pyramidal training by treadmill
Intervention Description
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 Measure Information:
Title
atherogenic index of plasma
Description
blood analysis
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Waist circumference
Description
tape measurement
Time Frame
8 weeks
Title
Body mass index
Description
measurement weight on height
Time Frame
8 weeks
Title
lipid profile
Description
blood analysis
Time Frame
8 weeks
Title
insulin resistance
Description
homeostatic model assessment for insulin resistance
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marwa elsayed, PhD
Phone
0201156033818
Email
marwadd999@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa elsayed, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
State/Province
Dokki
ZIP/Postal Code
11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
marwa M elsayed, phd
Phone
01156033818
Ext
02
Email
marwadd999@gmail.com
First Name & Middle Initial & Last Name & Degree
marwa M elsayed, ph.d
Phone
01156033818
Ext
02
Email
marwadd999@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
journal publishing article
IPD Sharing Time Frame
after 4 years of publishing
IPD Sharing Access Criteria
publishing journal web site

Learn more about this trial

Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis

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