NCT06077552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

October 5, 2023

Last Update Submit

February 15, 2025

Conditions

Keywords

obesityrisk factorlipid profile

Outcome Measures

Primary Outcomes (1)

  • atherogenic index of plasma

    blood analysis

    8 weeks

Secondary Outcomes (4)

  • Waist circumference

    8 weeks

  • Body mass index

    8 weeks

  • lipid profile

    8 weeks

  • insulin resistance

    8 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

receive diet health advises.

Interventions

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

experimental group

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \) 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.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

ObesityAtherosclerosis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marwa elsayed, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

November 1, 2023

Primary Completion

December 30, 2024

Study Completion

January 30, 2025

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

journal publishing article

Shared Documents
STUDY PROTOCOL
Time Frame
after 4 years of publishing
Access Criteria
publishing journal web site

Locations