NCT06509464

Brief Summary

This study will be conducted to investigate any significant effect of high intensity interval training on metabolic syndrome severity score in women with central obesity.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

July 9, 2024

Last Update Submit

April 6, 2025

Conditions

Metabolic Syndrom

Keywords

Metabolic syndrom severity scoreMetabolic syndromCentral obesity

Outcome Measures

Primary Outcomes (3)

  • Metabolic syndrome severity score

    6weeks

  • Physical efficiency index using Modified Harvard Step test

    6weeks

  • The 45-item Diet Satisfaction Questionnaire (DSat-45

    6 weeks

Study Arms (2)

low volume High-intensity interval training (HIIT)

EXPERIMENTAL

group A (n =24) will receive low volume High-intensity interval training (HIIT) three times /week for 3 months,

Device: High intensity interval trainingDietary Supplement: Caloric restricted diet

caloric restricted diet.

EXPERIMENTAL

group B (24) will receive caloric restricted diet.

Device: High intensity interval trainingDietary Supplement: Caloric restricted diet

Interventions

High intensity interval trainingDEVICE

High intensity interval training on treadmill

caloric restricted diet.low volume High-intensity interval training (HIIT)
Caloric restricted dietDIETARY_SUPPLEMENT

Caloric restricted diet

caloric restricted diet.low volume High-intensity interval training (HIIT)

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 1. 48 Women subjects with age ranges from 25to 45 years.
  • \. Waist height ratio ranges from 49-58 (overweight and seriously overweight).

You may not qualify if:

  • \. Uncontrolled Diabetes 2. Uncontrolled hypertension 3. Cognitive impaired patients 4. Severe Anemic women 5. Subjects with physical or musculoskeletal disabilities 6. Pregnancy 7. Recent cardiothoracic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy cairo university

Giza, 12611, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Nesreen Ghareeb Elnahas, Professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soma Adel Abd El-Ghany, Master degree

CONTACT

0106 196 2553Somaadelxp123@gmail.com

Hanan Mohamed, Bsc

CONTACT

01151312322eth.com@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 19, 2024

Study Start

December 20, 2024

Primary Completion

May 30, 2025

Study Completion

June 15, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations

EG(1)