- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509464
Response Of Metabolic Syndrome Severity Score To High Intenisty Interval Training In Women With Central Obesity.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
RESPONSE OF METABOLIC SYNDROME SEVERITY SCORE TO HIGH INTENISTY INTERVAL TRAINING IN WOMEN WITH CENTRAL OBESITY
forty eight women with age ranges from 25 to 45 years old will be selected from nutrition-outpatient clinic; they will participate in the study for 6 weeks, and randomly be assigned into two equal groups.
Study group A (n =24) will receive low volume High-intensity interval training (HIIT) three times /week for 6 weeks , study group B (n =24) will receive caloric restriction diet
For evaluation Physical efficiency index using Modified Harvard Step test It is a powerful indicator for aerobic fitness. The Fitness Index score is determined according to the following equation
Fitness Index (long form) = (100 x test duration in seconds) divided by (2 x sum of heart beats in the recovery periods).
Metabolic syndrome severity score Metabolic syndrome severity score will be calculated through MetS Calculator (MetSCalc).
-3Laboratory investigation before & after treatment: for fasting blood glucose level and Lipid profile (total cholesterol, LDL, HDL, TAGs).
4- The 45-item Diet Satisfaction Questionnaire (DSat-45)
B) For treatment
1- Grand II Treadmill: (AC999- for maximum weight 150 Kg-
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Soma Adel Abd El-Ghany, Master degree
- Phone Number: 002 0106 196 2553
- Email: Somaadelxp123@gmail.com
Study Contact Backup
- Name: Hanan Mohamed, Bsc
- Phone Number: 02 01151312322
- Email: eth.com@pt.cu.edu.eg
Study Locations
-
-
-
Giza, Egypt, 12611
- Recruiting
- Faculty of Physical Therapy Cairo University
-
Contact:
- Hanan Mohamed, BSc
- Phone Number: 002 01151312322
- Email: eth.com@pt.cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. 48 Women subjects with age ranges from 25to 45 years.
2. Waist height ratio ranges from 49-58 (overweight and seriously overweight).
Exclusion Criteria:
- 1. 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: low volume High-intensity interval training (HIIT)
group A (n =24) will receive low volume High-intensity interval training (HIIT) three times /week for 3 months,
|
High intensity interval training on treadmill
Caloric restricted diet
|
|
Experimental: caloric restricted diet.
group B (24) will receive caloric restricted diet.
|
High intensity interval training on treadmill
Caloric restricted diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Metabolic syndrome severity score
Time Frame: 6weeks
|
6weeks
|
|
Physical efficiency index using Modified Harvard Step test
Time Frame: 6weeks
|
6weeks
|
|
The 45-item Diet Satisfaction Questionnaire (DSat-45
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nesreen Ghareeb Elnahas, Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cairo soma 46
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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