- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06610955
Comparison of Two Different Intensity Exercises on Young Women With Obesity
February 3, 2025 updated by: Figen Tuncay, Ahi Evran University Education and Research Hospital
Effects of High Intensity Interval Training vs. Moderate Intensity Continuous Training on Fat Loss,Serum Adiponectin,Leptin,Omentin Level,Sleep and Quality of Life in Young Females With Obesity
Obesity is one of the most common preventable public health problems.
Diet regulation and exercise practices are the most commonly used methods in reducing fat tissue.
There are various exercise methods applied in the weight loss process and the effects of different types of exercise modalities on body fat rate and metabolic status.The aim of our study is to determine the effects of high intensity interval exercise and moderate intensity continuous exercise on serum , omentin, leptin and adiponectin levels, anthropometric measurements used in obesity follow up, body fat percentage and their effects on the quality of sleep and life of women with obesity.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Female participants aged 18-45 with a body mass index of 30-40 kg/m² who met the inclusion and exclusion criteria were randomized into two groups using a simple randomization method using a computer.
One group will perform high intensity interval exercise with an Ergoline bicycle ergometry device for 45 minutes a day, 5 days a week for 8 weeks, while the other group will perform moderate intensity continuous exercise on the same device.
Peripheral venous blood samples will be taken from all participants at the beginning and end of the study, anthropometric measurements used in obesity monitoring of all participants will be taken and noted, and participants will be asked to fill out questionnaires containing questions about their sleep and quality of life.
The analysis of the blood samples taken will be carried out in the Biochemistry Laboratory of Kırşehir Ahi Evran University.
The data of our study will be analyzed with the statistical package program SPSS version 23.0.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Figen Tuncay, Professor
- Phone Number: +90 5353046401
- Email: figentuncay3206@hotmail.com
Study Contact Backup
- Name: Elif Kapaklı, RA
- Phone Number: +90 5432139966
- Email: elifkapakli@gmail.com
Study Locations
-
-
-
Kırşehir, Turkey, 40100
- Recruiting
- Kırşehir Ahi Evran Üniversitesi
-
Contact:
- Figen Tuncay, Prof.Dr.
- Phone Number: +90 5353046401
- Email: figentuncay3206@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Female between the age of 18-45
- BMI 30-40 kg/m²
- Primary obesity
Exclusion Criteria:
- Patients with cardiac, pulmonary, endocrinological, rheumatological diseases
- Pregnancy and breastfeeding
- Using antipsychotics, antidepressants (lithium, tricyclic antidepressants, mono amino oxidase inhibitors), anticonvulsants, antihistamines, glucocorticoids, antidiabetics (sulfonylureas, insulins, glitazones) sex hormones
- Using oral contraceptives
- History of bariatric surgery
- Patients using obesity medication in the last 6 months, complying with a regular diet and exercise program
- Presence of orthopedic or neurological problems that difficulty of participate aerobic exercise training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: High intensity interval training exercise group
After a 10 minutes warm up exercise, participants will exercise with a bicycle ergometry device at 80% of their maximum heart rate for 4 minutes, and the active recovery period will be 3 minutes (4x4 minutes).
During the recovery period, the participant will exercise with the Ergoline bicycle ergometry system for 4 sets at 60% of their maximum heart rate for 3 minutes.
A total of 45 minutes exercise session will be completed with a 10 minutes cool down exercise.
Exercise will be done 5 days a week for a total of 8 weeks.
In the first 4 weeks, exercise will be done at 80% intensity, and in the following weeks, the exercise intensity will be increased by 5% each week, respectively, to 85%, 90%, 95%, and 100% in the last week.
|
After a 10 minutes warm up exercise, participants will exercise with a bicycle ergometry device at 80% of their maximum heart rate for 4 minutes, and the active recovery period will be 3 minutes (4x4 minutes).
During the recovery period, the participant will exercise with the Ergoline bicycle ergometry system for 4 sets at 60% of their maximum heart rate for 3 minutes.
A total of 45 minutes exercise session will be completed with a 10 minutes cool down exercise.
Exercise will be done 5 days a week for a total of 8 weeks.
In the first 4 weeks, exercise will be done at 80% intensity, and in the following weeks, the exercise intensity will be increased by 5% each week, respectively, to 85%, 90%, 95%, and 100% in the last week.
|
|
Active Comparator: Moderate intensity continuous exercise group
Following a 10 minutes warm up exercise, participants will exercise continuously for 30 minutes at 65% of their maximum heart rate with the Ergoline bicycle ergometry system.
A 5 minutes cool down exercise will end the 45 minutes exercise session.
The exercise duration is 5 days a week for a total of 8 weeks.
|
Following a 10 minutes warm up exercise, participants will exercise continuously for 30 minutes at 65% of their maximum heart rate with the Ergoline bicycle ergometry system.
A 5 minutes cool down exercise will end the 45 minutes exercise session.
The exercise duration is 5 days a week for a total of 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum adipokine levels
Time Frame: 8 weeks
|
This study aimed to investigate the effects of high intensity interval exercise and moderate intensity continuous exercise on serum adiponectin, leptin and omentin levels in young women with obesity.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometric measurement
Time Frame: 8 weeks
|
waist and hip circumference measurements
|
8 weeks
|
|
Percentage of body fat
Time Frame: 8 weeks
|
skinfold thickness will measure with skinfold caliper
|
8 weeks
|
|
Quality of sleep
Time Frame: 8 weeks
|
Sleep quality will describe Pittsburgh sleep quality index
|
8 weeks
|
|
The impact of weight on quality of life
Time Frame: 8 weeks
|
The impact of weight on quality of life will describe with The Impact of Weight on Quality of Life-Lite index
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Figen Tuncay, Professor, Ahi Evran Univeristy
- Study Chair: Elif Kapaklı, RA, Kirsehir Ahi Evran Universitesi
- Study Chair: Gamze Turna Saltoğlu, Ass. Prof., Kirsehir Ahi Evran Universitesi
- Study Chair: Başak Çiğdem Karaçay, Assoc. Prof., Kirsehir Ahi Evran Universitesi
- Study Chair: Nazife Kapan, Ass. Prof., Kirsehir Ahi Evran Universitesi
- Study Chair: Başak Kavalcı Kol, Ass. Prof., Kirsehir Ahi Evran Universitesi
- Study Chair: Merve Fırat, Ass. Prof., Kirsehir Ahi Evran Universitesi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 18, 2024
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
September 15, 2024
First Submitted That Met QC Criteria
September 22, 2024
First Posted (Actual)
September 24, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 3, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEU-FTR-EK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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