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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Kırşehir, Turkey, 40100
        • Recruiting
        • Kırşehir Ahi Evran Üniversitesi
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: High intensity interval training
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.
Other: Moderate intensity continuous training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahi Evran University Education and Research Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kirsehir Ahi Evran Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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