- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07263126
Effect of Bicycle Ergometer Training on Fat Tissue Amount and Metabolism
May 10, 2026 updated by: Şule ŞİMŞEK, Pamukkale University
Effect of Bicycle Ergometer Training in Thermoneutral and Lightly Cold Ambient Temperatures on Fat Tissue Amount and Metabolism in Overweight and Obese Women
The aim of this study is to investigate the effect of endurance training performed with a bicycle ergometer at different ambient temperatures on the amount of fat tissue and fat tissue metabolism in overweight and obese women.
Study Overview
Status
Completed
Conditions
Detailed Description
This study will examine the effects of 12 weeks of endurance training on a bicycle ergometer at thermoneutral and slightly cold ambient temperatures on body composition, subcutaneous and visceral fat tissue thickness, and levels of irisin, leptin, adiponectin, apelin, IL-6 and FGF-21 in the blood of overweight and obese women.
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
-
-
Sarayköy
-
Denizli, Sarayköy, Turkey (Türkiye), 09200
- Şule Şimşek
-
-
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
Yes
Description
Inclusion Criteria:
Being female,
- Being between 20-40 years old,
- Having a BMI between 25 and 34.9,
- Having a waist circumference greater than 80 cm,
- Not having participated in any exercise program in the last 3 months ,
- Not having experienced a change of more than 10% in body weight in the last 6 months.
Exclusion Criteria:
On a weight loss diet,
- Having cancer, unstable heart disease, cerebrovascular disease, metabolic disease, diabetes, hypertension, psychiatric disorders, or other conditions or neurological disorders,
- Having a musculoskeletal disorder or any disease/injury that may affect participation in exercise training,
- Participating in regular physical activity (at least 150 minutes of moderate-intensity physical activity or 75 minutes of vigorous-intensity physical activity or an equivalent combination of both during the week),
- Being pregnant or breastfeeding,
- Having undergone surgery for the treatment of obesity,
- Receiving pharmacological treatment for obesity. Participants who did not attend more than 20% of the endurance training program will be excluded from the study.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Case group 1
participants trained in termoneutral ambient temperature
|
trained with bicycle ergometer three times a week for three months.
|
|
Active Comparator: Case group 2
participants trained in lightly cold ambient temperature
|
trained with bicycle ergometer three times a week for three months.
|
|
No Intervention: control group
participants do not trained
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of BMI
Time Frame: baseline/ through study completion, an average 3 months
|
assesed with height and body weight
|
baseline/ through study completion, an average 3 months
|
|
analysis of biyoelectric impedans Bioelectrical impedance analysis
Time Frame: baseline/ through study completion, an average 3 months
|
assesed with with a Tanita BC 418 brand device.
|
baseline/ through study completion, an average 3 months
|
|
Ratio of waist-hip Waist hip ratio
Time Frame: baseline/ through study completion, an average 3 months
|
Waist and hip circumference will be measured with a tape measure.
|
baseline/ through study completion, an average 3 months
|
|
rate of subcutaneous and visceral adipose tissue thickness
Time Frame: baseline/ through study completion, an average 3 months
|
assesed with Ultrasonography
|
baseline/ through study completion, an average 3 months
|
|
concentration of serum irisin, leptin, adiponectin, apelin, İL-6 and FGF-21
Time Frame: baseline/ through study completion, an average 3 months
|
assesed with blood analysis
|
baseline/ through study completion, an average 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ummuhan Baş Aslan, Prof. Dr., Prof. Dr.
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)
May 27, 2025
Primary Completion (Actual)
September 27, 2025
Study Completion (Actual)
April 27, 2026
Study Registration Dates
First Submitted
May 27, 2025
First Submitted That Met QC Criteria
December 3, 2025
First Posted (Actual)
December 4, 2025
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 10, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Endurance Training
Other Study ID Numbers
- 23.07.2024/13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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