- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06793345
Walking Training Improves Thyroid and Cardiometabolic Markers in Postmenopausal Obesity
Moderate Intensity Intermittent Walking Training (MIWT) Improves Thyroid Function and Cardiometabolic Risk Factors in Obese Postmenopausal Women
The goal of this clinical trial is to investigate the impact of a 10-week MIWT program on thyroid hormone levels and key cardiometabolic markers in obese postmenopausal women. The main question it aims to answer is:
Does MIWT enhance thyroid function and reduce cardiometabolic risk factors in this population? Researchers will compare MIWT (designed to MIWT group) to non-training intervention (designed to control group) to see if the training program works to improve thyroid function and cardiometabolic risk factors.
Participants in MIWT group will: perform a 10-week MIWT program, four sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions).
Participants in control group will : not perform any physical training and maintain their usual daily activities.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kef
-
Boulifa, Kef, Tunisia, 7100
- High Institute of Sports and Physical Education of Kef
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Body mass index≥ 30 kg.m-2.
- Age between 50 and 60.
- Amenorrhea for >12 months.
- Stable eating habits.
Exclusion Criteria:
- Chronic diseases.
- Medical contraindications to physical activity.
- Hormone replacement therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MIWT group
The MIWT group received moderate intensity intermittent walking training four times per week for 10 weeks.
|
The intensity of the training is 60 to 80% of 6MWTdistance.
|
|
No Intervention: Control group
The control group received no intervention for 10 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thyroid hormones
Time Frame: At baseline and after ten weeks of MIWT.
|
Serum thyroid hormone concentrations are measured from a blood sample (5 ml) obtained from a prominent superficial vein in the antecubital region.
|
At baseline and after ten weeks of MIWT.
|
|
Body composition
Time Frame: At baseline and after ten weeks of MIWT.
|
Body composition was assessed using an electronic scale (Tanita BC-533, Tokyo, Japan),
|
At baseline and after ten weeks of MIWT.
|
|
Lipid profile
Time Frame: At baseline and after ten weeks of MIWT.
|
Measured by blood samples (5ml) from a prominent superficial vein in the antecubital region.
|
At baseline and after ten weeks of MIWT.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic and diastolic blood pressure
Time Frame: At baseline and after ten weeks of MIWT.
|
Systolic and diastolic blood pressure measurements were conducted using an automatic blood pressure monitor (Omron BP652, Omron Healthcare Inc., Vernon Hills, IL, USA).
|
At baseline and after ten weeks of MIWT.
|
|
Heart rate
Time Frame: At baseline and after ten weeks of MIWT
|
Heart rate was recorded after 10 minutes of relaxation in a seated position using an automatic blood pressure monitor (Omron BP652, Omron Healthcare Inc., Vernon Hills, IL, USA).
|
At baseline and after ten weeks of MIWT
|
|
6 min walking test distance
Time Frame: At baseline and after ten weeks of MIWT
|
It was recorded using the 6 min walking test.
|
At baseline and after ten weeks of MIWT
|
|
Perceived exertion rating
Time Frame: At baseline and after ten weeks of MIWT.
|
Perceived exertion rating (RPE) was assessed with the extensively validated RPE, a 15-point scale ranging from 6 ("no exertion at all") to 20 ("maximal exertion").
|
At baseline and after ten weeks of MIWT.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Training and thyroid function
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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