Walking Training Improves Thyroid and Cardiometabolic Markers in Postmenopausal Obesity

January 23, 2025 updated by: Wissal Abassi

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

Detailed Description

This study aimed to investigate the impact of a 10-week MIWT program on thyroid hormone levels and key cardiometabolic markers in obese postmenopausal women. Thirty-six obese postmenopausal women (BMI≥30 kg.m-2, aged 50-60 yrs.) were randomized to either a moderate-intensity intermittent walking training (MIWT) group (n=18) or control group (CG, n=18). Participants performed 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). Body composition, thyroid hormones (thyroid stimulating hormone (TSH) and thyroxine free (FT4)), lipid profile (triglycerides (TRG), total cholesterol(TC), high-density lipoprotein cholesterol(HDLC) and low-density lipoprotein cholesterol(LDLC)), blood pressure (systolic and diastolic blood pressure) and aerobic fitness (6MWT) were determined before and after the MIWT.

Study Type

Interventional

Enrollment (Actual)

36

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

    • Kef
      • Boulifa, Kef, Tunisia, 7100
        • High Institute of Sports and Physical Education of Kef

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:

  • 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

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: 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

This is where you will find people and organizations involved with this study.

Sponsor

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)

September 23, 2024

Primary Completion (Actual)

December 22, 2024

Study Completion (Actual)

December 22, 2024

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For confidentiality reasons, all data from this study are available upon request.

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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