NCT06793345

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 18, 2025

Last Update Submit

January 23, 2025

Conditions

Keywords

Thyroid hormonesLipid profileObesityBlood pressureModerate intensity intermittent walking trainingBody composition

Outcome Measures

Primary Outcomes (3)

  • Thyroid hormones

    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

    Body composition was assessed using an electronic scale (Tanita BC-533, Tokyo, Japan),

    At baseline and after ten weeks of MIWT.

  • Lipid profile

    Measured by blood samples (5ml) from a prominent superficial vein in the antecubital region.

    At baseline and after ten weeks of MIWT.

Secondary Outcomes (4)

  • Systolic and diastolic blood pressure

    At baseline and after ten weeks of MIWT.

  • Heart rate

    At baseline and after ten weeks of MIWT

  • 6 min walking test distance

    At baseline and after ten weeks of MIWT

  • Perceived exertion rating

    At baseline and after ten weeks of MIWT.

Study Arms (2)

MIWT group

EXPERIMENTAL

The MIWT group received moderate intensity intermittent walking training four times per week for 10 weeks.

Other: Moderate intensity intermittent walking training

Control group

NO INTERVENTION

The control group received no intervention for 10 weeks.

Interventions

The intensity of the training is 60 to 80% of 6MWTdistance.

MIWT group

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index≥ 30 kg.m-2.
  • Age between 50 and 60.
  • Amenorrhea for \>12 months.
  • Stable eating habits.

You may not qualify if:

  • Chronic diseases.
  • Medical contraindications to physical activity.
  • Hormone replacement therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

High Institute of Sports and Physical Education of Kef

Boulifa, Kef Governorate, 7100, Tunisia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2025

First Posted

January 27, 2025

Study Start

September 23, 2024

Primary Completion

December 22, 2024

Study Completion

December 22, 2024

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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

Locations