Thyroid HormonesNCT06793345
Walking Training Improves Thyroid and Cardiometabolic Markers in Postmenopausal Obesity
A study testing Moderate intensity intermittent walking training in people with Thyroid Hormones and Cardiometabolic Risk Factors, run by Wissal Abassi at 1 site in Tunisia.
Trial 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?… Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Thyroid Hormones, Cardiometabolic Risk Factors
- What is being tested?
- Moderate intensity intermittent walking training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTunisia
- Study dates
- 23 Sep 2024to 22 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index≥ 30 kg.m-2.
- Age between 50 and 60.
- Amenorrhea for >12 months.
- Stable eating habits.
Who cannot join
- Chronic diseases.
- Medical contraindications to physical activity.
- Hormone replacement therapy.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
High Institute of Sports and Physical Education of Kef
Boulifa, Kef Governorate, 7100
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Thyroid Hormones, Cardiometabolic Risk Factors
- Being tested
- Moderate intensity intermittent walking training
- Keywords
- Thyroid hormones, Lipid profile, Obesity, Blood pressure, Moderate intensity intermittent walking training, Body composition
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity intermittent walking trainingOther
The intensity of the training is 60 to 80% of 6MWTdistance.
| Study group | Role | What they receive |
|---|---|---|
| MIWT group | Experimental | The MIWT group received moderate intensity intermittent walking training four times per week for 10 weeks. Receives: Other: Moderate intensity intermittent walking training |
| Control group | No intervention | The control group received no intervention for 10 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid hormones
Serum thyroid hormone concentrations are measured from a blood sample (5 ml) obtained from a prominent superficial vein in the antecubital region.
Measured: At baseline and after ten weeks of MIWT.
Body composition
Body composition was assessed using an electronic scale (Tanita BC-533, Tokyo, Japan),
Measured: At baseline and after ten weeks of MIWT.
Lipid profile
Measured by blood samples (5ml) from a prominent superficial vein in the antecubital region.
Measured: At baseline and after ten weeks of MIWT.
Secondary outcomes (4)
Systolic and diastolic blood pressure
Systolic and diastolic blood pressure measurements were conducted using an automatic blood pressure monitor (Omron BP652, Omron Healthcare Inc., Vernon Hills, IL, USA).
Measured: At baseline and after ten weeks of MIWT.
Heart rate
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).
Measured: At baseline and after ten weeks of MIWT
6 min walking test distance
It was recorded using the 6 min walking test.
Measured: At baseline and after ten weeks of MIWT
Perceived exertion rating
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").
Measured: At baseline and after ten weeks of MIWT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start23 Sep 2024
- Primary completion22 Dec 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid HormonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissal Abassi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wissal Abassi, High Institute of Sports and Physical Education of Kef
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793345
- Sponsor's protocol ID
- Training and thyroid function
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality reasons, all data from this study are available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Intensity Intermittent Walking Training (MIWT) Improves Thyroid Function and Cardiometabolic Risk Factors in Obese Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06793345
- Acronym / sponsor ID
- Training and thyroid function
- Conditions
- Thyroid Hormones, Cardiometabolic Risk Factors
- Keywords
- Thyroid hormones, Lipid profile, Obesity, Blood pressure, Moderate intensity intermittent walking training, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Wissal AbassiUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIWT group | Experimental | Other: Moderate intensity intermittent walking trainingThe MIWT group received moderate intensity intermittent walking training four times per week for 10 weeks. |
| Control group | No intervention | –The control group received no intervention for 10 weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index≥ 30 kg.m-2.
- Age between 50 and 60.
- Amenorrhea for >12 months.
- Stable eating habits.
Key exclusion criteria (3 listed)
- Chronic diseases.
- Medical contraindications to physical activity.
- Hormone replacement therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity intermittent walking trainingThe intensity of the training is 60 to 80% of 6MWTdistance. | Other | MIWT group |
Primary outcome
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.
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),
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.
4 secondary outcomes
Systolic and diastolic blood pressure
Time frame: At baseline and after ten weeks of MIWT.
Heart rate
Time frame: At baseline and after ten weeks of MIWT
6 min walking test distance
Time frame: At baseline and after ten weeks of MIWT
Perceived exertion rating
Time frame: At baseline and after ten weeks of MIWT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No. For confidentiality reasons, all data from this study are available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity intermittent walking training in people with Thyroid Hormones and Cardiometabolic Risk Factors, run by Wissal Abassi at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid hormones (time frame: At baseline and after ten weeks of MIWT.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.