How physical activity, fatigue, social support, and mental well-being are linked in women with primary hypothyroidism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, analytical multicenter cohort including 96 adult women with primary (clinical or subclinical) hypothyroidism recruited from the Principality of Asturias. Physical activity will be measured with the International Physical Activity Questionnaire-Short Form (IPAQ-SF), and validated questionnaires will be used to quantify fatigue, social support, and psychological well-being. Profiles will be compared between clinical and subclinical hypothyroidism and the study will explore whether social support and psychological well-being modify the relationship between fatigue and activity. Participants must have a stable thyroid treatment regimen or stable clinical status and be able to ambulate and complete questionnaires independently.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have a diagnosis of primary hypothyroidism (clinical or subclinical), established by a specialist in Endocrinology or Internal Medicine based on TSH and FT4 levels.
* Female.
* Are aged ≥18 years at the time of inclusion.
* Have stable treatment for thyroid dysfunction (levothyroxine dose or other replacement regimen without relevant modifications) for at least the previous 3 months, or a stable clinical condition if treatment is not required.
* Are able to ambulate independently in the community (with or without usual assistive devices), allowing participation in light to moderate physical activity.
* Are able to understand and complete the questionnaires independently.
* Have provided written informed consent

Exclusion Criteria:

* Have a diagnosis of severe medical conditions that predominantly limit the ability to perform physical activity independently of hypothyroidism (e.g., advanced heart failure, severe chronic respiratory disease).
* Have severe psychiatric disorders or significant cognitive impairment that hinder understanding of the information or reliable completion of the questionnaires.
* Have undergone major surgery, severe trauma, or an acute medical condition that has substantially limited physical activity in the three months prior to assessment.
* Are pregnant or in the immediate postpartum period, due to potential hormonal and functional interference with the study variables.
* Are concurrently participating in a clinical trial or a structured physical exercise program.

Where it's running

• Universidad de Oviedo
  Oviedo, Principality of Asturias, Spain Recruiting

Study contacts

• Study coordinator: Rubén Cuesta-Barriuso, PhD
• Email: cuestaruben@uniovi.es
• Phone: 0034 985103386

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.