How physical activity, fatigue, social support, and mental well-being are linked in women with primary hypothyroidism
Physical Activity, Fatigue, Social Support, and Psychological Well-Being in Women With Primary Hypothyroidism: A Multicenter Observational Cohort Study
This project will see if physical activity levels are linked with fatigue, social support, and psychological well-being in adult women with primary hypothyroidism.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Oviedo Academic / other |
| Locations | 1 site (Oviedo, Principality of Asturias) |
| Trial ID | NCT07408765 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adult women (≥18 years) with confirmed primary hypothyroidism (clinical or subclinical) on a stable treatment plan who can walk independently and complete questionnaires are ideal candidates.
Not a fit: Women with severe comorbid conditions that independently limit physical activity, severe psychiatric illness, or those who cannot ambulate or complete questionnaires are unlikely to gain benefit from participation.
Why it matters
Potential benefit: If clear links are found, the results could point to targeted strategies—such as increasing activity or strengthening social support—to reduce fatigue and improve mental well-being in these women.
How similar studies have performed: Previous research on the links between activity, fatigue, and psychological well-being in hypothyroid women is limited and methodologically heterogeneous, yielding mixed and inconclusive results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Oviedo, Principality of Asturias
- Universidad de Oviedo — Oviedo, Principality of Asturias, Spain (Recruiting)
Study contacts
- Study coordinator: Rubén Cuesta-Barriuso, PhD
- Email: cuestaruben@uniovi.es
- Phone: 0034 985103386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.