Actively Recruiting

Age: 18Years +
FEMALE
NCT07408765

Physical Activity, Fatigue, Social Support, and Psychological Well-Being in Women With Primary Hypothyroidism

Led by University of Oviedo · Updated on 2026-02-19

96

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background. Primary hypothyroidism, both clinical and subclinical, is frequently associated with persistent fatigue, reduced psychological well-being, and lower levels of physical activity in adult women. However, evidence integrating these psychosocial factors remains limited and methodologically heterogeneous. Objective. To analyze the association between physical activity and fatigue, social support, and psychological well-being in women with primary hypothyroidism; to compare these profiles between clinical and subclinical hypothyroidism; and to explore the moderating effect of social support and psychological well-being on the relationship between fatigue and physical activity. Methods. An observational, analytical, multicenter cohort study will be conducted including 96 adult women with primary hypothyroidism from the Principality of Asturias. Physical activity levels will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), while fatigue, social support, and psychological well-being will be measured using the Fatigue Severity Scale (FSS), the Medical Outcomes Study Social Support Survey (MOS-SSS), and the WHO-5 Well-Being Index, respectively. Confounding variables will include age, body mass index, type of hypothyroidism (clinical or subclinical), and time since diagnosis. Descriptive analyses, comparisons between clinical and subclinical groups, and multiple linear regression models will be performed. Expected results. The study is expected to identify physical activity levels within the sample and determine which psychosocial factors are independently associated with physical activity. Additionally, fatigue is anticipated to be negatively associated with physical activity, whereas social support and psychological well-being are expected to show positive associations and potential moderating effects.

CONDITIONS

Official Title

Physical Activity, Fatigue, Social Support, and Psychological Well-Being in Women With Primary Hypothyroidism

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of primary hypothyroidism (clinical or subclinical) confirmed by an Endocrinology or Internal Medicine specialist based on TSH and FT4 levels
  • Female gender
  • Age 18 years or older at inclusion
  • Stable thyroid treatment or stable clinical condition without treatment for at least 3 months
  • Ability to walk independently in the community, with or without assistive devices
  • Ability to understand and complete questionnaires independently
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Severe medical conditions that limit physical activity independently of hypothyroidism (e.g., advanced heart failure, severe chronic respiratory disease)
  • Severe psychiatric disorders or significant cognitive impairment preventing understanding or reliable questionnaire completion
  • Major surgery, severe trauma, or acute medical condition limiting physical activity in the past 3 months
  • Pregnancy or immediate postpartum period
  • Participation in another clinical trial or structured physical exercise program

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universidad de Oviedo

Oviedo, Principality of Asturias, Spain, 33006

Actively Recruiting

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Research Team

R

Rubén Cuesta-Barriuso, PhD

CONTACT

R

Rubén Cuesta-Barriuso, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Physical Activity, Fatigue, Social Support, and Psychological Well-Being in Women With Primary Hypothyroidism | DecenTrialz