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

Physical Activity, Fatigue, Social Support, and Psychological Well-Being in Women With Primary Hypothyroidism: A Multicenter Observational Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hypothyroidism Primary
• Intervention / Treatment: Other: Women with primary hypothyroidism sample

• Study Type: Observational
• Enrollment (Estimated): 96

Contacts and Locations

• Study Contact: Name: Rubén Cuesta-Barriuso, PhD; Phone Number: 0034 985103386; Email: cuestaruben@uniovi.es
• Study Contact Backup: Name: Rubén Cuesta-Barriuso, PhD; Email: cuestaruben@uniovi.es

Study Locations

• Spain
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33006
      • Recruiting
      • Universidad de Oviedo
      • Contact: Rubén Cuesta-Barriuso; Phone Number: 607547274; Email: cuestaruben@uniovi.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with primary hypothyroidism

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational group; Women with primary hypothyroidism from the Principality of Asturias	Other: Women with primary hypothyroidism sample; To assess the level of physical activity in women with primary hypothyroidism and to identify the predictive model of physical activity in this population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of habitual physical activity level	This variable will be assessed using the Spanish version of the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This instrument, widely used in clinical and population-based research, allows estimation of weekly energy expenditure in MET-minutes and classification of participants into low, moderate, or high physical activity categories.	Screening visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of perceived fatigue	This variable will be assessed using the Spanish-validated Fatigue Severity Scale (FSS). The FSS is one of the most widely used instruments internationally to measure physical and mental fatigue in chronic conditions and consists of nine items rated on a 1-7 scale.	Screening visit
Measurement of perceived social support	This variable will be assessed using the Spanish version of the Medical Outcomes Study Social Support Survey (MOS-SSS). This 19-item questionnaire evaluates four dimensions of support (emotional/informational, instrumental, affectionate, and positive social interaction).	Screening visit
Measurement of psychological well-being	This variable will be assessed using the Spanish version of the WHO-5 Well-Being Index. This five-item instrument evaluates subjective well-being over the previous two weeks and its use in research is recommended by the World Health Organization.	Screening visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of age	This potential confounding or moderating variable, which may influence the relationship between physical activity and psychosocial factors, will be assessed in years.	Screening visit
Measurement of body mass index	This potential confounding or moderating variable, which may influence the relationship between physical activity and psychosocial factors, will be calculated from body mass and height (kg/m²).	Screening visit
Measurement of type of hypothyroidism	This potential confounding or moderating variable, which may influence the relationship between physical activity and psychosocial factors, will be classified as clinical or subclinical primary hypothyroidism based on TSH and FT4 levels.	Screening visit
Measurement of time since diagnosis	This potential confounding or moderating variable, which may influence the relationship between physical activity and psychosocial factors, will be assessed in years.	Screening visit

Collaborators and Investigators

• Sponsor: University of Oviedo

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): April 28, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Hypothyroidism; Physical activity; Physiotherapy; Female
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Behavior; Hypothyroidism; Motor Activity
• Other Study ID Numbers: HipotAct

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No