Hypothyroidism PrimaryNCT07408765
Physical Activity, Fatigue, Social Support, and Psychological Well-Being in Women With Primary Hypothyroidism
An observational study of Hypothyroidism Primary, run by University of Oviedo at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypothyroidism Primary
- What is being tested?
- Women with primary hypothyroidism sample
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2026to 15 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with primary hypothyroidism
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rubén Cuesta-Barriuso, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Universidad de Oviedo
Oviedo, Principality of Asturias, 33006
Rubén Cuesta-Barriuso, 607547274, cuestaruben@uniovi.es
About this study
Official title: 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.
Read more
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
- Hypothyroidism Primary
- Being tested
- Women with primary hypothyroidism sample
- Keywords
- Female, Hypothyroidism, Physical activity, Physiotherapy
- Medical subject headings
- Hypothyroidism, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women with primary hypothyroidism sampleOther
To assess the level of physical activity in women with primary hypothyroidism and to identify the predictive model of physical activity in this population.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Women with primary hypothyroidism from the Principality of Asturias Receives: Other: Women with primary hypothyroidism sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening visit
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start16 Feb 2026
- Primary completion28 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothyroidism PrimaryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Cuesta Barriuso, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408765
- Sponsor's protocol ID
- HipotAct
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Fatigue, Social Support, and Psychological Well-Being in Women With Primary Hypothyroidism: A Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07408765
- Acronym / sponsor ID
- HipotAct
- Conditions
- Hypothyroidism Primary
- Keywords
- Female, Hypothyroidism, Physical activity, Physiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 28 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 13 Feb 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Women with primary hypothyroidism sampleWomen with primary hypothyroidism from the Principality of Asturias |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with primary hypothyroidism
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Women with primary hypothyroidism sampleTo assess the level of physical activity in women with primary hypothyroidism and to identify the predictive model of physical activity in this population. | Other | Observational group |
Primary outcome
Measurement of habitual physical activity level
Time frame: Screening visit
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.
3 secondary outcomes
Measurement of perceived fatigue
Time frame: Screening visit
Measurement of perceived social support
Time frame: Screening visit
Measurement of psychological well-being
Time frame: Screening visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Rubén Cuesta-Barriuso, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism Primary, run by University of Oviedo at 1 site in Spain.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Feb 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rubén Cuesta-Barriuso, PhD (0034 985103386, cuestaruben@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of habitual physical activity level (time frame: Screening visit). 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 19 Feb 2026.