Universidad de Oviedo
Oviedo, Principality of Asturias, 33006, Spain
Location status: Recruiting
NCT Number: NCT07408765
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Oviedo, Principality of Asturias, 33006, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To assess the level of physical activity in women with primary hypothyroidism and to identify the predictive model of physical activity in this population.
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.
Time frame: Screening visit
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.
Time frame: Screening visit
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).
Time frame: Screening visit
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.
Time frame: Screening visit
This potential confounding or moderating variable, which may influence the relationship between physical activity and psychosocial factors, will be assessed in years.
Time frame: Screening visit
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).
Time frame: Screening visit
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.
Time frame: Screening visit
This potential confounding or moderating variable, which may influence the relationship between physical activity and psychosocial factors, will be assessed in years.
Contact information is provided by the study sponsor or research team.
Rubén Cuesta-Barriuso, PhD
CONTACT
Rubén Cuesta-Barriuso, PhD
CONTACT
University of Oviedo
Other
Physical Activity, Fatigue, Social Support, and Psychological Well-Being in Women With Primary Hypothyroidism: A Multicenter Observational Cohort Study
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