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

A legfontosabb adatok

Ki végzi
University of Oviedo
Hol
Spanyolország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
96 fő, tervezett
Kezdés
2026. febr. 16.
Tervezett befejezés
2026. máj. 15.
A vizsgálat típusa
Megfigyeléses
A vizsgált kezelések
  • Women with primary hypothyroidism sample
A regiszteradat frissítve
2026. február 19.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adult women with primary hypothyroidism (an underactive thyroid), clinical or subclinical. It studies physical activity, tiredness, social support and well-being through questionnaires.

Életkor
18 years and older.
Nem
Women only.
A betegség stádiuma
Primary hypothyroidism, clinical or subclinical, diagnosed by a hormone (Endocrinology) or Internal Medicine specialist. People must be able to walk on their own in the community, with or without their usual walking aids.
Korábbi kezelés
Thyroid treatment (such as levothyroxine) must have been stable, with no relevant changes, for at least the previous 3 months. If no treatment is needed, the condition must be stable.
Biomarker vagy leletérték
Diagnosis based on TSH and FT4 blood levels.

A részvétel fő kizáró okai

  • Severe illness that limits physical activity, such as advanced heart failure or severe chronic lung disease.
  • Severe mental illness or major memory or thinking problems that make the questionnaires hard to complete.
  • Major surgery, severe injury or sudden illness that greatly limited activity in the last 3 months.
  • Pregnancy or having just given birth.
  • Taking part in another clinical trial or a structured exercise program.

A regiszter feltételei, szó szerint

Mind a 12 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • Have undergone major surgery, severe trauma, or an acute medical condition that has substantially limited physical activity in the three months prior to assessment
  • 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
  • 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

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat csoportja

  • Observational group

    Women with primary hypothyroidism from the Principality of Asturias

    Kezelés: Women with primary hypothyroidism sample

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Physical Activity, Fatigue, Social Support, and Psychological Well-Being in Women With Primary Hypothyroidism: A Multicenter Observational Cohort Study
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
A regiszteradat frissítve
2026. február 19.