Exercise Self-Efficacy, Body Composition, and Physical Activity in Men With Hypogonadism
The Mediating Role of Exercise Self-Efficacy in the Relationship Between Body Composition and Physical Activity in Men With Hypogonadism: A Cross-Sectional Study
Male hypogonadism is a chronic endocrine condition characterized by deficient testosterone production, leading to adverse changes in body composition (decreased lean mass, increased fat mass) and various physical and psychological symptoms, including fatigue and reduced motivation. Although testosterone replacement therapy (TRT) is the primary medical treatment, its effectiveness in optimizing body composition largely depends on regular physical activity. However, the psychosocial mechanisms underlying exercise engagement in this specific population remain insufficiently explored.
Exercise self-efficacy, an individual's confidence in their ability to perform physical activity, is a major determinant of exercise behavior. While its mediating role between body composition and physical activity has been shown in other clinical populations, it has not been investigated in men with hypogonadism, where low testosterone levels uniquely impair psychological well-being and drive.
The primary objective of this cross-sectional study is to evaluate the mediating role of exercise self-efficacy in the relationship between body composition and physical activity levels in men with hypogonadism receiving TRT. Additionally, the study explores the potential moderating effects of serum total testosterone levels and TRT duration, while controlling for depressive symptoms as a covariate. Findings from this study aim to provide evidence-based guidance for clinicians and physical therapists in designing targeted exercise interventions and timing rehabilitation strategies for hypogonadal patients.
Přehled studie
Postavení
Detailní popis
Male hypogonadism is associated with adverse alterations in body composition, including reduced lean muscle mass and increased adiposity, alongside symptoms such as fatigue, dysphoric mood, and reduced motivation. Although testosterone replacement therapy (TRT) serves as the primary medical intervention, optimizing body composition outcomes relies significantly on concurrent physical activity.
Exercise self-efficacy, the confidence in one's capability to carry out physical activity, is a robust determinant of exercise adherence. In hypogonadism, low testosterone levels uniquely impair psychosocial well-being and motivational drive, creating a distinct biologically driven barrier to exercise engagement that differs from general metabolic or obesity-related populations.
Furthermore, the physiological and psychological responses to TRT follow a time-dependent trajectory. Early stages of therapy may exhibit rapid shifts in mood and sociability, whereas energy levels and physical capacity gradually improve over subsequent weeks and months. This temporal progression suggests that TRT duration and serum total testosterone levels may serve as critical moderators influencing how body composition interacts with exercise self-efficacy and physical activity.
This study evaluates the structural relationships between body composition parameters and physical activity levels in men with hypogonadism. Specifically, it tests whether exercise self-efficacy mediates this relationship, and assesses the potential moderating roles of serum total testosterone levels and TRT duration, while statistically controlling for depressive symptoms to isolate the specific biological and psychosocial pathways.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Emine Şener Aydın, MD
- Telefonní číslo: +904222118019
- E-mail: dreminesener@windowslive.com
Studijní místa
-
-
-
Bingoel, Turecko (Türkiye)
- Nábor
- Bingol University Faculty of Physical Therapy and Rehabilitation
-
Kontakt:
- Aybüke Fanuscu, Pt, PhD
- Telefonní číslo: 5548 +904262160012
- E-mail: afanuscu@bingol.edu.tr
-
Malatya, Turecko (Türkiye)
- Nábor
- Malatya Training and Research Hospital
-
Kontakt:
- Emine Şener Aydın, MD
- E-mail: dreminesener@windowslive.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
The study population consists of adult male patients aged 18 years or older who have been diagnosed with primary or secondary hypogonadism (biochemically confirmed morning serum total testosterone <300 ng/dL) and are currently receiving testosterone replacement therapy (TRT). Participants will be recruited from patients attending routine clinical visits at the Endocrinology Outpatient Clinic of Malatya Training and Research Hospital.
Popis
Inclusion Criteria:
- Confirmed diagnosis of male hypogonadism (primary or secondary; biochemically verified with a morning serum total testosterone level <300 ng/dL).
- Currently undergoing TRT with observed partial or complete symptom remission, evaluated as treatment-responsive by the clinician.
- Aged 18 years or older.
- Ability to read and write in Turkish.
- Voluntary agreement to participate and signature on the informed consent form.
Exclusion Criteria:
- Neurological, orthopedic, or cardiopulmonary conditions independent of hypogonadism that restrict physical activity capacity.
- Diagnosed psychiatric disorders directly impacting exercise self-efficacy and physical activity (e.g., major depressive disorder, psychosis).
- Concomitant endocrine disorders significantly affecting body composition, including uncontrolled or complicated diabetes mellitus (HbA1c >8.0% or presence of diabetic nephropathy, neuropathy, retinopathy) or biochemically unverified euthyroid state in thyroid disease.
- Presence of conditions preventing bioelectrical impedance analysis (e.g., implanted cardiac devices/pacemakers).
- Visual or cognitive impairments preventing the reading and completion of study questionnaires.
- Chronic inflammatory conditions directly affecting body composition and physical capacity (e.g., chronic kidney disease, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: OTHER
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
|---|
|
Men with Hypogonadism on TRT
Male patients aged 18 years or older who have been diagnosed with primary or secondary hypogonadism (biochemically verified morning serum total testosterone <300 ng/dL) and are currently receiving testosterone replacement therapy (TRT). |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Physical Activity Level
Časové okno: Baseline
|
Assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). IPAQ-SF evaluates walking, moderate, and vigorous intensity physical activities performed over the last 7 days. Total physical activity score will be calculated as MET-minutes/week. |
Baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Exercise Self-Efficacy Score
Časové okno: Baseline
|
Evaluated via the Exercise Self-Efficacy Scale (EXSE). The scale consists of 18 items assessing an individual's confidence to maintain exercise across challenging situations. Items are rated on a 0-100 numerical rating scale with 10-unit intervals. Total scores range from 0 to 1800, with higher scores reflecting greater confidence in exercise adherence. |
Baseline
|
|
Body Weight
Časové okno: Baseline
|
Measured using a Tanita BC-420SMA Bioelectrical Impedance Analyzer. This outcome reports body weight in kilograms. |
Baseline
|
|
Serum Total Testosterone Level
Časové okno: Baseline
|
Recorded from recent morning routine clinical laboratory records. Measured in nanograms per deciliter (ng/dL). |
Baseline
|
|
Depressive Symptoms (Covariate)
Časové okno: Baseline
|
Evaluated using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Contains 7 items, each scored on a 0-3 Likert scale (subscale score ranges from 0 to 21), with higher scores indicating higher levels of depressive symptoms. |
Baseline
|
|
Body Mass Index (BMI)
Časové okno: Baseline
|
Calculated using height and body weight via a Tanita BC-420SMA Bioelectrical Impedance Analyzer. |
Baseline
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Aybüke Fanuscu, Pt, PhD, Bingol University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AF-202603
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .