- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07924514
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Emine Şener Aydın, MD
- Numéro de téléphone: +904222118019
- E-mail: dreminesener@windowslive.com
Lieux d'étude
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Bingoel, Turquie (Türkiye)
- Recrutement
- Bingol University Faculty of Physical Therapy and Rehabilitation
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Contact:
- Aybüke Fanuscu, Pt, PhD
- Numéro de téléphone: 5548 +904262160012
- E-mail: afanuscu@bingol.edu.tr
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Malatya, Turquie (Türkiye)
- Recrutement
- Malatya Training and Research Hospital
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Contact:
- Emine Şener Aydın, MD
- E-mail: dreminesener@windowslive.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
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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). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Physical Activity Level
Délai: Baseline
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Exercise Self-Efficacy Score
Délai: Baseline
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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
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Body Weight
Délai: Baseline
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Measured using a Tanita BC-420SMA Bioelectrical Impedance Analyzer. This outcome reports body weight in kilograms. |
Baseline
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Serum Total Testosterone Level
Délai: Baseline
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Recorded from recent morning routine clinical laboratory records. Measured in nanograms per deciliter (ng/dL). |
Baseline
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Depressive Symptoms (Covariate)
Délai: Baseline
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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
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Body Mass Index (BMI)
Délai: Baseline
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Calculated using height and body weight via a Tanita BC-420SMA Bioelectrical Impedance Analyzer. |
Baseline
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Aybüke Fanuscu, Pt, PhD, Bingol University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AF-202603
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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