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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Emine Şener Aydın, MD
- Número de teléfono: +904222118019
- Correo electrónico: dreminesener@windowslive.com
Ubicaciones de estudio
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Bingoel, Turquía (Türkiye)
- Reclutamiento
- Bingol University Faculty of Physical Therapy and Rehabilitation
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Contacto:
- Aybüke Fanuscu, Pt, PhD
- Número de teléfono: 5548 +904262160012
- Correo electrónico: afanuscu@bingol.edu.tr
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Malatya, Turquía (Türkiye)
- Reclutamiento
- Malatya Training and Research Hospital
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Contacto:
- Emine Şener Aydın, MD
- Correo electrónico: dreminesener@windowslive.com
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / 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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Physical Activity Level
Periodo de tiempo: 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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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Exercise Self-Efficacy Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline
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Calculated using height and body weight via a Tanita BC-420SMA Bioelectrical Impedance Analyzer. |
Baseline
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Aybüke Fanuscu, Pt, PhD, Bingol University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- AF-202603
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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