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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Emine Şener Aydın, MD
- Telefonnummer: +904222118019
- E-mail: dreminesener@windowslive.com
Studiesteder
-
-
-
Bingoel, Tyrkiet (Türkiye)
- Rekruttering
- Bingol University Faculty of Physical Therapy and Rehabilitation
-
Kontakt:
- Aybüke Fanuscu, Pt, PhD
- Telefonnummer: 5548 +904262160012
- E-mail: afanuscu@bingol.edu.tr
-
Malatya, Tyrkiet (Türkiye)
- Rekruttering
- Malatya Training and Research Hospital
-
Kontakt:
- Emine Şener Aydın, MD
- E-mail: dreminesener@windowslive.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: OTHER
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical Activity Level
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise Self-Efficacy Score
Tidsramme: 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
Tidsramme: Baseline
|
Measured using a Tanita BC-420SMA Bioelectrical Impedance Analyzer. This outcome reports body weight in kilograms. |
Baseline
|
|
Serum Total Testosterone Level
Tidsramme: Baseline
|
Recorded from recent morning routine clinical laboratory records. Measured in nanograms per deciliter (ng/dL). |
Baseline
|
|
Depressive Symptoms (Covariate)
Tidsramme: 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)
Tidsramme: Baseline
|
Calculated using height and body weight via a Tanita BC-420SMA Bioelectrical Impedance Analyzer. |
Baseline
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Aybüke Fanuscu, Pt, PhD, Bingol University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AF-202603
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .