An observational study in Hypogonadism, Male, Body Composition and Physical Activity, sponsored by Hacettepe University. Recruiting at 2 sites in Turkey (Türkiye). Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Hacettepe University · Observational
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.
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.
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's planned enrollment of 45 is below the median of 100 across 17 observational studies indexed under Eunuchism.
Browse Eunuchism studies →Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Physical Activity Level
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.
Time frame: Baseline
Exercise Self-Efficacy Score
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.
Time frame: Baseline
Body Weight
Measured using a Tanita BC-420SMA Bioelectrical Impedance Analyzer. This outcome reports body weight in kilograms.
Time frame: Baseline
Serum Total Testosterone Level
Recorded from recent morning routine clinical laboratory records. Measured in nanograms per deciliter (ng/dL).
Time frame: Baseline
Depressive Symptoms (Covariate)
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.
Time frame: Baseline
Body Mass Index (BMI)
Calculated using height and body weight via a Tanita BC-420SMA Bioelectrical Impedance Analyzer.
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Sep 2027, 11 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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