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Exercise Self-Efficacy, Body Composition, and Physical Activity in Men With Hypogonadism

2026. november 6. frissítette: Aybüke Fanuscu, Hacettepe University

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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Név: Emine Şener Aydın, MD
Telefonszám: +904222118019
E-mail: dreminesener@windowslive.com

Tanulmányi helyek

Törökország (Türkiye)
- - Bingoel, Törökország (Türkiye)
    - Toborzás
    - Bingol University Faculty of Physical Therapy and Rehabilitation
    - Kapcsolatba lépni:
      
      Aybüke Fanuscu, Pt, PhD
      
      Telefonszám: 5548 +904262160012
      
      E-mail: afanuscu@bingol.edu.tr
  - Malatya, Törökország (Türkiye)
    - Toborzás
    - Malatya Training and Research Hospital
    - Kapcsolatba lépni:
      
      Emine Şener Aydın, MD
      
      E-mail: dreminesener@windowslive.com

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Férfi

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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).

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Megfigyelési modellek: OTHER
Időperspektívák: PROSPECTIVE

Csoportok/kohorszok száma

Kohorszok és beavatkozások

Csoport / Kohorsz
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).

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Physical Activity Level Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Exercise Self-Efficacy Score Időkeret: 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 Időkeret: Baseline	Measured using a Tanita BC-420SMA Bioelectrical Impedance Analyzer. This outcome reports body weight in kilograms.	Baseline
Serum Total Testosterone Level Időkeret: Baseline	Recorded from recent morning routine clinical laboratory records. Measured in nanograms per deciliter (ng/dL).	Baseline
Depressive Symptoms (Covariate) Időkeret: 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) Időkeret: Baseline	Calculated using height and body weight via a Tanita BC-420SMA Bioelectrical Impedance Analyzer.	Baseline

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Hacettepe University

Nyomozók

Kutatásvezető: Aybüke Fanuscu, Pt, PhD, Bingol University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. október 20.

Elsődleges befejezés (Becsült)

2027. szeptember 30.

A tanulmány befejezése (Becsült)

2027. október 15.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. augusztus 4.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 6.

Első közzététel (Tényleges)

2026. november 9.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)