Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism (ExLOH)

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Life Style, Healthy; Physical Inactivity; Autonomic Imbalance; Hypogonadism, Male; Metabolic Syndrome

Treatments: Behavioral: Structured and personalized program of physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06094036

45C202

Details and patient eligibility

About

Aim of this project is to delineate sustainable physical exercise programs and to assess the effects of such programs mainly on endocrine-metabolic and neurovegetative outcomes in a cohort of men with metabolic syndrome-related late-onset central hypogonadism.

Participants will undergo a personalised exercise program. After 6 months they will be subdivided into two groups, according to the weekly physical activity volume actually performed (above or below 600 MET·minutes/week). Changes in endocrine-metabolic and neurovegetative outcomes will be compared between the two groups.

Enrollment: 72 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of late-onset central hypogonadism: total T levels < 8 nmol/L (or < 12 nmol/L in the presence of calculated free T < 225 pmol/L) combined with sexual symptoms (erectile dysfunction, low libido and loss of waking erections) [12];
• diagnosis of metabolic syndrome, defined as association of waist circumference (WC) > 94 cm and at least two among the following criteria: triglycerides ≥ 150 mg/dl, HDL-C < 40 mg/dl, glucose > 100 mg/dl, blood pressure (BP) ≥ 130/85 mmHg [33];
• ability to give informed consent, in accordance with good clinical practice rules and applicable national laws.

Exclusion criteria

• History of hypothalamus-pituitary organic disorders and/or testicular diseases;
• impossibility to assess cardiac autonomic regulation due to arrhythmias and/or current treatment for heart rate (HR) control (e.g., beta-blockers, antiarrhythmics);
• impossibility to undergo clinical assessment;
• impossibility or contraindications to perform exercise program (for instance, psychiatric disorders, severe musculoskeletal diseases, arrhythmias);
• inability to give informed consent or unwillingness to be enrolled in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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72 participants in 2 patient groups

weekly physical activity volume performed above 600 MET·minutes/week

Other group

Description:

Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.

Treatment:

Behavioral: Structured and personalized program of physical exercise

weekly physical activity volume performed below 600 MET·minutes/week

Other group

Description:

Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.

Treatment:

Behavioral: Structured and personalized program of physical exercise