Effect of PROGRESSive Training and Teststerone in Older Frail Men (NCT02873559) | Clinical Trial Compass
CompletedPhase 2/3
Effect of PROGRESSive Training and Teststerone in Older Frail Men
Denmark192 participantsStarted 2016-11-01
Plain-language summary
In this scientific clinical investigation we will test whether testosterone and progressive resistance training can improve muscle strength and reduce the risk of falls in older men. In addition, we will examine whether this treatment improves quality of life, functional capacity, including sexual function and counteracts depression. Such a project have not been performed earlier.
Who can participate
Age range70 Years
SexMALE
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Inclusion Criteria:
Living in their own home or in sheltered accommodation. Independent gait possible. with tool. Capable of stand-up and sit in a chair at least 8 times in 30 sec. There must be at least 3 symptoms or objective findings of low testosterone . Serum testosterone \<10nmol /L as the average of two independent measurements
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Exclusion Criteria:
Known or previous prostate cancer. Abnormally elevated serum PSA (PSA = prostate specific antigen) corresponding to PSA\> 5 ng / ml or PSA\> 0.15 ng / ml / cc (relative to the prostatic volume in cubic centimeters (cc)). Hæmatomacrose. Heart disease in the form of: peri-, myo-, or endocarditis, angina, severe heart failure (NYHA class III and IV), severe hypertension (systolic blood pressure\> 180 or diastolic BT\> 105 mmHg after antihypertensive therapy). Dyspnoea at rest. Liver (AST\> 2 x ULN) or renal impairment (serum creatinine\> 200 micromoles / L). Severe and insufficiently treated epilepsy or migraine. Insulin treatment. Previous or current bifosfonat-, fluoride, HRT, SERM-, strontium, teraparatid- or more than 3 weeks of prednisolone. Joint disease with acute inflammation. Active cancer disease in chemo- or radiotherapy. Bone metabolic disease apart from age-related osteoporosis. Autoimmune diseases, chronic systemic diseases (cirrhosis, AIDS, chronic renal failure). Primary testosterone deficiency in the form of testicular dysgenesis, Klinefelter syndrome (47, XXY), 46, XX males, LH-resistance, the Y chromoso…