The purpose of this study is to increase the functional level of the elderly to thereby reduce fall risk, improve motor skills, and increase psychological well-being, as well as to assess whether the restoration of a normal testosterone level contributes to a faster recovery. The effect of testosterone is investigated as measured by physical and mental functional capacity, including cognition, in hypogonadal elderly men with a significant loss of function. The study is aimed at participants who are too weak to participate in the progressive strength training.
Men aged 70 or over.
Living at home in their own home or in sheltered housing.
Independent walking function, possibly with a walking aid.
Able to perform the chair-stand test a maximum of 8 times in 30 seconds or Timed Up and Go (TUG) of at least 30 seconds.
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 prostate size in cubic centimeters (cc)).
Hemochromatosis.
Heart diseases in the form of: Peri-, myo-, or endocarditis, angina pectoris, severe heart failure (NYHA class III and IV), severe hypertension (systolic BP > 180 or diastolic BP > 105 mmHg after possible antihypertensive treatment). - Resting dyspnea.
Parallel
Nebido (Testosterone Undecanoate)
DrugTestosterone supplementation is given intramuscularly with 1000 mg testosterone undecanoate, which has an effect for approx. 12 weeks, but which can be repeated more frequently between the 1st and 2nd administration. The injection is thus repeated in week 6. 3 injections per trial subject are expected, i.e., in weeks 1, 6, and 16. If the participants are motivated to continue so that long-term effects can be measured, the participants will be asked in week 12 whether they wish to continue to week 52. Upon acceptance of continuation to week 52, testosterone and placebo injections are offered according to original groups in weeks 26, 36, and 46, after which testing of primary and secondary endpoints is not only performed in week 20 but also in week 52.
Chair-stand test
A measure of general strength in extremities. Number of times the participant can stand up and sit down from a chair in 30 seconds. A good correlation (r=0.78) has been found with leg press and acceptable test-retest reliability (ICC=0.86). It has recently been scientifically documented that the ability among elderly persons to perform this simple test correlates with the risk of serious fall accidents
Measurement of fall frequency and severity
Registered via a questionnaire for each trial subject and is also included in the monitoring of adverse events.
Balance ability
Tested via the Tandem test, which contains three starting positions: 1) Standing with feet together, standing in semi-tandem stance, and standing in tandem stance.
Avlund's mobility scale
Questions about experiencing fatigue and need for support in common activities of daily living. Avlund's mobility scale is correlated with isometric muscle strength, simple functional tests, increased risk of hospitalizations, and mortality. Good inter- and intra-reliability (kappa 0.72-1.00) has been shown. Scores range from 0 to 6, and higher scores indicate worse outcome.
Geriatric Depression Scale (GDS)
Questionnaire about depression and psychological well-being. Scores range from 0 til 15. Score below 5 are normal, while scores of 5 or higher indicate varying degrees of depression, scoring 13-15 indicates severe depression.
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Rune Skovgaard Rasmussen
Lead sponsor
University Hospital, Gentofte, Copenhagen
Sponsor institution
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