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.
Please see the uploaded study protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Testosterone 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.
Holbæk Hospital
Holbæk, Denmark
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
Time frame: At weeks 0, 4 and 20.
Measurement of fall frequency and severity
Registered via a questionnaire for each trial subject and is also included in the monitoring of adverse events.
Time frame: At weeks 0, 4 and 20.
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.
Time frame: At weeks 0, 4 and 20.
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.
Time frame: At weeks 0, 4 and 20.
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.
Time frame: At weeks 0, 4 and 20.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a cognitive screening instrument which provides an estimate of the level of intellectual functioning. Scores are from 0 to 30, where a score of 26 or higher is considered normal. Montreal Cognitive Assessment is moreover sensitive to mild cognitive problems as well as dementia. Studies have shown that Montreal Cognitive Assessment is more sensitive than Mini Mental State Examination to detecting mild cognitive changes and is as effective in identifying the incidence of Alzheimer's disease.
Time frame: At weeks 0, 4 and 20.
Mini Mental State Examination (MMSE)
Cognitive screening test that provides an estimate of the intellectual functional level. This test is included as it is performed as standard at the Geriatric Outpatient Clinic. Combined, MMSE and MoCA provide a broader assessment of cognitive functional level. Scores range from 0 to 30, higher scores indicate better cognitive status. Scores from 26 to 30 are considered normal.
Time frame: At weeks 0, 4 and 20.
Quality of life EQ-5D
Questionnaire about perceived quality of life. Scores range from 0 to 1 (first scale) and from 0 to 100 (second scale). Higher scores indicate better quality of life.
Time frame: At weeks 0, 4 and 20.
Clinical Frailty Scale (CFS)
General assessment of health and functional level in the elderly. Scoring ranges from 1 to 9, and higher scores indicate more frailty.
Time frame: At weeks 0, 4 and 20.
Falls Efficacy Scale - International (FES-I, Fear of falling). Scores range from 16 to 64, and higher scores indicate increased anxiety of having a severe fall accident.
Assessment of fall risk in the elderly.
Time frame: At weeks 0, 4 and 20.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.