Effect of PROGRESSive Training and Teststerone in Older Frail Men

  • STATUS
    Recruiting
  • End date
    Jan 4, 2022
  • participants needed
    196
  • sponsor
    University Hospital, Gentofte, Copenhagen
Updated on 4 April 2021
depression
testosterone
resistance training

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.

Description

Project background: In Denmark more than 1,000 people each year die of a fall, which is more than five times as many dying in traffic accidents. Fall accidents are also the leading cause of traumatic brain injury and is a relatively unnoticed problem, although this type of accidents causes more hospital bed days than all other accidents combined.

Annually, almost half of the 375,000 elderly Danes over 75 years of age and relatively three times as many of the approximately 40,000 elderly people in nursing homes fall every year, causing over 40,000 hospital contacts annually. Ten percent of all elderly people hospitalized each year because of a fall, mostly with fractures, for which the risk increases fivefold after a fall. In Denmark there are now now around 1 million people over 65 years of age. Over the next 25 years we will experience a 50% growth to 1.5 million people over 65 years of age.

Injury, disability and death caused by falls is therefore a widespread and growing human and societal problem. Many will never recover completely and will therefore need help to cope with everyday life. After the first fall risk increase for repeated falls. Especially for older people living in their own homes permanent or temporary disabilities results in a severe deterioration of the quality of life. Treatment of falls is also a significant financial burden on health and social care.

The main reason for the decline is muscle weakness. Muscle weakness leads to greatly increased risk of falling, decreased quality of life and functional capacity. Musclemass and -power decrease about 40 percent from age 20 to 80 years old.

Recent studies have shown that even 90-year-old persons can double their muscle strength by intensive training just three times per week. The level of the male sex hormone testosterone decreases with age and leads to impaired muscle mass. Twenty percent of men over 60 and 50 percent over 80 years, a low level of testosterone in total equivalent to more than 100,000 Danes. From the human and socio-economic perspective, it is important to find treatments that can enhance function in the elderly.

Details
Condition Muscle Weakness, Hemiparesis, paresis, muscle paresis, decrease in muscle strength, decreased muscle strength
Treatment testosterone, Progressive muscle training
Clinical Study IdentifierNCT02873559
SponsorUniversity Hospital, Gentofte, Copenhagen
Last Modified on4 April 2021

Eligibility

Yes No Not Sure

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
\-

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))
Hmatomacrose. 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
chromosome deletions, other sex chromosome abnormalities ,. Significant abuse
mental illness, dementia, physical disability with inability to implement
intervention or tests or to give informed consent. Contraindications to
testosterone undecanoate is included in the exclusion criteria, such as
presence of liver tumors, breast and prostate cancer, as subjects will be
examined before the trial starts
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