Effect of PROGRESSive Resistance Training, Protein Supplements and Testosterone in Older Frail Men With Testosterone Deficiency (PROGRESS Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Stand-up-and Sit-test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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 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.
研究组 & 干预措施
Testosterone
A testosterone group given 20 weeks on testosterone injections without training
干预措施: testosterone (Drug)
Training
A Training Group, which is 20 weeks with placebo injections and 16 weeks of progressive resistance training supplemented with vitamin D and protein supplements
干预措施: Progressive muscle training (Other)
Testosterone and training
A combination group that is 20 weeks with testosterone injections and 16 weeks of progressive resistance training supplemented with vitamin D and protein supplements
干预措施: testosterone (Drug)
Testosterone and training
A combination group that is 20 weeks with testosterone injections and 16 weeks of progressive resistance training supplemented with vitamin D and protein supplements
干预措施: Progressive muscle training (Other)
结局指标
主要结局
Stand-up-and Sit-test
时间窗: up to 5 months (at study completion)
It is a measure of overall strength in the lower extremities. Result of the test is defined as the number of times the participant can stand up and sit from a chair in 30 seconds. There is a good correlation (r = 0.78) with a leg press and an acceptable test-retest reliability (ICC = 0.86).
次要结局
- Balance ability,(At baseline, 1 month, 5 months (at study completion))
- Frequency and severity of falls via questionaire(At baseline, 1 month, 5 months (at study completion))
- Avlund mobility scale(At baseline, 1 month, 5 months (at study completion))
- Leg extensor Power Rig test(At baseline, 1 month, 5 months (at study completion))
- Isometric muscle strength(At baseline, 1 month, 5 months (at study completion))
- Armflexion Test:(At baseline, 1 month, 5 months (at study completion))
- 2-minute knee lift test:(At baseline, 1 month, 5 months (at study completion))
- 2,45minute up-and-go test:(At baseline, 1 month, 5 months (at study completion))
- DXA scan(At baseline, 1 month, 5 months (at study completion))
- Bone Mineral Density(At baseline, 1 month, 5 months (at study completion)
- Major Depression Inventory (MDI):(At baseline, 1 month, 5 months (at study completion))
- Montreal Cognitive Assessment (MoCA):(At baseline, 1 month, 5 months (at study completion))
- Quality of Life EQ-5D:(At baseline, 1 month, 5 months (at study completion))
- Modified PISQ-12:(At baseline, 1 month, 5 months (at study completion))
- Aastrands Test:(At baseline, 1 month, 5 months (at study completion))
- Measurements of the Heart Rate Variability (HRV)(At baseline, 1 month, 5 months (at study completion))
- Dual-energy X-ray absorptiometry(At baseline, 1 month, 5 months (at study completion))
- Safety parameters - blood pressure(Measured every four weeks through the study (for 5 months))
- Side effects(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - testosterone level(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - hemoglobin level(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - hematocrit level(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - lipid profile(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - Potassium(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - Natrium(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - creatinine(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - CRP(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - Aspartate aminotransferase (AST)(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - bilirubin(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - alkaline phosphatase(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - Thyreoid Stimulating Hormone (TSH)(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - p-ionized calcium(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - PTH(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - Ca ++(Measured every four weeks through the study (for 5 months))
- Safety parameters - blood sample - 25-OH vitamin D.(Measured every four weeks through the study (for 5 months))
研究者
Rune Skovgaard Rasmussen
Neuropychologist, Ph.D., associate professor
University Hospital, Gentofte, Copenhagen