Muscle Weakness Clinical Trial
— PROGRESSOfficial title:
Effect of PROGRESSive Resistance Training, Protein Supplements and Testosterone in Older Frail Men With Testosterone Deficiency (PROGRESS Trial)
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.
Status | Recruiting |
Enrollment | 196 |
Est. completion date | January 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 70 Years and older |
Eligibility | 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)). 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Karsten Overgaard | Hellerup | Danmark |
Denmark | Medical Dept. O, Geriatric Section | Herlev |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gentofte, Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stand-up-and Sit-test | 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). | up to 5 months (at study completion) | |
Secondary | Frequency and severity of falls via questionaire | included in the monitoring of adverse events. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Balance ability, | Tandem Test containing three starting positions: 1) Standing with feet together, standing in the semi-tandem position and standing in the tandem stand. coupled with decrease risk of fall. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Avlund mobility scale | Questions about experiencing fatigue and support needs of ordinary everyday activities. Avlund mobility scale is correlated with the isometric muscle strength, simple function tests , increased risk of hospitalization and mortality | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Leg extensor Power Rig test | An instrument for measuring muscle strength in the lower extremities. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Isometric muscle strength | Measurement of isometric muscle strength m. quadriceps in a seated leg press. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Armflexion Test: | Measures of overall strength in the upper extremities. The number of times the participant can inflect the elbow with dumbbell is measured in 30 sec. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | 2-minute knee lift test: | Measures aerobic capacity in the elderly. Number of high knee lifts in 2 minutes. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | 2,45minute up-and-go test: | Target for basic mobility in the elderly. Time it takes to rise from a chair, walk around a cone 2,45m away, go back and sit down again. Moderate to good correlation between the corresponding 3m test and Berg Balance Scale (r = 0.81), walking speed (r = 0.61) and Barthel index (r = 0.78) and a good test-retest- reliability (ICC = 0.98). | At baseline, 1 month, 5 months (at study completion) | |
Secondary | DXA scan | Lean body mass. Measurement of fat and fat-free mass and total bone mass (BMC). Executed only at baseline and at study end. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Bone Mineral Density | Of the spine, distal forearm bilaterally, total hip bilaterally and in the skeleton as a whole (total body). In case of osteoporosis treatment will be initiated following the department's usual guidelines, which can blur the results for bone density. | At baseline, 1 month, 5 months (at study completion | |
Secondary | Major Depression Inventory (MDI): | Questionnaire on depression and mental well-being. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Montreal Cognitive Assessment (MoCA): | A cognitive screening test that provides an estimate of the intellectual functioning; This test is also sensitive to mild cognitive problems and dementia. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Quality of Life EQ-5D: | Questionnaire on the experienced quality of life. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Modified PISQ-12: | An assessment of sexual performance (potency) and sexual desire. There are previously found improved sexual function, mood, muscle strength and body composiAn evaluation questionnaire of sexual function | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Aastrands Test: | Sub-maximal fitness test performed on a treadmill. Includes monitoring heart rate | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Measurements of the Heart Rate Variability (HRV) | Studies have indicated that hypogonodal men can improve the Heart Rate Variability by testosterone treatment | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Dual-energy X-ray absorptiometry | Measurement of the body composition bioimpedance. | At baseline, 1 month, 5 months (at study completion) | |
Secondary | Safety parameters - blood pressure | Blood pressure. Blood samples: Serum testosterone, hemoglobin, hematocrit, lipid profile, Potassium, Natrium, creatinine, CRP, AST, bilirubin, alkaline phosphatase, TSH, p-ionized calcium, PTH, Ca ++, and 25-OH vitamin D. | Measured every four weeks through the study (for 5 months) | |
Secondary | Side effects | Measuring a lot of posssible side effects to training and testosterone | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - testosterone level | Measuring levels of testosterone and safely parameter | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - hemoglobin level | Measuring levels hemoglobin | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - hematocrit level | Measuring levels of hematocrit | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - lipid profile | Measuring levels cholesterol | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - Potassium | Measuring levels of potassium | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - Natrium | Measuring levels of natrium | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - creatinine | Measuring levels of creatinine | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - CRP | Measuring levels of CRP | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - Aspartate aminotransferase (AST) | Measuring levels of aspartate aminotransferase (AST) | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - bilirubin | Measuring levels of bilirubin | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - alkaline phosphatase | Measuring levels of alkaline phosphatase | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - Thyreoid Stimulating Hormone (TSH) | Measuring levels of TSH | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - p-ionized calcium | Measuring levels of p-ionized calcium | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - PTH | Measuring levels of PTH | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - Ca ++ | Measuring levels of Ca2+ | Measured every four weeks through the study (for 5 months) | |
Secondary | Safety parameters - blood sample - 25-OH vitamin D. | Measuring levels of vitamin D | Measured every four weeks through the study (for 5 months) |
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