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Trial record 66 of 97 for:    calcium cation

Effect of PROGRESSive Training and Teststerone in Older Frail Men (PROGRESS)

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ClinicalTrials.gov Identifier: NCT02873559
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Rune Skovgaard Rasmussen, University Hospital, Gentofte, Copenhagen

Brief 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.

Condition or disease Intervention/treatment Phase
Muscle Weakness Drug: testosterone Other: Progressive muscle training Phase 2 Phase 3

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of PROGRESSive Resistance Training, Protein Supplements and Testosterone in Older Frail Men With Testosterone Deficiency (PROGRESS Trial)
Study Start Date : November 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Controls
A control group, which is 20 weeks with placebo injections without training.
Experimental: Testosterone
A testosterone group given 20 weeks on testosterone injections without training
Drug: testosterone
Testosterone supplemented in 5 months

Experimental: 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
Other: Progressive muscle training
Progressive muscle training during 4 months
Other Name: Training

Experimental: 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
Drug: testosterone
Testosterone supplemented in 5 months

Other: Progressive muscle training
Progressive muscle training during 4 months
Other Name: Training




Primary Outcome Measures :
  1. Stand-up-and Sit-test [ Time Frame: 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).


Secondary Outcome Measures :
  1. Frequency and severity of falls via questionaire [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    included in the monitoring of adverse events.

  2. Balance ability, [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    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.

  3. Avlund mobility scale [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    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

  4. Leg extensor Power Rig test [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    An instrument for measuring muscle strength in the lower extremities.

  5. Isometric muscle strength [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    Measurement of isometric muscle strength m. quadriceps in a seated leg press.

  6. Armflexion Test: [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    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.

  7. 2-minute knee lift test: [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    Measures aerobic capacity in the elderly. Number of high knee lifts in 2 minutes.

  8. 2,45minute up-and-go test: [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    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).

  9. DXA scan [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    Lean body mass. Measurement of fat and fat-free mass and total bone mass (BMC). Executed only at baseline and at study end.

  10. Bone Mineral Density [ Time Frame: At baseline, 1 month, 5 months (at study completion ]
    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.

  11. Major Depression Inventory (MDI): [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    Questionnaire on depression and mental well-being.

  12. Montreal Cognitive Assessment (MoCA): [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    A cognitive screening test that provides an estimate of the intellectual functioning; This test is also sensitive to mild cognitive problems and dementia.

  13. Quality of Life EQ-5D: [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    Questionnaire on the experienced quality of life.

  14. Modified PISQ-12: [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    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

  15. Aastrands Test: [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    Sub-maximal fitness test performed on a treadmill. Includes monitoring heart rate

  16. Measurements of the Heart Rate Variability (HRV) [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    Studies have indicated that hypogonodal men can improve the Heart Rate Variability by testosterone treatment

  17. Dual-energy X-ray absorptiometry [ Time Frame: At baseline, 1 month, 5 months (at study completion) ]
    Measurement of the body composition bioimpedance.

  18. Safety parameters - blood pressure [ Time Frame: Measured every four weeks through the study (for 5 months) ]
    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.

  19. Side effects [ Time Frame: Measured every four weeks through the study (for 5 months) ]
    Measuring a lot of posssible side effects to training and testosterone

  20. Safety parameters - blood sample - testosterone level [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  21. Safety parameters - blood sample - hemoglobin level [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  22. Safety parameters - blood sample - hematocrit level [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  23. Safety parameters - blood sample - lipid profile [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  24. Safety parameters - blood sample - Potassium [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  25. Safety parameters - blood sample - Natrium [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  26. Safety parameters - blood sample - creatinine [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  27. Safety parameters - blood sample - CRP [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  28. Safety parameters - blood sample - Aspartate aminotransferase (AST) [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  29. Safety parameters - blood sample - bilirubin [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  30. Safety parameters - blood sample - alkaline phosphatase [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  31. Safety parameters - blood sample - Thyreoid Stimulating Hormone (TSH) [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  32. Safety parameters - blood sample - p-ionized calcium [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  33. Safety parameters - blood sample - PTH [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  34. Safety parameters - blood sample - Ca ++ [ Time Frame: Measured every four weeks through the study (for 5 months) ]
  35. Safety parameters - blood sample - 25-OH vitamin D. [ Time Frame: Measured every four weeks through the study (for 5 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873559


Contacts
Contact: Karsten Overgaard, M.D. +45 2617 2611 karstenovergaard20@hotmail.com
Contact: Rune S. Rasmussen, MA, PhD +45 2875 7500 rsr@sund.ku.dk

Locations
Denmark
Karsten Overgaard Recruiting
Hellerup, Danmark, Denmark, DK-2900
Contact: Karsten Overgaard, neurologist    +45 2617 2611    karstenovergaard20@hotmail.com   
Contact: Rune Rasmussen, PhD neuropsy    +45 2875 7500    rsr@sund.ku.dk   
Principal Investigator: Mette Midttun, M.D. DMSci         
Medical Dept. O, Geriatric Section Recruiting
Herlev, Denmark, 2730
Contact: Mette Midttun, MD, DMSc    +45 38689188    mette.midttun@regionh.dk   
Principal Investigator: Mette Midttun, MD, DMSc         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Study Director: Karsten Overgaard, M.D. Herlev Hospital, Neurological Department N108

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rune Skovgaard Rasmussen, Neuropychologist, Ph.D., associate professor, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT02873559     History of Changes
Other Study ID Numbers: Ethical protocol H-16020521
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rune Skovgaard Rasmussen, University Hospital, Gentofte, Copenhagen:
older
frail
men
progressive muscle training
muscle training
exercise
testosterone

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents