Muscle WeaknessPhase 2/3PROGRESSNCT02873559
Effect of PROGRESSive Training and Teststerone in Older Frail Men
A Phase 2/3 study testing testosterone and Progressive muscle training in people with Muscle Weakness, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- testosterone and Progressive muscle training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Nov 2016to Mar 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
- -
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Karsten Overgaard
Hellerup, Danmark, DK-2900
Medical Dept. O, Geriatric Section
Herlev, 2730
About this study
Official 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.
Read the 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.
- Conditions
- Muscle Weakness
- Being tested
- testosterone, Progressive muscle training
- Keywords
- older, frail, men, progressive muscle training, muscle training, exercise, testosterone
- Medical subject headings
- Muscle Weakness, Multiple Endocrine Neoplasia Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosteroneDrug
Testosterone supplemented in 5 months
Progressive muscle trainingOther
Also called Training
Progressive muscle training during 4 months
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | A control group, which is 20 weeks with placebo injections without training. |
| Testosterone | Experimental | A testosterone group given 20 weeks on testosterone injections without training Receives: Drug: testosterone |
| Training | Experimental | A Training Group, which is 20 weeks with placebo injections and 16 weeks of progressive resistance training supplemented with vitamin D and protein supplements Receives: Other: Progressive muscle training |
| Testosterone and training | Experimental | A combination group that is 20 weeks with testosterone injections and 16 weeks of progressive resistance training supplemented with vitamin D and protein supplements Receives: Drug: testosterone; Other: Progressive muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 5 months (at study completion)
Secondary outcomes (35)
Frequency and severity of falls via questionaire
included in the monitoring of adverse events.
Measured: At baseline, 1 month, 5 months (at study completion)
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.
Measured: At baseline, 1 month, 5 months (at study completion)
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
Measured: At baseline, 1 month, 5 months (at study completion)
Leg extensor Power Rig test
An instrument for measuring muscle strength in the lower extremities.
Measured: At baseline, 1 month, 5 months (at study completion)
Isometric muscle strength
Measurement of isometric muscle strength m. quadriceps in a seated leg press.
Measured: At baseline, 1 month, 5 months (at study completion)
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.
Measured: At baseline, 1 month, 5 months (at study completion)
2-minute knee lift test:
Measures aerobic capacity in the elderly. Number of high knee lifts in 2 minutes.
Measured: At baseline, 1 month, 5 months (at study completion)
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).
Measured: At baseline, 1 month, 5 months (at study completion)
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.
Measured: At baseline, 1 month, 5 months (at study completion)
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.
Measured: At baseline, 1 month, 5 months (at study completion
Major Depression Inventory (MDI):
Questionnaire on depression and mental well-being.
Measured: At baseline, 1 month, 5 months (at study completion)
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.
Measured: At baseline, 1 month, 5 months (at study completion)
Quality of Life EQ-5D:
Questionnaire on the experienced quality of life.
Measured: At baseline, 1 month, 5 months (at study completion)
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
Measured: At baseline, 1 month, 5 months (at study completion)
Aastrands Test:
Sub-maximal fitness test performed on a treadmill. Includes monitoring heart rate
Measured: At baseline, 1 month, 5 months (at study completion)
Measurements of the Heart Rate Variability (HRV)
Studies have indicated that hypogonodal men can improve the Heart Rate Variability by testosterone treatment
Measured: At baseline, 1 month, 5 months (at study completion)
Dual-energy X-ray absorptiometry
Measurement of the body composition bioimpedance.
Measured: At baseline, 1 month, 5 months (at study completion)
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: Measured every four weeks through the study (for 5 months)
Side effects
Measuring a lot of posssible side effects to training and testosterone
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - testosterone level
Measuring levels of testosterone and safely parameter
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - hemoglobin level
Measuring levels hemoglobin
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - hematocrit level
Measuring levels of hematocrit
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - lipid profile
Measuring levels cholesterol
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - Potassium
Measuring levels of potassium
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - Natrium
Measuring levels of natrium
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - creatinine
Measuring levels of creatinine
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - CRP
Measuring levels of CRP
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - Aspartate aminotransferase (AST)
Measuring levels of aspartate aminotransferase (AST)
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - bilirubin
Measuring levels of bilirubin
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - alkaline phosphatase
Measuring levels of alkaline phosphatase
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - Thyreoid Stimulating Hormone (TSH)
Measuring levels of TSH
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - p-ionized calcium
Measuring levels of p-ionized calcium
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - PTH
Measuring levels of PTH
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - Ca ++
Measuring levels of Ca2+
Measured: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - 25-OH vitamin D.
Measuring levels of vitamin D
Measured: Measured every four weeks through the study (for 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start1 Nov 2016
- Primary completion31 Mar 2022
- Study completionMar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rune Skovgaard Rasmussen, University Hospital, Gentofte, Copenhagen
- Investigators
- Karsten Overgaard, M.D., Study director, Herlev Hospital, Neurological Department N108
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873559
- Sponsor's protocol ID
- Ethical protocol H-16020521
- Acronym
- PROGRESS
- Status last verified
- May 2024
- First submitted
- 12 Aug 2016
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rasmussen RS, Midttun M, Zerahn B, Pedersen M, Rashid A, Ostergren PB, Paulin TK, Podenphanth TW, Karlsson LK, Rosendahl E, Ragle AM, Vinther A, Overgaard K. Testosterone and resistance training improved physical performance and reduced fatigue in frail older men: 1 year follow-up of a randomized clinical trial. Aging Male. 2024 Dec;27(1):2403519. doi: 10.1080/13685538.2024.2403519. Epub 2024 Sep 17.
PubMed 39289825Rasmussen R, Midttun M, Kolenda T, Ragle AM, Sorensen TW, Vinther A, Zerahn B, Pedersen M, Overgaard K. Therapist-Assisted Progressive Resistance Training, Protein Supplements, and Testosterone Injections in Frail Older Men with Testosterone Deficiency: Protocol for a Randomized Placebo-Controlled Trial. JMIR Res Protoc. 2018 Mar 2;7(3):e71. doi: 10.2196/resprot.8854.
PubMed 29500160
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PROGRESSive Resistance Training, Protein Supplements and Testosterone in Older Frail Men With Testosterone Deficiency (PROGRESS Trial)
- ClinicalTrials.gov ID
- NCT02873559
- Acronym / sponsor ID
- PROGRESS / Ethical protocol H-16020521
- Conditions
- Muscle Weakness
- Keywords
- older, frail, men, progressive muscle training, muscle training, exercise, testosterone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –A control group, which is 20 weeks with placebo injections without training. |
| Testosterone | Experimental | Drug: testosteroneA testosterone group given 20 weeks on testosterone injections without training |
| Training | Experimental | Other: Progressive muscle trainingA Training Group, which is 20 weeks with placebo injections and 16 weeks of progressive resistance training supplemented with vitamin D and protein supplements |
| Testosterone and training | Experimental | Drug: testosterone, Other: Progressive muscle trainingA combination group that is 20 weeks with testosterone injections and 16 weeks of progressive resistance training supplemented with vitamin D and protein supplements |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
- -
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testosteroneTestosterone supplemented in 5 months | Drug | Testosterone, Testosterone and training |
| Progressive muscle trainingAlso: TrainingProgressive muscle training during 4 months | Other | Testosterone and training, Training |
Primary outcome
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).
35 secondary outcomes
Frequency and severity of falls via questionaire
Time frame: At baseline, 1 month, 5 months (at study completion)
Balance ability,
Time frame: At baseline, 1 month, 5 months (at study completion)
Avlund mobility scale
Time frame: At baseline, 1 month, 5 months (at study completion)
Leg extensor Power Rig test
Time frame: At baseline, 1 month, 5 months (at study completion)
Isometric muscle strength
Time frame: At baseline, 1 month, 5 months (at study completion)
Armflexion Test:
Time frame: At baseline, 1 month, 5 months (at study completion)
2-minute knee lift test:
Time frame: At baseline, 1 month, 5 months (at study completion)
2,45minute up-and-go test:
Time frame: At baseline, 1 month, 5 months (at study completion)
DXA scan
Time frame: At baseline, 1 month, 5 months (at study completion)
Bone Mineral Density
Time frame: At baseline, 1 month, 5 months (at study completion
Major Depression Inventory (MDI):
Time frame: At baseline, 1 month, 5 months (at study completion)
Montreal Cognitive Assessment (MoCA):
Time frame: At baseline, 1 month, 5 months (at study completion)
Quality of Life EQ-5D:
Time frame: At baseline, 1 month, 5 months (at study completion)
Modified PISQ-12:
Time frame: At baseline, 1 month, 5 months (at study completion)
Aastrands Test:
Time frame: At baseline, 1 month, 5 months (at study completion)
Measurements of the Heart Rate Variability (HRV)
Time frame: At baseline, 1 month, 5 months (at study completion)
Dual-energy X-ray absorptiometry
Time frame: At baseline, 1 month, 5 months (at study completion)
Safety parameters - blood pressure
Time frame: Measured every four weeks through the study (for 5 months)
Side effects
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - testosterone level
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - hemoglobin level
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - hematocrit level
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - lipid profile
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - Potassium
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - Natrium
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - creatinine
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - CRP
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - Aspartate aminotransferase (AST)
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - bilirubin
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - alkaline phosphatase
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - Thyreoid Stimulating Hormone (TSH)
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - p-ionized calcium
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - PTH
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - Ca ++
Time frame: Measured every four weeks through the study (for 5 months)
Safety parameters - blood sample - 25-OH vitamin D.
Time frame: Measured every four weeks through the study (for 5 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 39289825Rasmussen RS, Midttun M, Zerahn B, Pedersen M, Rashid A, Ostergren PB, Paulin TK, Podenphanth TW, Karlsson LK, Rosendahl E, Ragle AM, Vinther A, Overgaard K. Testosterone and resistance training improved physical performance and reduced fatigue in frail older men: 1 year follow-up of a randomized clinical trial. Aging Male. 2024 Dec;27(1):2403519. doi: 10.1080/13685538.2024.2403519. Epub 2024 Sep 17.
- Derived from this study: PubMed 29500160Rasmussen R, Midttun M, Kolenda T, Ragle AM, Sorensen TW, Vinther A, Zerahn B, Pedersen M, Overgaard K. Therapist-Assisted Progressive Resistance Training, Protein Supplements, and Testosterone Injections in Frail Older Men with Testosterone Deficiency: Protocol for a Randomized Placebo-Controlled Trial. JMIR Res Protoc. 2018 Mar 2;7(3):e71. doi: 10.2196/resprot.8854.
- Therapist-Assisted Progressive Resistance Training, Protein Supplements, and Testosterone Injections in Frail Older Men with Testosterone Deficiency: Protocol for a Randomized Placebo-Controlled TrialLink provided by the sponsor.
- Testosterone serum levels in elderly fall-prone men do not correlate with age or performance in the 30 seconds chair stand testLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karsten Overgaard, M.D. study director
Herlev Hospital, Neurological Department N108
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing testosterone and Progressive muscle training in people with Muscle Weakness, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stand-up-and Sit-test (time frame: up to 5 months (at study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02873559, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.