Clinical trial · Interventional
Effect of PROGRESSive Training and Teststerone in Older Frail Men
Effect of PROGRESSive Resistance Training, Protein Supplements and Testosterone in Older Frail Men With Testosterone Deficiency (PROGRESS Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle Weakness | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Progressive muscle training | Other | — | UNRESOLVED |
| testosterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Controls
- description
- A control group, which is 20 weeks with placebo injections without training.
- type
- EXPERIMENTAL
- label
- Testosterone
- description
- A testosterone group given 20 weeks on testosterone injections without training
- interventionNames
- Drug: testosterone
- type
- EXPERIMENTAL
- label
- Training
- description
- A Training Group, which is 20 weeks with placebo injections and 16 weeks of progressive resistance training supplemented with vitamin D and protein supplements
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDRasmussen 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. PMID 39289825
- DERIVEDRasmussen 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. PMID 29500160