Effect of PROGRESSive Training and Teststerone in Older Frail Men

NCT02873559 | Completed Phase 2

• 1 other identifier: Ethical protocol H-16020521
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 2

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.

Conditions

Muscle Weakness

Keywords

older; frail; men; progressive muscle training; muscle training; exercise; testosterone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (35)

• Frequency and severity of falls via questionaire

  At baseline, 1 month, 5 months (at study completion)

• Balance ability,

  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)

Study Arms (4)

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

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

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

Drug: testosterone; Other: Progressive muscle training

Interventions

testosterone DRUG

Testosterone supplemented in 5 months

Testosterone; Testosterone and training

Progressive muscle training OTHER

Progressive muscle training during 4 months

Also known as: Training

Testosterone and training; Training

Eligibility Criteria

• Age: 70 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (2)

Karsten Overgaard

Hellerup, Danmark, DK-2900, Denmark

Location

Medical Dept. O, Geriatric Section

Herlev, 2730, Denmark

Location

Related Publications (2)

• 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.

  PMID: 39289825 DERIVED

• Rasmussen 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 DERIVED

Related Links

• Therapist-Assisted Progressive Resistance Training, Protein Supplements, and Testosterone Injections in Frail Older Men with Testosterone Deficiency: Protocol for a Randomized Placebo-Controlled Trial
• Testosterone serum levels in elderly fall-prone men do not correlate with age or performance in the 30 seconds chair stand test

MeSH Terms

Conditions

Muscle Weakness; Multiple Endocrine Neoplasia Type 1; Motor Activity

Interventions

Testosterone; Autogenic Training

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karsten Overgaard, M.D.

  Herlev Hospital, Neurological Department N108

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuropychologist, Ph.D., associate professor

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 19, 2016
• Study Start: November 1, 2016
• Primary Completion: March 31, 2022
• Study Completion: March 1, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)