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Journal article
Testosterone treatment combined with exercise to improve muscle strength, physical function and quality of life in men affected by inclusion body myositis: A randomised, double-blind, placebo-controlled, crossover trial
PloS one, Vol.18(4), Art. e0283394
2023
PMID: 37040372
Abstract
Introduction
Inclusion body myositis (IBM) is the most commonly acquired skeletal muscle disease of older adults involving both autoimmune attack and muscle degeneration. As exercise training can improve outcomes in IBM, this study assessed whether a combination of testosterone supplementation and exercise training would improve muscle strength, physical function and quality of life in men affected by IBM, more than exercise alone.
Methods
This pilot study was a single site randomised, double-blind, placebo-controlled, crossover study. Testosterone (exercise and testosterone cream) and placebo (exercise and placebo cream) were each delivered for 12 weeks, with a two-week wash-out between the two periods. The primary outcome measure was improvement in quadriceps isokinetic muscle strength. Secondary outcomes included assessment of isokinetic peak flexion force, walk capacity and patient reported outcomes, and other tests, comparing results between the placebo and testosterone arms. A 12-month Open Label Extension (OLE) was offered using the same outcome measures collected at 6 and 12-months.
Results
14 men completed the trial. There were no significant improvements in quadriceps extension strength or lean body mass, nor any of the secondary outcomes. Improvement in the RAND Short Form 36 patient reported outcome questionnaire ‘emotional wellbeing’ sub-category was reported during the testosterone arm compared to the placebo arm (mean difference [95% CI]: 6.0 points, [95% CI 1.7,10.3]). The OLE demonstrated relative disease stability over the 12-month period but with a higher number of testosterone-related adverse events.
Conclusions
Adding testosterone supplementation to exercise training did not significantly improve muscle strength or physical function over a 12-week intervention period, compared to exercise alone. However, the combination improved emotional well-being over this period, and relative stabilisation of disease was found during the 12-month OLE. A longer duration trial involving a larger group of participants is warranted.
Details
- Title
- Testosterone treatment combined with exercise to improve muscle strength, physical function and quality of life in men affected by inclusion body myositis: A randomised, double-blind, placebo-controlled, crossover trial
- Authors/Creators
- Sophia G Connor - Royal Perth HospitalTimothy J Fairchild - Murdoch University, Centre for Molecular Medicine and Innovative TherapeuticsYvonne C Learmonth - Murdoch University, Centre for Molecular Medicine and Innovative TherapeuticsKelly Beer - Perron Institute for Neurological and Translational ScienceIan Cooper - Perron Institute of Neurological and Translational Sciences, Nedlands, Western Australia, AustraliaGlenn Boardman - Fiona Stanley HospitalShaun Y M Teo - Murdoch University, School of Allied HealthBehnaz Shatahmasseb - Murdoch UniversityRui Zhang - Pathwest Laboratory MedicineKrystyne Hiscock - Affinity Clinical Research, Nedlands, Western Australia, AustraliaJerome D Coudert - Murdoch University, Centre for Molecular Medicine and Innovative TherapeuticsBu B Yeap - Fiona Stanley HospitalMerrilee Needham - Murdoch University, Centre for Molecular Medicine and Innovative Therapeutics
- Publication Details
- PloS one, Vol.18(4), Art. e0283394
- Publisher
- PLOS
- Identifiers
- 991005571669507891
- Copyright
- © 2023 Connor et al.
- Murdoch Affiliation
- Centre for Molecular Medicine and Innovative Therapeutics; School of Allied Health
- Language
- English
- Resource Type
- Journal article
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- Collaboration types
- Domestic collaboration
- Citation topics
- 1 Clinical & Life Sciences
- 1.106 Rheumatology
- 1.106.1684 Dermatomyositis
- Web Of Science research areas
- Multidisciplinary Sciences
- ESI research areas
- Clinical Medicine