Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation

Thomas G. Travison, Shehzad Basaria, Thomas W. Storer, Alan M. Jette, Renee Miciek, Wildon R. Farwell, Karen Choong, Kishore Lakshman, Norman A. Mazer, Andrea D. Coviello, Philip E. Knapp, Jagadish Ulloor, Anqi Zhang, Brad Brooks, Ahn Hoa Nguyen, Richard Eder, Nathan K LeBrasseur, Ayan Elmi, Erica Appleman, Leife Hede-BrierleyGeeta Bhasin, Ashmeet Bhatia, Antonio Lazzari, Samuel Davis, Pengsheng Ni, Lauren Collins, Shalender Bhasin

Research output: Contribution to journalArticle

91 Citations (Scopus)

Abstract

Context.Testosterone in Older Men with Mobility Limitations Trial determined the effects of testosterone on muscle performance and physical function in older men with mobility limitation. Trial's Data and Safety Monitoring Board recommended enrollment cessation due to increased frequency of adverse events in testosterone arm. The changes in muscle performance and physical function were evaluated in relation to participant's perception of change.Methods.Men aged 65 years and older, with mobility limitation, total testosterone 100-350 ng/dL, or free testosterone less than 50 pg/mL, were randomized to placebo or 10 g testosterone gel daily for 6 months. Primary outcome was leg-press strength. Secondary outcomes included chest-press strength, stair-climb, 40-m walk, muscle mass, physical activity, self-reported function, and fatigue. Proportions of participants exceeding minimally important difference in study arms were compared.Results.Of 209 randomized participants, 165 had follow-up efficacy measures. Mean (SD) age was 74 (5.4) years and short physical performance battery score 7.7 (1.4). Testosterone arm exhibited greater improvements in leg-press strength, chest-press strength and power, and loaded stair-climb than placebo. Compared with placebo, significantly greater proportion of men receiving testosterone improved their leg-press and chest-press strengths (43% vs 18%, p =. 01) and stair-climbing power (28% vs 10%, p =. 03) more than minimally important difference. Increases in leg-press strength and stair-climbing power were associated with changes in testosterone levels and muscle mass. Physical activity, walking speed, self-reported function, and fatigue did not change.Conclusions.Testosterone administration in older men with mobility limitation was associated with patient-important improvements in muscle strength and stair-climbing power. Improvements in muscle strength and only some physical function measures should be weighed against the risk of adverse events in this population.

Original languageEnglish (US)
Pages (from-to)1090-1099
Number of pages10
JournalJournals of Gerontology - Series A Biological Sciences and Medical Sciences
Volume66 A
Issue number10
DOIs
StatePublished - Oct 2011
Externally publishedYes

Fingerprint

Mobility Limitation
Testosterone
Muscles
Leg
Arm
Thorax
Placebos
Muscle Strength
Fatigue
Clinical Trials Data Monitoring Committees
Exercise
Gels
Stair Climbing

Keywords

  • Function promoting therapies
  • Minimally important difference
  • Mobility limitation
  • Older men
  • Testosterone

ASJC Scopus subject areas

  • Aging
  • Geriatrics and Gerontology
  • Medicine(all)

Cite this

Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation. / Travison, Thomas G.; Basaria, Shehzad; Storer, Thomas W.; Jette, Alan M.; Miciek, Renee; Farwell, Wildon R.; Choong, Karen; Lakshman, Kishore; Mazer, Norman A.; Coviello, Andrea D.; Knapp, Philip E.; Ulloor, Jagadish; Zhang, Anqi; Brooks, Brad; Nguyen, Ahn Hoa; Eder, Richard; LeBrasseur, Nathan K; Elmi, Ayan; Appleman, Erica; Hede-Brierley, Leife; Bhasin, Geeta; Bhatia, Ashmeet; Lazzari, Antonio; Davis, Samuel; Ni, Pengsheng; Collins, Lauren; Bhasin, Shalender.

In: Journals of Gerontology - Series A Biological Sciences and Medical Sciences, Vol. 66 A, No. 10, 10.2011, p. 1090-1099.

Research output: Contribution to journalArticle

Travison, TG, Basaria, S, Storer, TW, Jette, AM, Miciek, R, Farwell, WR, Choong, K, Lakshman, K, Mazer, NA, Coviello, AD, Knapp, PE, Ulloor, J, Zhang, A, Brooks, B, Nguyen, AH, Eder, R, LeBrasseur, NK, Elmi, A, Appleman, E, Hede-Brierley, L, Bhasin, G, Bhatia, A, Lazzari, A, Davis, S, Ni, P, Collins, L & Bhasin, S 2011, 'Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation', Journals of Gerontology - Series A Biological Sciences and Medical Sciences, vol. 66 A, no. 10, pp. 1090-1099. https://doi.org/10.1093/gerona/glr100
Travison, Thomas G. ; Basaria, Shehzad ; Storer, Thomas W. ; Jette, Alan M. ; Miciek, Renee ; Farwell, Wildon R. ; Choong, Karen ; Lakshman, Kishore ; Mazer, Norman A. ; Coviello, Andrea D. ; Knapp, Philip E. ; Ulloor, Jagadish ; Zhang, Anqi ; Brooks, Brad ; Nguyen, Ahn Hoa ; Eder, Richard ; LeBrasseur, Nathan K ; Elmi, Ayan ; Appleman, Erica ; Hede-Brierley, Leife ; Bhasin, Geeta ; Bhatia, Ashmeet ; Lazzari, Antonio ; Davis, Samuel ; Ni, Pengsheng ; Collins, Lauren ; Bhasin, Shalender. / Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation. In: Journals of Gerontology - Series A Biological Sciences and Medical Sciences. 2011 ; Vol. 66 A, No. 10. pp. 1090-1099.
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AU - Travison, Thomas G.

AU - Basaria, Shehzad

AU - Storer, Thomas W.

AU - Jette, Alan M.

AU - Miciek, Renee

AU - Farwell, Wildon R.

AU - Choong, Karen

AU - Lakshman, Kishore

AU - Mazer, Norman A.

AU - Coviello, Andrea D.

AU - Knapp, Philip E.

AU - Ulloor, Jagadish

AU - Zhang, Anqi

AU - Brooks, Brad

AU - Nguyen, Ahn Hoa

AU - Eder, Richard

AU - LeBrasseur, Nathan K

AU - Elmi, Ayan

AU - Appleman, Erica

AU - Hede-Brierley, Leife

AU - Bhasin, Geeta

AU - Bhatia, Ashmeet

AU - Lazzari, Antonio

AU - Davis, Samuel

AU - Ni, Pengsheng

AU - Collins, Lauren

AU - Bhasin, Shalender

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N2 - Context.Testosterone in Older Men with Mobility Limitations Trial determined the effects of testosterone on muscle performance and physical function in older men with mobility limitation. Trial's Data and Safety Monitoring Board recommended enrollment cessation due to increased frequency of adverse events in testosterone arm. The changes in muscle performance and physical function were evaluated in relation to participant's perception of change.Methods.Men aged 65 years and older, with mobility limitation, total testosterone 100-350 ng/dL, or free testosterone less than 50 pg/mL, were randomized to placebo or 10 g testosterone gel daily for 6 months. Primary outcome was leg-press strength. Secondary outcomes included chest-press strength, stair-climb, 40-m walk, muscle mass, physical activity, self-reported function, and fatigue. Proportions of participants exceeding minimally important difference in study arms were compared.Results.Of 209 randomized participants, 165 had follow-up efficacy measures. Mean (SD) age was 74 (5.4) years and short physical performance battery score 7.7 (1.4). Testosterone arm exhibited greater improvements in leg-press strength, chest-press strength and power, and loaded stair-climb than placebo. Compared with placebo, significantly greater proportion of men receiving testosterone improved their leg-press and chest-press strengths (43% vs 18%, p =. 01) and stair-climbing power (28% vs 10%, p =. 03) more than minimally important difference. Increases in leg-press strength and stair-climbing power were associated with changes in testosterone levels and muscle mass. Physical activity, walking speed, self-reported function, and fatigue did not change.Conclusions.Testosterone administration in older men with mobility limitation was associated with patient-important improvements in muscle strength and stair-climbing power. Improvements in muscle strength and only some physical function measures should be weighed against the risk of adverse events in this population.

AB - Context.Testosterone in Older Men with Mobility Limitations Trial determined the effects of testosterone on muscle performance and physical function in older men with mobility limitation. Trial's Data and Safety Monitoring Board recommended enrollment cessation due to increased frequency of adverse events in testosterone arm. The changes in muscle performance and physical function were evaluated in relation to participant's perception of change.Methods.Men aged 65 years and older, with mobility limitation, total testosterone 100-350 ng/dL, or free testosterone less than 50 pg/mL, were randomized to placebo or 10 g testosterone gel daily for 6 months. Primary outcome was leg-press strength. Secondary outcomes included chest-press strength, stair-climb, 40-m walk, muscle mass, physical activity, self-reported function, and fatigue. Proportions of participants exceeding minimally important difference in study arms were compared.Results.Of 209 randomized participants, 165 had follow-up efficacy measures. Mean (SD) age was 74 (5.4) years and short physical performance battery score 7.7 (1.4). Testosterone arm exhibited greater improvements in leg-press strength, chest-press strength and power, and loaded stair-climb than placebo. Compared with placebo, significantly greater proportion of men receiving testosterone improved their leg-press and chest-press strengths (43% vs 18%, p =. 01) and stair-climbing power (28% vs 10%, p =. 03) more than minimally important difference. Increases in leg-press strength and stair-climbing power were associated with changes in testosterone levels and muscle mass. Physical activity, walking speed, self-reported function, and fatigue did not change.Conclusions.Testosterone administration in older men with mobility limitation was associated with patient-important improvements in muscle strength and stair-climbing power. Improvements in muscle strength and only some physical function measures should be weighed against the risk of adverse events in this population.

KW - Function promoting therapies

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