TY - JOUR
T1 - The stair climb power test as an efficacy outcome in randomized trials of function promoting therapies in older men
AU - Gagliano-Jucá, Thiago
AU - Li, Zhuoying
AU - Pencina, Karol M.
AU - Traustadóttir, Tinna
AU - Travison, Thomas G.
AU - Woodhouse, Linda
AU - Basaria, Shehzad
AU - Tsitouras, Panayiotis D.
AU - Harman, S. Mitchell
AU - Bhasin, Shalender
AU - Storer, Thomas W.
N1 - Funding Information:
L.W. has served as a consultant to Eli Lilly and Scholar Rock. S.Ba. has served as a consultant to AbbVie Pharmaceuticals and Regeneron. S.Bh. has received research grant support from AbbVie Pharmaceuticals, Transition Therapeutics, Takeda Pharmaceuticals, and Eli Lilly for investigator-initiated research unrelated to this study. S.Bh. has served as a consultant to AbbVie, Regeneron, Novartis, and Eli Lilly. S.Bh. has a financial interest in Function Promoting Therapies, LLC, a company aiming to develop innovative solutions that enhance precision and accuracy in clinical decision making and facilitate personalized therapeutic choices in reproductive health. T.W.S. has served as a consultant to Regeneron Pharmaceuticals and ScholarRock. Other authors report no conflicts.
Funding Information:
The National Institutes on Aging administered the study under a cooperative agreement (1UO1AG14369). Additional support was provided by Boston Claude D. Pepper Older Americans Independence Center (5P30AG031679) and Boston University Clinical and Translational Science Institute (1UL1RR025771).
Publisher Copyright:
© The Author(s) 2019. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
PY - 2021
Y1 - 2021
N2 - Background: Standardization of performance-based physical function measures that are reliable and responsive to intervention is necessary for efficacy trials of function promoting anabolic therapies (FPTs). Herein, we describe a standardized method of measuring stair climbing power (SCP) and evaluate its ability to assess improvements in physical function in response to an FPT (testosterone) compared to gait speed. Methods: We used a 12-step SCP test with and without carrying a load (loaded, LSCP or unloaded, USCP) in two testosterone trials in older men. SCP was determined from mass, total step-rise, and time of ascent measured with an electronic timing system. Associations between SCP and leg press performance (strength and power), testosterone levels, and gait speed were assessed. Test-retest reliability was evaluated using interclass correlation and Bland-Altman analyses. Results: Baseline SCP was negatively associated with age and positively with leg strength and power and gait speed. Both tests of SCP were safe and showed excellent reliability (intra-class correlation 0.91-0.97 in both cohorts). Changes in testosterone concentrations were associated with changes in USCP and LSCP, but not gait speed in mobility-limited men. Changes in leg press performance were associated with SCP in both trials. Conclusions: Both USCP and LSCP are safe and have high test-retest reliability. Compared to gait speed, SCP is associated more robustly with leg press performance and is sensitive to testosterone therapy. The LSCP might be a more responsive outcome than gait speed to evaluate the efficacy of FPT in randomized trials.
AB - Background: Standardization of performance-based physical function measures that are reliable and responsive to intervention is necessary for efficacy trials of function promoting anabolic therapies (FPTs). Herein, we describe a standardized method of measuring stair climbing power (SCP) and evaluate its ability to assess improvements in physical function in response to an FPT (testosterone) compared to gait speed. Methods: We used a 12-step SCP test with and without carrying a load (loaded, LSCP or unloaded, USCP) in two testosterone trials in older men. SCP was determined from mass, total step-rise, and time of ascent measured with an electronic timing system. Associations between SCP and leg press performance (strength and power), testosterone levels, and gait speed were assessed. Test-retest reliability was evaluated using interclass correlation and Bland-Altman analyses. Results: Baseline SCP was negatively associated with age and positively with leg strength and power and gait speed. Both tests of SCP were safe and showed excellent reliability (intra-class correlation 0.91-0.97 in both cohorts). Changes in testosterone concentrations were associated with changes in USCP and LSCP, but not gait speed in mobility-limited men. Changes in leg press performance were associated with SCP in both trials. Conclusions: Both USCP and LSCP are safe and have high test-retest reliability. Compared to gait speed, SCP is associated more robustly with leg press performance and is sensitive to testosterone therapy. The LSCP might be a more responsive outcome than gait speed to evaluate the efficacy of FPT in randomized trials.
KW - Anabolic intervention
KW - Muscle power
KW - Physical function
KW - Testosterone
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U2 - 10.1093/GERONA/GLZ167
DO - 10.1093/GERONA/GLZ167
M3 - Article
C2 - 31282538
AN - SCOPUS:85085536160
VL - 75
SP - 1167
EP - 1175
JO - Journals of Gerontology - Series A Biological Sciences and Medical Sciences
JF - Journals of Gerontology - Series A Biological Sciences and Medical Sciences
SN - 1079-5006
IS - 6
ER -