TY - JOUR
T1 - Protocol for GET FIT Prostate
T2 - a randomized, controlled trial of group exercise training for fall prevention and functional improvements during and after treatment for prostate cancer
AU - Winters-Stone, Kerri M.
AU - Li, Fuzhong
AU - Horak, Fay
AU - Dieckmann, Nathan
AU - Hung, Arthur
AU - Amling, Christopher
AU - Beer, Tomasz M.
N1 - Funding Information:
The study is funded by a grant from the National Cancer Institute 1R01CA222605-01A1 to Dr. Winters-Stone. The funders do not have a direct role in design of the study and collection, analysis, or interpretation of data.
Funding Information:
The authors wish to acknowledge the Oregon State Cancer Registry at the Oregon Health Authority for their collaboration on recruitment for the trial. The authors also express their appreciation to Dr. Bryan Loy for writing assistance with the initial draft of the manuscript.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: Many prostate cancer survivors are treated with androgen deprivation therapy (ADT), but these therapies may increase frailty, worsen physical functioning, and increase fall risk. While exercise may counter functional declines associated with ADT, no studies have tested whether and which type of exercise may reduce falls and frailty. The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty, and physical functioning in men expose to ADT for prostate cancer. Methods: Prostate cancer survivors treated with ADT (N = 360) who have fallen in the past year or are at risk of a fall based on validated risk factors will be recruited to participate in this single-blind, parallel group, randomized trial. Participants will be randomized to one of three supervised, group training programs: (i) strength training, (ii) tai ji quan training, or (iii) stretching (control), that train 3×/week for 6 months. Outcomes are assessed at baseline, 3 (mid-intervention), 6 (immediately post-intervention), and 12 (follow-up) months. The primary outcome is falls assessed by monthly self-report. Secondary outcomes include the following: frailty (low lean body mass (by bioelectrical impedance analysis), exhaustion (by SF-36 vitality scale), low activity (by CHAMPS physical activity survey), slowness (by 4 m usual walk speed), and weakness (by chair stand time)); objective and subjective measures of physical function will also be collected. Negative binomial regression models will be used to assess differences in falls between groups, while mixed effects modeling will be used to compare the relative efficacy of training group on secondary outcomes. Discussion: Exercise represents a non-pharmacologic approach to mitigate the problem of falls experienced among men treated with ADT. By engaging in appropriate exercise, men may be able to avoid or delay falls, frailty, and disability associated with their cancer treatment. Findings of the trial are expected to inform clinical practice about how exercise could be prescribed as part of cancer care for prostate cancer survivors prescribed ADT. Trial registration: ClinicalTrials.gov NCT03741335. Registered on November 18, 2018.
AB - Background: Many prostate cancer survivors are treated with androgen deprivation therapy (ADT), but these therapies may increase frailty, worsen physical functioning, and increase fall risk. While exercise may counter functional declines associated with ADT, no studies have tested whether and which type of exercise may reduce falls and frailty. The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty, and physical functioning in men expose to ADT for prostate cancer. Methods: Prostate cancer survivors treated with ADT (N = 360) who have fallen in the past year or are at risk of a fall based on validated risk factors will be recruited to participate in this single-blind, parallel group, randomized trial. Participants will be randomized to one of three supervised, group training programs: (i) strength training, (ii) tai ji quan training, or (iii) stretching (control), that train 3×/week for 6 months. Outcomes are assessed at baseline, 3 (mid-intervention), 6 (immediately post-intervention), and 12 (follow-up) months. The primary outcome is falls assessed by monthly self-report. Secondary outcomes include the following: frailty (low lean body mass (by bioelectrical impedance analysis), exhaustion (by SF-36 vitality scale), low activity (by CHAMPS physical activity survey), slowness (by 4 m usual walk speed), and weakness (by chair stand time)); objective and subjective measures of physical function will also be collected. Negative binomial regression models will be used to assess differences in falls between groups, while mixed effects modeling will be used to compare the relative efficacy of training group on secondary outcomes. Discussion: Exercise represents a non-pharmacologic approach to mitigate the problem of falls experienced among men treated with ADT. By engaging in appropriate exercise, men may be able to avoid or delay falls, frailty, and disability associated with their cancer treatment. Findings of the trial are expected to inform clinical practice about how exercise could be prescribed as part of cancer care for prostate cancer survivors prescribed ADT. Trial registration: ClinicalTrials.gov NCT03741335. Registered on November 18, 2018.
KW - Exercise
KW - Falls
KW - Frailty
KW - Physical activity
KW - Prostate cancer
UR - http://www.scopus.com/inward/record.url?scp=85118595498&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85118595498&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05687-7
DO - 10.1186/s13063-021-05687-7
M3 - Article
C2 - 34742325
AN - SCOPUS:85118595498
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 775
ER -