TY - JOUR
T1 - Experimental protocol of a randomized controlled clinical trial investigating the effects of personalized exercise rehabilitation on kidney transplant recipients' outcomes
AU - Kastelz, Alexandra
AU - Tzvetanov, Ivo G.
AU - Fernhall, Bo
AU - Shetty, Aneesha
AU - Gallon, Lorenzo
AU - West-Thielke, Patricia
AU - Hachaj, Greg
AU - Grazman, Mark
AU - Benedetti, Enrico
N1 - Publisher Copyright:
© 2015 Elsevier Inc.
PY - 2015/11/1
Y1 - 2015/11/1
N2 - Background: This randomized controlled trial (RCT) will investigate the effects of a personalized exercise rehabilitation regimen on return to work and find work rate, vascular health, functional capacity, quality of life, kidney function, and body composition in kidney transplant (KT) recipients. Methods/design: This RCT will recruit 120 men and/or women who have had a KT to participate in a 12. month exercise intervention or control (standard clinical care only) group. The 12. month exercise intervention will consist of one-on-one, progressive exercise rehabilitation sessions twice a week, for 60. min each session. The control group will continue standard clinical care as recommended by their post-transplant medical team without any intervention. The primary outcomes will be assessments of vascular structure and function, walking and strength measures to assess functional capacity, blood markers to assess kidney function, questionnaires to assess quality of life, DXA body scan to assess body composition, and a 1-week free living physical activity assessment. Additionally, employment status will be assessed. These assessments will be performed at baseline, 6. months, and 12. months. Discussion: This investigation will increase the understanding of the role exercise rehabilitation has on managing the physiological and psychological health of the individual as well as on the individual's personal economic impact (via employment status). This study design has the potential to assist in constructing an effective exercise rehabilitation program that can be incorporated into part of standard post-transplant care.
AB - Background: This randomized controlled trial (RCT) will investigate the effects of a personalized exercise rehabilitation regimen on return to work and find work rate, vascular health, functional capacity, quality of life, kidney function, and body composition in kidney transplant (KT) recipients. Methods/design: This RCT will recruit 120 men and/or women who have had a KT to participate in a 12. month exercise intervention or control (standard clinical care only) group. The 12. month exercise intervention will consist of one-on-one, progressive exercise rehabilitation sessions twice a week, for 60. min each session. The control group will continue standard clinical care as recommended by their post-transplant medical team without any intervention. The primary outcomes will be assessments of vascular structure and function, walking and strength measures to assess functional capacity, blood markers to assess kidney function, questionnaires to assess quality of life, DXA body scan to assess body composition, and a 1-week free living physical activity assessment. Additionally, employment status will be assessed. These assessments will be performed at baseline, 6. months, and 12. months. Discussion: This investigation will increase the understanding of the role exercise rehabilitation has on managing the physiological and psychological health of the individual as well as on the individual's personal economic impact (via employment status). This study design has the potential to assist in constructing an effective exercise rehabilitation program that can be incorporated into part of standard post-transplant care.
KW - Employment
KW - Exercise rehabilitation
KW - Kidney function
KW - Kidney transplant
KW - Physical activity
KW - Vascular health
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U2 - 10.1016/j.cct.2015.10.002
DO - 10.1016/j.cct.2015.10.002
M3 - Article
C2 - 26475662
AN - SCOPUS:84946554865
SN - 1551-7144
VL - 45
SP - 170
EP - 176
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -