TY - JOUR
T1 - A randomized controlled trial to investigate the effects of intra-dialytic cycling on left ventricular mass
AU - Graham-Brown, Matthew P.M.
AU - March, Daniel S.
AU - Young, Robin
AU - Highton, Patrick J.
AU - Young, Hannah M.L.
AU - Churchward, Darren R.
AU - Dungey, Maurice
AU - Stensel, David J.
AU - Bishop, Nicolette C.
AU - Brunskill, Nigel J.
AU - Smith, Alice C.
AU - McCann, Gerry P.
AU - McConnachie, Alex
AU - Burton, James O.
N1 - Funding Information:
An abstract that included some of the data in this article was presented at American Society of Nephrology Kidney Week 2019 (abstract number SA-ORO64). This work falls under the portfolio of research conducted within the National Institute of Health Research (NIHR) Leicester Biomedical Research Centre. This article presents independent research funded by the NIHR in the United Kingdom (grant reference number CS-2013-13-014; JOB) and supported by Kidney Research UK. The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. After the award of funding, the funder (NIHR) did not have any input into trial design, data collection, data analysis, data interpretation, in writing the report, or in deciding to submit for publication. This research has no relationship with industry.
Funding Information:
An abstract that included some of the data in this article was presented at American Society of Nephrology Kidney Week 2019 (abstract number SA-ORO64). This work falls under the portfolio of research conducted within the National Institute of Health Research (NIHR) Leicester Biomedical Research Centre. This article presents independent research funded by the NIHR in the United Kingdom (grant reference number CS-2013-13-014; JOB) and supported by Kidney Research UK . The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. After the award of funding, the funder ( NIHR ) did not have any input into trial design, data collection, data analysis, data interpretation, in writing the report, or in deciding to submit for publication. This research has no relationship with industry.
Publisher Copyright:
© 2021 International Society of Nephrology
PY - 2021/6
Y1 - 2021/6
N2 - Cardiovascular disease is the leading cause of death for patients receiving hemodialysis. Since exercise mitigates many risk factors which drive cardiovascular disease for these patients, we assessed effects of a program of intra-dialytic cycling on left ventricular mass and other prognostically relevant measures of cardiovascular disease as evaluated by cardiac MRI (the CYCLE-HD trial). This was a prospective, open-label, single-blinded cluster-randomized controlled trial powered to detect a 15g difference in left ventricular mass measured between patients undergoing a six-month program of intra-dialytic cycling (exercise group) and patients continuing usual care (control group). Pre-specified secondary outcomes included measures of myocardial fibrosis, aortic stiffness, physical functioning, quality of life and ventricular arrhythmias. Outcomes were analyzed as intention-to-treat according to a pre-specified statistical analysis plan. Initially, 130 individuals were recruited and completed baseline assessments (65 each group). Ultimately, 101 patients completed the trial protocol (50 control group and 51 exercise group). The six-month program of intra-dialytic cycling resulted in a significant reduction in left ventricular mass between groups (-11.1g; 95% confidence interval -15.79, -6.43), which remained significant on sensitivity analysis (missing data imputed) (-9.92g; 14.68, -5.16). There were significant reductions in both native T1 mapping and aortic pulse wave velocity between groups favoring the intervention. There was no increase in either ventricular ectopic beats or complex ventricular arrhythmias as a result of exercise with no significant effect on physical function or quality of life. Thus, a six-month program of intradialytic cycling reduces left ventricular mass and is safe, deliverable and well tolerated.
AB - Cardiovascular disease is the leading cause of death for patients receiving hemodialysis. Since exercise mitigates many risk factors which drive cardiovascular disease for these patients, we assessed effects of a program of intra-dialytic cycling on left ventricular mass and other prognostically relevant measures of cardiovascular disease as evaluated by cardiac MRI (the CYCLE-HD trial). This was a prospective, open-label, single-blinded cluster-randomized controlled trial powered to detect a 15g difference in left ventricular mass measured between patients undergoing a six-month program of intra-dialytic cycling (exercise group) and patients continuing usual care (control group). Pre-specified secondary outcomes included measures of myocardial fibrosis, aortic stiffness, physical functioning, quality of life and ventricular arrhythmias. Outcomes were analyzed as intention-to-treat according to a pre-specified statistical analysis plan. Initially, 130 individuals were recruited and completed baseline assessments (65 each group). Ultimately, 101 patients completed the trial protocol (50 control group and 51 exercise group). The six-month program of intra-dialytic cycling resulted in a significant reduction in left ventricular mass between groups (-11.1g; 95% confidence interval -15.79, -6.43), which remained significant on sensitivity analysis (missing data imputed) (-9.92g; 14.68, -5.16). There were significant reductions in both native T1 mapping and aortic pulse wave velocity between groups favoring the intervention. There was no increase in either ventricular ectopic beats or complex ventricular arrhythmias as a result of exercise with no significant effect on physical function or quality of life. Thus, a six-month program of intradialytic cycling reduces left ventricular mass and is safe, deliverable and well tolerated.
KW - cardiac MRI
KW - cardiovascular disease
KW - hemodialysis
KW - intradialytic exercise
UR - http://www.scopus.com/inward/record.url?scp=85105003187&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85105003187&partnerID=8YFLogxK
U2 - 10.1016/j.kint.2021.02.027
DO - 10.1016/j.kint.2021.02.027
M3 - Article
C2 - 34023029
AN - SCOPUS:85105003187
SN - 0085-2538
VL - 99
SP - 1478
EP - 1486
JO - Kidney International
JF - Kidney International
IS - 6
ER -