Abstract
Background
This randomised controlled trial (RCT) assessed the effect of a 1-year, partially supervised, physical activity (PA) intervention on a cardiovascular disease (CVD) risk score in adult survivors of childhood cancer.
Methods
We included childhood cancer survivors ≥16 y at enrolment, <16 y at diagnosis and ≥5 y in remission. The intervention group was asked to perform an additional ≥2.5 h of intense physical activity/week, controls continued exercise as usual; assessments were performed at baseline, 6 months (T6) and 12 months (T12). The primary endpoint was change in a CVD risk score (average z-score of waist circumference, blood pressure, fasting glucose, inverted high-density lipoprotein cholesterol, triglycerides, and inverted cardiorespiratory fitness) from baseline to T12. We performed intention-to-treat (ITT, primary) and 3 per protocol analyses.
Results
We randomised 151 survivors (44% females, 30.4 ± 8.6 years). We found a significant and robust reduction of the CVD risk score in the intervention compared to the control group at T6 and T12 across all analyses; with a difference in the reduction of the CVD risk z-score of −0.18 (95% confidence interval −0.29 to −0.06, P = 0.003) at T12 in favour of the intervention group (ITT analysis).
Conclusions
This RCT showed that a long-term PA intervention can reduce CVD risk in long-term survivors of childhood cancer.
Trial registration
Clinicaltrials.gov: NCT02730767.
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Data availability
De-identified individual participant data that underlie the results reported in this article, statistical programmes (Stata do-files) and data dictionary are available upon request to the corresponding author, immediately following publication and without end date, to anyone who provides a sound proposal. The study protocol, statistical analysis plan, patient information and informed consent forms are published at the Open Science Framework platform: https://osf.io/w6j4y/.
Code availability
Statistical programmes (Stata do-files) and data dictionary are available upon request to the corresponding author, immediately following publication and without end date, to anyone who provides a sound proposal. The study protocol, statistical analysis plan, patient information and informed consent forms are published at the Open Science Framework platform: https://osf.io/w6j4y/.
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Acknowledgements
We thank all participants for taking part in our study. We thank the study nurses, assistants, master students and physiotherapists for their great work within the study.
Funding
This work was supported by the Swiss Cancer League (KLS-3175-02-2013), the “Stiftung für krebskranke Kinder, Regio Basiliensis”, “Gedächtnis-Stiftung Susy Rückert zur Krebsbekämpfung”, “Taecker-Stiftung für Krebsforschung”, “Stiftung Henriette & Hans-Rudolf Dubach-Bucher”, “Stiftung zur Krebsbekämpfung”, “Stiftung Krebs-Hilfe Zürich”, “Fondation Recherche sur le Cancer de l’Enfant (FORCE)”, and Fond’Action contre le Cancer. CSR has received funding from the European Union Seventh Framework Programme (FP7-PEOPLE-2013-COFUND) under grant agreement n°609020-Scientia Fellows. WHD is paid by a research grant from the South-Eastern Norway Regional Health Authority (grant number 2019039, to CSR). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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Conceptualisation: SK, NXvdW and CSR; data curation: CSR, RJ and SJZ; formal analysis: CSR; funding acquisition: SK, CSR and NXvdW; investigation: SJZ, CS, RJ, IB and SK; methodology: CSR, SK, SJZ, CS, RJ and NXvdW; project administration: CSR, SJZ, CS, RJ, IB, NXvdW and SK; resources: NXvdW; software: JS, RJ, CSR and SJZ; supervision: CSR, NXvdW and SK; validation: SK, CSR, IB and RJ; visualisation: CSR; writing—original draft: CSR; writing—review and editing: all authors.
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The study was performed in accordance with the Declaration of Helsinki and approved by the Swiss Ethics Committee on research involving humans (Ethikkommision Nordwest-und Zentralschweiz [EKNZ], EKNZ-2015-169). Informed consent as documented by signature, was obtained from each survivor prior to participation in the study. Data protection is assured by pseudonymization and secure storage of sensitive data.
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Rueegg, C.S., Zürcher, S.J., Schindera, C. et al. Effect of a 1-year physical activity intervention on cardiovascular health in long-term childhood cancer survivors—a randomised controlled trial (SURfit). Br J Cancer 129, 1284–1297 (2023). https://doi.org/10.1038/s41416-023-02410-y
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DOI: https://doi.org/10.1038/s41416-023-02410-y
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