Randomized controlled trial on the effects of a supervised high intensity exercise program in patients with a hematologic malignancy treated with autologous stem cell transplantation: Results from the EXIST study
Persoon, Saskia; Chinapaw, Mai J. M.; Buffart, Laurien M.; Liu, Roberto D.K.; Wijermans, Pierre; Koene, Harry R; Minnema, Monique C.; Lugtenburg, Pieternella J; Marijt, Erik W A; Brug, Johannes; Nollet, Frans; Kersten, Marie José
(2017) PLoS ONE [E], volume 12, issue 7, pp. 1 - 14
(Article)
Abstract
Background: This single blind, multicenter randomized controlled trial aimed to evaluate the effectiveness of a supervised high intensity exercise program on physical fitness and fatigue in patients with multiple myeloma or lymphoma recently treated with autologous stem cell transplantation. Methods: 109 patients were randomly assigned to the 18-week exercise intervention
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or the usual care control group. The primary outcomes included physical fitness (VO2peak and Wpeak determined using a cardiopulmonary exercise test; grip strength and the 30s chair stand test) and fatigue (Multidimensional Fatigue Inventory) and were assessed prior to randomization and after completion of the intervention or at similar time points for the control group. Multivariable multilevel linear regression analyses were performed to assess intervention effects. Results: Patients in the intervention group attended 86% of the prescribed exercise sessions. Of the patients in the control group, 47% reported ≥10 physiotherapy sessions, which most likely included supervised exercise, suggesting a high rate of contamination. Median improvements in physical fitness ranged between 16 and 25% in the intervention group and between 12 and 19% in the control group. Fatigue decreased in both groups. There were no significant differences between the intervention and control group. Conclusion: We found no significant beneficial effects of the supervised high intensity exercise program on physical fitness and fatigue when compared to usual care. We hypothesized that the lack of significant intervention effects may relate to suboptimal timing of intervention delivery, contamination in the control group and/or suboptimal compliance to the prescribed exercise intervention. Trial registration: Netherlands Trial Register—NTR2341.
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Keywords: Adult, Aged, Drug-Related Side Effects and Adverse Reactions/therapy, Exercise Therapy, Female, High-Intensity Interval Training, Humans, Lymphoma/drug therapy, Male, Middle Aged, Multiple Myeloma/drug therapy, Physical Fitness, Single-Blind Method, General Agricultural and Biological Sciences, General Biochemistry,Genetics and Molecular Biology, Randomized Controlled Trial, Multicenter Study, Journal Article
ISSN: 1932-6203
Publisher: Public Library of Science
Note: Funding Information: This study was supported by the Alpe d'HuZes/KWF Fund. The research grant was provided by the Dutch Cancer Society (Grant number: ALPE 2009-4620), http://www.kwf.nl. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This study is part of the A-CaRe Program, http://www.a-care.org. The authors acknowledge the A-CaRe Clinical Research group and thank all patients who participated in the study and all hematologists, nurses, data managers and physiotherapists who contributed to the study. We are also grateful to Karen van der Weiden, Julie Heeren, Griet van der Slagmolen, Michiel Greidanus, the team of the Sports Medical Advice Center Rotterdam and the members of the Clinical Trial Office, department of Hematology AMC for their assistance with patient recruitment, data collection and/or data analysis. Furthermore, the authors would like to acknowledge prof. dr. Jos Twisk and dr. Martijn Heymans for their statistical support. Publisher Copyright: © 2017 Persoon et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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