TY - JOUR
T1 - The efficacy of a blended intervention to improve physical activity and protein intake for optimal physical recovery after oncological gastrointestinal and lung cancer surgery, the Optimal Physical Recovery After Hospitalization (OPRAH) trial
T2 - study protocol for a randomized controlled multicenter trial
AU - de Leeuwerk, Marijke
AU - de Groot, Vincent
AU - Dam, Suzanne ten
AU - Kruizenga, Hinke
AU - Weijs, Peter
AU - Geleijn, Edwin
AU - van der Leeden, Marike
AU - van der Schaaf, Marike
AU - Dickhoff, Chris
AU - Besselink, Marc G.
AU - Tuynman, Jurriaan B.
AU - van Berge Henegouwen, Mark I.
AU - Erdmann, Joris I.
AU - Huijsmans, Rosalie J.
AU - van der Ploeg, Hidde P.
AU - Eskes, Anne M.
AU - Pijnappels, Mirjam A. G. M.
AU - van Leeuwen, Liesbeth Schuijs
AU - Smits, Anke B.
AU - van Dijk, Jasmijn
AU - Grimbergen, Eva
AU - OPRAH consortium
N1 - Funding Information: Supplementary information Composition, roles and responsibilities of the coordinating center, OPRAH consortium, Medical Ethics Committee and ORPAH research group. Coordinating center Amsterdam UMC, location VUmc, is the coordinating center of this trial. Therefore, they are responsible for the participant recruitment, data collection, and data analysis. Amsterdam UMC, location VUmc, is also the owner of the medical devices used in this trial (movement sensors and associated software) and therefore maintains the management of these devices. MdL is mainly responsible for this. OPRAH consortium The OPRAH consortium is a multidisciplinary group that aims to provide expert advice and monitor the progress during the preparation and execution of the trial. Please refer to the author list for the members of the OPRAH consortium. Meetings are held twice a year, and more frequently if deemed necessary. Medical Ethics Committee (MEC) The MEC of Amsterdam UMC, VUmc location, is an independent multidisciplinary group that monitors the safety and effectiveness of the trial and oversees the overall conduct of the study. The Data Monitoring Center (DMC) supports clinical researchers in ensuring compliance with relevant laws and regulatory requirements, such as WMO, ICH-GCP, and/or ISO14155. During the trial, there will be four on-site monitoring visits at Amsterdam UMC, VUmc location, and three monitoring visits at St. Antonius Hospital, Nieuwegein. Both sites will have a close-out visit after the last subject visit. OPRAH research group The OPRAH research group is responsible for the management of the trial and will be led by MdL, the executive researcher of the OPRAH study. Other members of the Trial management group include MvdL (principal investigator), MvdS (principal investigator), EG (innovator and physiotherapist), StD (dietician-researcher), and HK (dietician-researcher). The OPRAH research group will meet approximately once a month to oversee the day-to-day management of the trial. Publisher Copyright: © 2023, The Author(s).
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Background: Improving physical activity, especially in combination with optimizing protein intake, after surgery has a potential positive effect on recovery of physical functioning in patients after gastrointestinal and lung cancer surgery. The aim of this randomized controlled trial is to evaluate the efficacy of a blended intervention to improve physical activity and protein intake after hospital discharge on recovery of physical functioning in these patients. Methods: In this multicenter single-blinded randomized controlled trial, 161 adult patients scheduled for elective gastrointestinal or lung cancer surgery will be randomly assigned to the intervention or control group. The purpose of the Optimal Physical Recovery After Hospitalization (OPRAH) intervention is to encourage self-management of patients in their functional recovery, by using a smartphone application and corresponding accelerometer in combination with coaching by a physiotherapist and dietician during three months after hospital discharge. Study outcomes will be measured prior to surgery (baseline) and one, four, eight, and twelve weeks and six months after hospital discharge. The primary outcome is recovery in physical functioning six months after surgery, and the most important secondary outcome is physical activity. Other outcomes include lean body mass, muscle mass, protein intake, symptoms, physical performance, self-reported limitations in activities and participation, self-efficacy, hospital readmissions and adverse events. Discussion: The results of this study will demonstrate whether a blended intervention to support patients increasing their level of physical activity and protein intake after hospital discharge improves recovery in physical functioning in patients after gastrointestinal and lung cancer surgery. Trial registration: The trial has been registered at the International Clinical Trials Registry Platform at 14–10-2021 with registration number NL9793. Trial registration data are presented in Table 1.
AB - Background: Improving physical activity, especially in combination with optimizing protein intake, after surgery has a potential positive effect on recovery of physical functioning in patients after gastrointestinal and lung cancer surgery. The aim of this randomized controlled trial is to evaluate the efficacy of a blended intervention to improve physical activity and protein intake after hospital discharge on recovery of physical functioning in these patients. Methods: In this multicenter single-blinded randomized controlled trial, 161 adult patients scheduled for elective gastrointestinal or lung cancer surgery will be randomly assigned to the intervention or control group. The purpose of the Optimal Physical Recovery After Hospitalization (OPRAH) intervention is to encourage self-management of patients in their functional recovery, by using a smartphone application and corresponding accelerometer in combination with coaching by a physiotherapist and dietician during three months after hospital discharge. Study outcomes will be measured prior to surgery (baseline) and one, four, eight, and twelve weeks and six months after hospital discharge. The primary outcome is recovery in physical functioning six months after surgery, and the most important secondary outcome is physical activity. Other outcomes include lean body mass, muscle mass, protein intake, symptoms, physical performance, self-reported limitations in activities and participation, self-efficacy, hospital readmissions and adverse events. Discussion: The results of this study will demonstrate whether a blended intervention to support patients increasing their level of physical activity and protein intake after hospital discharge improves recovery in physical functioning in patients after gastrointestinal and lung cancer surgery. Trial registration: The trial has been registered at the International Clinical Trials Registry Platform at 14–10-2021 with registration number NL9793. Trial registration data are presented in Table 1.
KW - Adult
KW - Cancer
KW - Exercise
KW - Hospitalization
KW - Humans
KW - Lung Neoplasms/surgery
KW - Mobile Applications
KW - Multicenter Studies as Topic
KW - Physical activity
KW - Physical functioning
KW - Protein intake
KW - Randomized Controlled Trials as Topic
KW - Supportive care
KW - Surgery
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85177800871&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-023-07705-2
DO - https://doi.org/10.1186/s13063-023-07705-2
M3 - Article
C2 - 38008734
SN - 1745-6215
VL - 24
SP - 757
JO - Trials
JF - Trials
IS - 1
M1 - 757
ER -