Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438484
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-05-15
Brief Title:
The Challenges of Evidence-based Prehabilitation in a Real-life Context for Patients Preparing for Colorectal Surgery
Sponsor:
Nij Smellinghe Hosptial
Organization:
Nij Smellinghe Hosptial
Study Overview
Official Title:
The Challenges of Evidence-based Prehabilitation in a Real-life Context for Patients Preparing for Colorectal Surgery - a Cohort Study and Multiple Case Analysis
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Multimodal prehabilitation programs are effective in reducing complications after colorectal surgery in patients with high risk of postoperative complications due to low aerobic capacity andor malnutrition However high implementation fidelity is needed to achieve these effects in real-life practice Therefore this study aimed to investigate the implementation fidelity of an evidence-based prehabilitation program in the real-life context of a regional hospital
Methods In this observational cohort study with multiple case analysis we enrolled all patients who underwent surgery for colorectal cancer from January 2023 to June 2023 in one Dutch peripheral hospital Patients meeting criteria for low aerobic capacity or malnutrition were advised to participate in a personalized prehabilitation program Implementation fidelity was investigated on four domains 1 coverage participation rate 2 duration number of days following the prehabilitation program 3 content delivery of prescribed intervention modalities and 4 frequency attendance of sessions and compliance with prescribed parameters An aggregated percentage of content and frequency was calculated to determine overall adherence The intended outcomes were improvement in preoperative aerobic capacity and malnutrition and improved postoperative recovery ie reducing complications length of stay and time to functional recovery
Methods In this observational cohort study with multiple case analysis we enrolled all patients who underwent surgery for colorectal cancer from January 2023 to June 2023 in one Dutch peripheral hospital Patients meeting criteria for low aerobic capacity or malnutrition were advised to participate in a personalized prehabilitation program Implementation fidelity was investigated on four domains 1 coverage participation rate 2 duration number of days following the prehabilitation program 3 content delivery of prescribed intervention modalities and 4 frequency attendance of sessions and compliance with prescribed parameters An aggregated percentage of content and frequency was calculated to determine overall adherence The intended outcomes were improvement in preoperative aerobic capacity and malnutrition and improved postoperative recovery ie reducing complications length of stay and time to functional recovery
Detailed Description:
Study design and patients This observational cohort study was conducted from January 2023 to June 2023 with case analysis on the high-risk patients following the prehabilitation program in Nij Smellinghe NS The study was approved by the Local Ethic Committee of NS The first author was a physiotherapist who acted as an embedded scientist in the colorectal pathway25 For the period of this study only one physiotherapist and dietitian performed the prehabilitation program to prevent provider-dependent bias All patients both high-risk and low-risk of 18 years or older scheduled for elective colorectal surgery in NS were asked for their informed consent to be included in the cohort No exclusion criteria were applied The STrengthening the Reporting of Observational Studies in Epidemiology STROBE guideline for reporting observational studies was followed26
Study setting NS is a regional hospital with 339 beds in The Netherlands where annually 150 patients undergo colorectal surgery27 NS is an innovative hospital in the field of perioperative care and the Enhanced Recovery After Surgery ERAS protocol has been implemented into usual care since 201828 In January 2023 following new scientific insights an evidence-based multimodal prehabilitation program was implemented in the colorectal pathway This pathway included assessment of patients on their risk of postoperative complications and offering a multimodal prehabilitation program for high-risk patients
Preoperative risk assessment When patients were indicated for colorectal surgery a physiotherapist and dietitian conducted risk assessment for postoperative complications Patients meeting criteria for low aerobic capacity andor high risk of malnutrition were advised to participate in a personalized prehabilitation program229
The physiotherapist assessed aerobic capacity Aerobic capacity was measured by the cardiopulmonary exercise test CPET or modified steep ramp test SRT following the protocol of previous research on preoperative risk assessment21530 Patients with a low aerobic capacity indicated by a work at peak exercise achieved at the modified SRT 15Wkg or an oxygen uptake at the VAT 11mLkgmin at the CPET were indicated as high-risk patients
The dietitian evaluated risk of malnutrition by using the Patient-Generated Subjective Global Assessment Short Form PG-SGA SF Based on the Global Leadership Initiative on Malnutrition GLIM criteria patients were diagnosed with malnutrition thus indicating the nutrition-modality of prehabilitation31 According to the GLIM-criteria malnutrition is defined as the presence of one phenotypic criterion non-volitional weight loss low body mass index and reduced muscle mass and one etiologic criterion reduced food intake or assimilation and inflammation or disease burden32 Muscle mass and body composition was assessed with the bioelectrical impedance analysis BIA Bodygram Plus Akern Italy
Patients with high-risk profile multimodal prehabilitation program High-risk patients followed an evidence-based multimodal prehabilitation program for five weeks incorporating modalities tailored to address their impairments21215 Patients performed physical exercise training andor received dietary counseling for five weeks provided by a trained physiotherapist and dietitian both 15 years experience The physical exercise training consisted of high-intensity interval training HIIT three times a week and functional strengthening exercises Patients visited the hospital two times a week and performed home exercise training five times a week on a stationary cycle ergometer Corival Home Lode BV Groningen The Netherlands
The dietary intervention consisted of optimization of energy and protein intake optimization of timing of eating protein-rich products and if necessary additional protein and vitamin supplements Individual protein requirements were set at 15-19 gkg fat free mass Patients used the eiFIT-application or a food diary to track their protein intake33
Treating patients with low hemoglobin levels offering alcohol- and smoking cessation interventions and giving psychological support were also elements of the prehabilitation program in NS However this is already part of usual care since implementation of the ERAS-protocol and therefore not specifically evaluated in this study A detailed description of the complete pathway is provided in Appendix 1
Statistical analysis All data were analyzed using descriptive statistics For patient characteristics continuous data were tested for normality by the Shapiro-Wilk test and QQ-plot Median and interquartile range IQR or mean and standard deviation were reported accordingly To report the fidelity of the prehabilitation program absolute values and percentages were given To prevent selection bias NS reimbursed the expenses of prehabilitation for people who otherwise could not afford it as insurance companies did not reimburse prehabilitation in The Netherlands during the study period Data were analyzed using R Framework 422 for macOS version 2022 Vienna42
Study setting NS is a regional hospital with 339 beds in The Netherlands where annually 150 patients undergo colorectal surgery27 NS is an innovative hospital in the field of perioperative care and the Enhanced Recovery After Surgery ERAS protocol has been implemented into usual care since 201828 In January 2023 following new scientific insights an evidence-based multimodal prehabilitation program was implemented in the colorectal pathway This pathway included assessment of patients on their risk of postoperative complications and offering a multimodal prehabilitation program for high-risk patients
Preoperative risk assessment When patients were indicated for colorectal surgery a physiotherapist and dietitian conducted risk assessment for postoperative complications Patients meeting criteria for low aerobic capacity andor high risk of malnutrition were advised to participate in a personalized prehabilitation program229
The physiotherapist assessed aerobic capacity Aerobic capacity was measured by the cardiopulmonary exercise test CPET or modified steep ramp test SRT following the protocol of previous research on preoperative risk assessment21530 Patients with a low aerobic capacity indicated by a work at peak exercise achieved at the modified SRT 15Wkg or an oxygen uptake at the VAT 11mLkgmin at the CPET were indicated as high-risk patients
The dietitian evaluated risk of malnutrition by using the Patient-Generated Subjective Global Assessment Short Form PG-SGA SF Based on the Global Leadership Initiative on Malnutrition GLIM criteria patients were diagnosed with malnutrition thus indicating the nutrition-modality of prehabilitation31 According to the GLIM-criteria malnutrition is defined as the presence of one phenotypic criterion non-volitional weight loss low body mass index and reduced muscle mass and one etiologic criterion reduced food intake or assimilation and inflammation or disease burden32 Muscle mass and body composition was assessed with the bioelectrical impedance analysis BIA Bodygram Plus Akern Italy
Patients with high-risk profile multimodal prehabilitation program High-risk patients followed an evidence-based multimodal prehabilitation program for five weeks incorporating modalities tailored to address their impairments21215 Patients performed physical exercise training andor received dietary counseling for five weeks provided by a trained physiotherapist and dietitian both 15 years experience The physical exercise training consisted of high-intensity interval training HIIT three times a week and functional strengthening exercises Patients visited the hospital two times a week and performed home exercise training five times a week on a stationary cycle ergometer Corival Home Lode BV Groningen The Netherlands
The dietary intervention consisted of optimization of energy and protein intake optimization of timing of eating protein-rich products and if necessary additional protein and vitamin supplements Individual protein requirements were set at 15-19 gkg fat free mass Patients used the eiFIT-application or a food diary to track their protein intake33
Treating patients with low hemoglobin levels offering alcohol- and smoking cessation interventions and giving psychological support were also elements of the prehabilitation program in NS However this is already part of usual care since implementation of the ERAS-protocol and therefore not specifically evaluated in this study A detailed description of the complete pathway is provided in Appendix 1
Statistical analysis All data were analyzed using descriptive statistics For patient characteristics continuous data were tested for normality by the Shapiro-Wilk test and QQ-plot Median and interquartile range IQR or mean and standard deviation were reported accordingly To report the fidelity of the prehabilitation program absolute values and percentages were given To prevent selection bias NS reimbursed the expenses of prehabilitation for people who otherwise could not afford it as insurance companies did not reimburse prehabilitation in The Netherlands during the study period Data were analyzed using R Framework 422 for macOS version 2022 Vienna42
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None