The Challenges of Evidence-based Prehabilitation in a Real-life Context for Patients Preparing for Colorectal Surgery

NCT06438484 | Completed DMC

• 1 other identifier: NUTNS
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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 and/or 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 (i.e., reducing complications, length of stay, and time to functional recovery).

Conditions

Colorectal Surgery

Keywords

Preoperative Exercise

Outcome Measures

Primary Outcomes (4)

• Coverage

  Coverage was defined as 'the participation rate in the innovation by the intended audience' and was determined as the percentage of eligible patients who were assessed and able to follow the suitable prehabilitation pathway. Reasons for drop-out and non-participation were reported.

  january 2023 - june 2023

• Duration

  , which can be subdivided into coverage, duration, content, and frequency. Duration was measured by the number of days between assessment and surgery and should be at least thirty days.

  january 2023 - june 2023

• Content

  Content was measured by the number of different components of the intervention delivered.

  january 2023 - june 2023

• Frequency

  Frequency was measured by the percentage of times when the training intensity as prescribed, time, and the days on which nutritional requirements were achieved

  january 2023 - june 2023

Secondary Outcomes (8)

• Preoperative aerobic capacity

  january 2023 - june 2023

• Preoperative nutritional status

  january 2023 - june 2023

• Complications

  january 2023 - june 2023

• Length of stay

  january 2023 - june 2023

• Time to recovery of physical functioning

  january 2023 - june 2023

Other Outcomes (9)

• patiënt characteristics, age

  january 2023 - june 2023

• patiënt characteristics, sex

  january 2023 - june 2023

• patiënt characteristics, living situation

  january 2023 - june 2023

Study Arms (2)

Low risk

Patients with high aerobic capacity and good nutritional status were given the advice to eat healthy and stay active until surgery. Postoperative data were collected for evaluative purposes.

High risk

High-risk patients followed an evidence-based multimodal prehabilitation program for five weeks, incorporating modalities tailored to address their impairments. Patients performed physical exercise training and/or received dietary counseling for five weeks, provided by a trained physiotherapist and dietitian (both \>15 years experience).

Behavioral: multimodal prehabilitation program

Interventions

multimodal prehabilitation program BEHAVIORAL

Patients performed physical exercise training and/or 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 1.5-1.9 g/kg fat free mass. Patients used the eiFIT-application or a food diary to track their protein intake.

High risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients following the prehabilitation program in Nij Smellinghe

You may qualify if:

• a patient must be awaiting CRC surgery in NS
• be 18 years or older

You may not qualify if:

• Patient data will only be excluded if they do not permit the usage of their data.

Sponsors & Collaborators

• Nij Smellinghe Hosptial: lead

Study Sites (1)

Nij Smellinghe hospital

Drachten, Provincie Friesland, 9202 NN, Netherlands

Location

Related Publications (1)

• Talen AD, van Meeteren NLU, Barten JA, Pereboom I, Krijnen WP, Jager-Wittenaar H, Bongers BC, van der Sluis G. The challenges of evidence-based prehabilitation in a real-life context for patients preparing for colorectal surgery-a cohort study and multiple case analysis. Perioper Med (Lond). 2025 Jan 17;14(1):7. doi: 10.1186/s13741-024-00481-w.

  PMID: 39825452 DERIVED

Study Officials

• Aletta Danielle Talen, drs

  Nij Smellinghe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mac clinical health scientist

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 3, 2024
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

NL (1)