Digital Home-Based Prehabilitation Before Surgery

NCT06231576 | Not Yet Recruiting

• 1 other identifier: 23/08551
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. The prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.

Conditions

Cancer Colorectal; Frailty; Surgery

Keywords

Prehabilitation; Colorectal cancer; Frailty

Outcome Measures

Primary Outcomes (1)

• 6MWT

  Distance (in meters) walked in 6 minutes

  At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

Secondary Outcomes (8)

• EuroQol Group Questionnaire 5D (EQ-5D)

  At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

• European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire

  At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

• Generic Short Patient Experiences Questionnaire (GS-PEQ)

  At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

• Mortality

  3 months after surgery

• Complications

  3 months after surgery

Other Outcomes (3)

• DNA methylation

  At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

• RNA methylation

  At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

• Metabolome

  At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

Study Arms (3)

Hospital

EXPERIMENTAL

Prehabilitation at the hospital, with guidance by a dedicated physiotherapist physically present.

Other: Prehabilitation

Digital

EXPERIMENTAL

Prehabilitation at home, with guidance from a dedicated physiotherapist through a digital platform, realtime.

Other: Prehabilitation

Control

NO INTERVENTION

Information about the general benefit of a healthy lifestyle at inclusion, thereafter no further follow-up prior to surgery.

Interventions

Prehabilitation OTHER

* Nutritional optimization: A nutritionist will perform a structured interview, comprehensive nutrition assessment, and provide personalized dietary advice. The main goal is to ensure optimal protein intake to support exercise-induced anabolism. A daily protein intake of 1.2-2.0 g/kg will meet needs as outlined in surgical nutrition guidelines. * Exercise: Based on current guidelines and instructed by a dedicated physiotherapist, for 1 hour per day preoperatively to increase muscle strength, aerobic capacity and physical endurance. Intensity will be based on the rate of perceived exertion using the Borg scale, a 15-graded scale ranging from very light to very hard. Resistance exercises will target upper/lower body, and abdominal muscles. * Psychological coaching and support: Performed as one interview during inclusion, followed by weekly phone calls by a study nurse coordinator during the preoperative intervention.

Digital; Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for major gastrointestinal cancer surgery
• Fluent in Norwegian and able to consent and to understand questionnaires

You may not qualify if:

• Inability to walk for six minutes or to rise independently from a chair
• Inability to comprehend exercise program or to comply with written and oral instructions
• Presence of a cardio-pulmonary condition that precludes exercise
• Living in very remote areas making a hospital-based intervention group impossible to implement
• Being without a permanent address
• Admittance to a hospital facility for \> 50% of the time from diagnosis to surgery

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Diakonhjemmet Hospital: collaborator

Related Publications (1)

• Kleve G, Santa CD, Kristiansen F, Tegnander M, Buch V, Hagemann CS, Helgheim M, Engene P, Pesonen H, Kleveland MK, Hverven GL, Nilsen TS, Vervaart MAM, Aanesen H, Uglane KT, Bjelland M, Zory R, Chorin F, Cardot-Ruffino V, Beltran EEM, Neuzillet C, Soerensen M, Jylhava J, Anzar I, Normand VA, Myrstad M, Klungland A, Nilsen HL, Ougland R. Digital home-based multimodal prehabilitation of colorectal cancer patients prior to surgery (the dHOPE study): a non-inferiority clinical trial protocol. Front Digit Health. 2025 Oct 8;7:1609678. doi: 10.3389/fdgth.2025.1609678. eCollection 2025.

  PMID: 41132395 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Frailty; Colorectal Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rectal Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rune Ougland, MD PhD

  Vestre Viken, Bærum Hospital, Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guro Kleve, MD

CONTACT

+47 32 80 30 00; guro.kleve@vestreviken.no

Rune Ougland, MD PhD

CONTACT

+47 32 80 30 00; rune.ougland@vestreviken.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: January 30, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: By end of 2024
• Access Criteria: Upon request