Digital Home-Based Prehabilitation Before Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVestre Viken Hospital Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Planned for major gastrointestinal cancer surgery
Fluent in Norwegian and able to consent and to understand questionnaires
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Prehabilitation
Other intervention* 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.
Treatment groups
140 Participants
are divided into 3 treatment groupsGroup A: HospitalExperimental treatment 1 intervention
Group B: DigitalExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
6MWT
Distance (in meters) walked in 6 minutes
Time frame
At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgerySecondary outcomes
1
EuroQol Group Questionnaire 5D (EQ-5D)
EQ-5D is a standardized measure of health-related quality of life with 5 dimensions, each dimension represented by a value 1-5 where higher value represents worse outcome.
Time frame
At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery2
European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Time frame
At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery3
Generic Short Patient Experiences Questionnaire (GS-PEQ)
GS-PEQ is a questionnaire for collecting data about user experiences across different types of services. The questionnaire has 12 questions ranging from 1-5; a higher score represents a higher ("better") experience.
Time frame
At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery4
Mortality
90-day mortality
Time frame
3 months after surgeryOther outcomes
1
DNA methylation
Blood samples for DNA methylation profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation.
Time frame
At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery2
RNA methylation
Blood samples for RNA methylation profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation.
Time frame
At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery3
Metabolome
Blood samples for metabolome profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation.
Time frame
At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vestre Viken Hospital Trust
Lead sponsor
Diakonhjemmet Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: