NCT04190719

Patient Empowerment for Major Surgery Preparation @ Home

Patient Empowerment for Major Surgery Preparation @ Home: Multimodal Prehabilitation in Major Elective Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program (based on physical activity, nutritional support and mental preparation) for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery

Detailed description

Prehabilitation programs essentially based on physical activity improvement may reduce postoperative complications after major surgery. We hypothesize that a multimodal program based on physical activity, nutritional support and mental preparation may not only improve postoperative recovery and reduce costs but also improve health status beyond postoperative period. Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery. Other outcomes will be measured : length of hospital stay, hospital readmissions, direct costs, health status at 1 and 6 months. Moreover, the feasibility and adherence of Paprika program will be evaluated. Inter-data centres relating to the implementation of the same prehabilitation program will be compared with the consortium Paprika (Hospital Clinic of Barcelona, University of Cologne, University of Gdansk)

Conditions

• Urologic Diseases
• Cardiovascular Diseases
• Thoracic Diseases
• Orthopedic Disorder
• Gastrointestinal Disease

Interventions

Type	Name	Description
OTHER	multimodal prehabilitation	Paprika prehabilitation program content: patients will have choices for each activity. Messages and motivation will be reinforced by using a mobile app or leaflet advices, according to patient's preferences. * Physical activity promotion by discovering ebike, personalised gymnastics and encouragement to increase the number of daily steps of patients, measured by a wristband and a mobile App * An individualized nutritional optimization plan with dietary advices and protein supplementation (if necessary). * Psychological support will be proposed through auto-hypnosis sensibilisation or management of stress with Cognitive Behavior Stress Management technics

Timeline

• Start date: 2020-01-03
• Primary completion: 2021-09-30
• Completion: 2021-12-31
• First posted: 2019-12-09
• Last updated: 2021-04-30

Locations

1 site across 1 country: France