An interventional study of multimodal prehabilitation in Urologic Diseases, Cardiovascular Diseases and Thoracic Diseases, sponsored by University Hospital, Grenoble. Status unknown at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Prevention
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
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)
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's planned enrollment of 225 is above the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →University Hospital, Grenoble is the lead sponsor of 816 studies on the registry; 206 are open to participants now.
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Elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)
Exclusion Criteria:
Patients coming for elective major surgery will participate to Paprika program
Other: multimodal prehabilitation
Patients previously operated with same characteristics
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
Rate of postoperative complications at Day-30
Rate of postoperative complications at Day-30 classified following the standards of the European Society of Anaesthesiology and European Society of intensive Care Medicine.
Time frame: at Day-30 post surgery
Number and severity of postoperative complications
Number and severity of postoperative complications using Dindo-Clavien classification within 30 days
Time frame: within 30 days post surgery
Length of stay (ICU and Hospital)
Length of ICU stay and Length of hospital stay
Time frame: within 30 days post surgery
Hospital readmission
Hospital readmission within 30 days
Time frame: within 30 days post surgery
Direct cost
Valuation in euros of the direct cost from a 1-month hospital point of view (duration and type of stay, acts, GHM...) by integrating for the intervention group the cost of the pre-habilitation program. Care consumption at 6 months from a social security perspective (Probabilistic Matching National Health Data System)--\> comparison of direct costs for the Prehab sessions (professional caregivers and materials costs) versus complication costs of control group
Time frame: interventional group: 1 month-cost before surgery+1 month-post surgery / Control group: 1 month-cost post-surgery
Physical activity health status
Health status based on physical activity score:GPAQ and DASI scores
Time frame: a baseline, presurgery and 6 months post surgery
Nutritional health status
Nutritional health status based on weight, appetite and ingesta measurements
Time frame: at baseline, 1 month and 6 months
Psychological health status
Psychological health status based on HAD, Perceived Stress Scale scores
Time frame: at baseline, 1 month and 6 months
Number of patient participation to program in relation to the number of eligible patients
Number of patient participation to program in relation to the number of eligible patients to assess faisability
Time frame: During Paprika inclusion period
Ratio patient participation to each session
Ratio patient participation to each session to assess faisability and limitation to participation
Time frame: During Paprika 1 month-sessions
Comparison with other centers
Comparison will be done with other cohorts using Paprika program (Barcelona, Gdansk and Köln) on common outcomes
Time frame: through study completion, an average of 1 year
Plan to share: Yes — Anonymised data will be shared with Barcelona, Köln and Gdansk: all collected IPD
Supporting information: Csr
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble