NCT04190719

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

January 3, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 30, 2021

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

December 3, 2019

Last Update Submit

April 29, 2021

Conditions

Urologic DiseasesCardiovascular DiseasesThoracic DiseasesOrthopedic DisorderGastrointestinal Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    at Day-30 post surgery

Secondary Outcomes (10)

  • Number and severity of postoperative complications

    within 30 days post surgery

  • Length of stay (ICU and Hospital)

    within 30 days post surgery

  • Hospital readmission

    within 30 days post surgery

  • Direct cost

    interventional group: 1 month-cost before surgery+1 month-post surgery / Control group: 1 month-cost post-surgery

  • Physical activity health status

    a baseline, presurgery and 6 months post surgery

  • +5 more secondary outcomes

Study Arms (2)

Paprika group

EXPERIMENTAL

Patients coming for elective major surgery will participate to Paprika program

Other: multimodal prehabilitation

Historical group

NO INTERVENTION

Patients previously operated with same characteristics

Interventions

multimodal prehabilitationOTHER

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

Paprika group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient eligible to elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)
  • Age \> 70 years and/or American Society of Anesthesiologists (ASA) score 3-4
  • or Unfit patient according to appropriate scores (Two among 3 scores (HAD, Physical activity score, nutritional score) below threshold). Unfit patients will be defined by at least 2 criteria if 'YES' answers: Physical activity: Less than 50% of WHO recommendations = less than 5000 steps/day or less than 75 min moderate activity/week or less than 12 min moderate activity/day Yes/No Malnutrition: BMI \< 20 kg/m2 if \< 70 years (or \<22 if \>70y) = undernutrition Yes/No or BMI\>25 kg/m2 (= overweight to obesity) or Loss of appetite? Mental evaluation HAD (Hospital Anxiety and Depression) \>8 for A or D score Yes/No
  • Diagnosis:
  • Elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)
  • \- Regulatory aspects: Be legally able to give consent Patient affiliated to social security

You may not qualify if:

  • Urgent surgery
  • Patient with, at baseline, good to excellent physical, nutritional, mental status as defined by appropriate scores.
  • Patient considered not eligible to this program for physical or psychological reasons by the surgeon or the anesthetist
  • Persons referred in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, 38700, France

RECRUITING

Related Publications (2)

  • Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

    PMID: 28489682RESULT

  • Barberan-Garcia A, Ubre M, Pascual-Argente N, Risco R, Faner J, Balust J, Lacy AM, Puig-Junoy J, Roca J, Martinez-Palli G. Post-discharge impact and cost-consequence analysis of prehabilitation in high-risk patients undergoing major abdominal surgery: secondary results from a randomised controlled trial. Br J Anaesth. 2019 Oct;123(4):450-456. doi: 10.1016/j.bja.2019.05.032. Epub 2019 Jun 25.

    PMID: 31248644RESULT

MeSH Terms

Conditions

Urologic DiseasesCardiovascular DiseasesThoracic DiseasesMusculoskeletal DiseasesGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRespiratory Tract DiseasesDigestive System Diseases

Study Officials

  • Pierre Albaladejo, Prof.

    CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-France Vaillant

CONTACT

+33 4 76 76 89 13mfvaillant@chu-grenoble.fr

Laura Albaladejo

CONTACT

EXT-LAlbaladejo@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Paprika program will be proposed to all eligible patients.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Interventional group: Patients with Paprika program Historical group: Patients with same characteristics operated in 2018-2019
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 9, 2019

Study Start

January 3, 2020

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

April 30, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Anonymised data will be shared with Barcelona, Köln and Gdansk: all collected IPD

Shared Documents
CSR
Time Frame
Data will be available at the end of the study: starting July 2021
Access Criteria
IPD will be shared with other sites in order to compare results coming from common questionnaires and data. Statistical analyses will be performed for Grenoble site separately and pooled with the other sites in a second step.

Locations

FR(1)