Evaluation of the Benefits of a Prehabilitation Program : Pilot Study (PrehabPilote)

March 5, 2021 updated by: Hopital Foch

Evaluation of the Benefits of a Program of Prehabilitation: Pilot Study

The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". In the present pilot trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 18 years old
  • Affiliated with a social security system
  • Having indicated their non-opposition
  • Must undergo a surgical intervention within a period of at least one month after the completion of the initial inclusion assessment and / or chemotherapy and / or radiotherapy

Non-inclusion criteria:

  • Refusal of participation
  • Pregnant or breastfeeding woman
  • Inability to walk or initial physical assessment
  • Patient under guardianship or curatorship
  • Inability to complete questionnaires

Exclusion criteria:

  • Cognitive disorders detected by the geriatric consultation
  • Lost
  • Death before surgery or chemotherapy or radiotherapy
  • Shortened preoperative preparation time (<18 days)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation program
Multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being
Other: Prehabilitation program
multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 minutes walk test
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2016

Primary Completion (Actual)

June 23, 2017

Study Completion (Actual)

June 23, 2017

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2016/29
  • 2016-A00981-50 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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