NCT02878551

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 7, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2017

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

August 22, 2016

Last Update Submit

March 5, 2021

Conditions

SurgeryCancer

Outcome Measures

Primary Outcomes (1)

  • 6 minutes walk test

    7 months

Study Arms (1)

Prehabilitation program

EXPERIMENTAL

Multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being

Other: Prehabilitation program

Interventions

Prehabilitation programOTHER

multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being

Prehabilitation program

Eligibility Criteria

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

You may qualify if:

  • Patients over 18 years old
  • Affiliated with a social security system
  • Having indicated their non-opposition
  • Refusal of participation
  • Pregnant or breastfeeding woman
  • Inability to walk or initial physical assessment
  • Patient under guardianship or curatorship
  • Inability to complete questionnaires

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Morgan Le Guen, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

October 7, 2016

Primary Completion

June 23, 2017

Study Completion

June 23, 2017

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)