Study Stopped
As the possible regulatory deadline for the research was exceeded, due to logistical difficulties in setting up the study, and in agreement with the sponsor and the principal investigator, it was decided not to extend the study.
Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months
PREHAB-COURT
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This study aimed to evaluated the interest of a short-term (2 weeks) prehabilitation program compared to no prehabilitation before thoracic or urological surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2019
Typical duration for not_applicable
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
Study Start
First participant enrolled
December 20, 2019
CompletedFirst Submitted
Initial submission to the registry
February 14, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2022
CompletedAugust 4, 2022
August 1, 2022
2.2 years
February 14, 2020
August 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (6 minutes walk test)
Change on the 6-minute walk test (distance covered over a time of 6 minutes in meters)
7 months
Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (Borg scale)
Change in the Borg scale (exertion from 0 to 10: 0 meaning no exertion, 10 meaning maximal exertion)
7 months
Secondary Outcomes (44)
Evaluated the change in cardio-respiratory capacity (VO2 max) of patient following a short prehabilitation at 15 days compared to the initial assessment
15 days
Evaluated the change in cardio-respiratory capacity (spirometry: maximal voluntary ventilation) of patient following a short prehabilitation at 15 days compared to the initial assessment
15 days
Evaluated the change in cardio-respiratory capacity (spirometry: vital capacity) of patient following a short prehabilitation at 15 days compared to the initial assessment
15 days
Evaluated the change in cardio-respiratory capacity (spirometry: functional residual capacity) of patient following a short prehabilitation at 15 days compared to the initial assessment
15 days
Evaluated the change in cardio-respiratory capacity (heart rate) of patient following a short prehabilitation at 15 days compared to the initial assessment
15 days
- +39 more secondary outcomes
Study Arms (2)
Short prehabilitation
EXPERIMENTALThis arm will benefit from a 2 weeks prehabilitation program including a personalized dietetic and physical training program as well as psychological support.
No prehabilitation
OTHERThis arm will not benefit from a prehabilitation program before surgery. Patients will be told to maintain a regular physical activity without support.
Interventions
* Initial assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) and a geriatrician (for patients over 75 years old) * Patient will be asked to follow a 2 weeks prehabilitation program * 2 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) * 6 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)
* Standard care: Initial assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) and a geriatrician (for patients over 75 years old) * Patients will be asked to maintain regular physical activity without support * 2 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) * 6 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)
Eligibility Criteria
You may qualify if:
- Men or women aged 55 or over
- Having signed a consent form after a reflection period
- Being affiliated to a Health Insurance plan.
You may not qualify if:
- Pregnant, parturient or lactating women
- Persons deprived of their liberty: minors or adults subject to legal protection measures or out of state to express their consent
- Patients (men or women) aged \<55 years;
- Inability to walk or initial physical assessment
- Inability to complete questionnaires
- Walk\> 450 meters in the 6 minute test
- Patients under guardianship or curators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Morgan Le Guen, MD
Hopital Foch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2020
First Posted
April 17, 2020
Study Start
December 20, 2019
Primary Completion
March 11, 2022
Study Completion
March 11, 2022
Last Updated
August 4, 2022
Record last verified: 2022-08