- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02878551
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
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
-
-
-
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
|
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
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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