Fast-Track Rehabilitation (FTR)

November 14, 2019 updated by: University Hospital, Grenoble

Feasibility at Home of a Rehabilitation Program Before Thoracic Surgery, for Pulmonary Parenchyma Exeresis

This study is a prospective observational study which aim to evaluate the feasibility of a total and systematic home respiratory rehabilitation training program in patients who will undergo thoracic surgery, and otherwise tend to define failure reasons.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this clinical trial is to identify the determining factors which impact a preoperative home respiratory rehabilitation training program success. This success is determined by complete achievement of the program (100%) by the patient.

This rehabilitation program is composed by 4 items:

  • Adapted physical activity : 3 averaging cyclo ergometer or physical activity seances per week (25%)
  • Physiotherapy sessions : 8 seances with a physical therapist (25%)
  • Smokers : Set up of a program to help give up smoking if active smoker (25%)
  • Dietetics : If unintentionally weight loss (>5% total weight in 1 month or >10% in 6 months) or BMI<21 , nutritional assessment is conducted and dietetic program is initiated(25%)

Secondary objectives are :

  • Assessment of postoperative event onset (30 days) (atelectasis, fibro-aspiration, time spent in resuscitation unit, intubation, revision surgery).
  • Link assessment of 100% program success and at least one complication onset.
  • Cost assessment of preoperative rehabilitation program
  • Evaluation of mean hospitalisation duration post surgery (30 days)
  • Average cost assessment of hospitalisation stay per patient.

This study will include 50 patients over 18 years old, addressed to the home heath care provider AGIR à Dom, for rehabilitation before pulmonary parenchyma exeresis.

Patients must perform at least 2 items of rehabilitation program previously described.

This program is an initiative of a pulmonologist or a thoracic surgeon, who include the patient when the date of surgery is scheduled.

Study Type

Observational

Enrollment (Actual)

50

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
      • Echirolles, France, 38130
        • Maison Medicale Des Cedres
      • Grenoble, France, 38043
        • CHU Grenoble Alpes
      • Grenoble, France, 38028
        • GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD
      • Saint-Martin-d'Hères, France, 38400
        • Cabinet de Chirurgie Cardio Vasculaire
    • ZI La Batie 35 Allée Du Champrond
      • Saint-Ismier, ZI La Batie 35 Allée Du Champrond, France, 38330
        • Centre Medivallee

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

Sampling Method

Non-Probability Sample

Study Population

  • All patients over 18 years old referred by a pulmonologist or a thoracic surgeon for a thoracic surgery of pulmonary lobe or lung removal.
  • Be able physically and be enthousiastic to engage a home-training respiratory program.

Description

Inclusion Criteria:

  • Patients who need a respiratory rehabilitation before thoracic surgery for lung resection.
  • Patients addressed to the home heath care provider "AGIR à Dom",
  • Patients must perform at least 2 items of rehabilitation program (Adapted physical activity, Diet, Physiologist, Smoking)

Exclusion Criteria:

  • Patients who participate to another interventional research that may impact this study.
  • Patients unable to get involved to the training program, depending to the investigator's appreciation.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery
Time Frame: from date of inclusion until the end of hospitalisation for thoracic surgery, assessed up to 6 months

Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery :

  • Tobacco: measure of tobacco consumption (self-report)
  • Dietary: body mass
  • Physical activity: number of physical activity sessions
  • Physiotherapy: number of physical therapy sessions
from date of inclusion until the end of hospitalisation for thoracic surgery, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative event number
Time Frame: 30 days
Post operative event number
30 days
Rehabilitation program costs
Time Frame: from date of inclusion until the beginning of hospitalisation for thoracic surgery, assessed up to 6 months
Rehabilitation program costs before surgery for the 4 program rehabilitation items
from date of inclusion until the beginning of hospitalisation for thoracic surgery, assessed up to 6 months
Hospitalisation duration
Time Frame: from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
Hospitalisation duration in days per unit
from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
Total hospitalisation cost
Time Frame: from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
Total hospitalisation cost per patient = sum for all unit
from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: François ARBIB, MD-PhD, CHUGA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 9, 2018

Primary Completion (Actual)

June 21, 2019

Study Completion (Actual)

July 21, 2019

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.300
  • 2017-A02697-46 (Other Identifier: ID RCB)

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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