Fast-Track Rehabilitation (FTR)

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: Lung Cancer; Thoracic Surgery; Respiratory Disease
• Intervention / Treatment: Other: Home-based rehabilitation

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

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

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

How is the study designed?

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	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	Post operative event number	30 days
Rehabilitation program costs	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	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	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

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: François ARBIB, MD-PhD, CHUGA

Publications and helpful links

General Publications

• Catho H, Guigard S, Toffart AC, Frey G, Chollier T, Brichon PY, Roux JF, Sakhri L, Bertrand D, Aguirre C, Gorain S, Wuyam B, Arbib F, Borel JC. What are the barriers to the completion of a home-based rehabilitation programme for patients awaiting surgery for lung cancer: a prospective observational study. BMJ Open. 2021 Feb 10;11(2):e041907. doi: 10.1136/bmjopen-2020-041907.

Study record dates

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: Home-based training program
• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• 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