Fast-Track Rehabilitation

Completed

• Conditions: Respiratory Disease; Lung Cancer; Thoracic Surgery

• Registration Number: NCT03530059
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

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 Timeline

• Study Start: 2018-02-09
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-21
• Primary Completion: 2019-06-21
• Study Completion: 2019-07-21
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Post operative event number	30 days	Post operative event number
Rehabilitation program costs	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
Hospitalisation duration	from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months	Hospitalisation duration in days per unit
Total hospitalisation cost	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

Trial Locations

Locations (5)

Centre Medivallee; 🇫🇷 Saint-Ismier, ZI La Batie 35 Allée Du Champrond, France

Cabinet de Chirurgie Cardio Vasculaire; 🇫🇷 Saint-Martin-d'Hères, France

GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD; 🇫🇷 Grenoble, France

Maison Medicale Des Cedres; 🇫🇷 Echirolles, France

Chu Grenoble Alpes; 🇫🇷 Grenoble, France