Fast-Track Rehabilitation

Lung Cancer Clinical Trial

— FTR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530059
• Other study ID #: 38RC17.300
• Secondary ID: 2017-A02697-46
• Status: Completed
• Start date: February 9, 2018
• Est. completion date: July 21, 2019

Study information

• Verified date: November 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Thoracic Surgery

Intervention

Other:
• Home-based rehabilitation
Observational study

Locations

Country	Name	City	State
France	Maison Medicale Des Cedres	Echirolles
France	Chu Grenoble Alpes	Grenoble
France	GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD	Grenoble
France	Centre Medivallee	Saint-Ismier	ZI La Batie 35 Allée Du Champrond
France	Cabinet de Chirurgie Cardio Vasculaire	Saint-Martin-d'Hères

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post operative event number	Post operative event number	30 days
Secondary	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
Secondary	Hospitalisation duration	Hospitalisation duration in days per unit	from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
Secondary	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