Clinical trial NCT03530059: Fast-Track Rehabilitation
Official title: Feasibility at Home of a Rehabilitation Program Before Thoracic Surgery, for Pulmonary Parenchyma Exeresis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Disease
Thoracic Surgery
Lung Cancer
Keywords: Home-based training program
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery
timeFrame: from date of inclusion until the end of hospitalisation for thoracic surgery, assessed up to 6 months
Secondary outcomes:
measure: Post operative event number
timeFrame: 30 days
measure: Rehabilitation program costs
timeFrame: from date of inclusion until the beginning of hospitalisation for thoracic surgery, assessed up to 6 months
measure: Hospitalisation duration
timeFrame: from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
measure: Total hospitalisation cost
timeFrame: from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
Other outcomes:
Locations:
city: Saint-Ismier
country: France
facility: Centre Medivallee
state: ZI La Batie 35 Allée Du Champrond
city: Echirolles
country: France
facility: Maison Medicale Des Cedres
city: Grenoble
country: France
facility: GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD
city: Grenoble
country: France
facility: Chu Grenoble Alpes
city: Saint-Martin-d'Hères
country: France
facility: Cabinet de Chirurgie Cardio Vasculaire
Study officials:
affiliation: CHUGA
name: François ARBIB, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.