Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-02 @ 5:29 AM
Study NCT ID:
NCT03530059
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2018-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast-Track Rehabilitation
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Feasibility at Home of a Rehabilitation Program Before Thoracic Surgery, for Pulmonary Parenchyma Exeresis
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FTR
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-A02697-46 | OTHER | ID RCB | View |