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Clinical Trials/NCT03530059
NCT03530059
Completed
N/A

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

University Hospital, Grenoble5 sites in 1 country50 target enrollmentFebruary 9, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Disease
Sponsor
University Hospital, Grenoble
Enrollment
50
Locations
5
Primary Endpoint
Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 9, 2018
End Date
July 21, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Hospitalisation duration(from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months)
  • Post operative event number(30 days)
  • Rehabilitation program costs(from date of inclusion until the beginning of hospitalisation for thoracic surgery, assessed up to 6 months)
  • Total hospitalisation cost(from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months)

Study Sites (5)

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