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Completed

NCT Number: NCT03530059

Fast-Track Rehabilitation

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.

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Key information

Conditions

Respiratory Disease Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiration Disorders Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-based rehabilitation

Other

Observational study

Primary outcomes

  1. 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

  1. Post operative event number

    Time frame: 30 days

    Post operative event number

  2. Rehabilitation program costs

    Time frame: 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

  3. Hospitalisation duration

    Time frame: from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months

    Hospitalisation duration in days per unit

  4. Total hospitalisation cost

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: FTR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 21, 2018
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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