Fast-Track Rehabilitation

NCT ID: NCT03530059

Last Updated: 2019-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-09

Study Completion Date

2019-07-21

Brief Summary

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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

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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.

Conditions

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Respiratory Disease Thoracic Surgery Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Home-based rehabilitation

Observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François ARBIB, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHUGA

Locations

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Centre Medivallee

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

Site Status

Maison Medicale Des Cedres

Échirolles, , France

Site Status

GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD

Grenoble, , France

Site Status

Chu Grenoble Alpes

Grenoble, , France

Site Status

Cabinet de Chirurgie Cardio Vasculaire

Saint-Martin-d'Hères, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33568371 (View on PubMed)

Other Identifiers

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2017-A02697-46

Identifier Type: OTHER

Identifier Source: secondary_id

38RC17.300

Identifier Type: -

Identifier Source: org_study_id

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