- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03530059
Fast-Track Rehabilitation (FTR)
Feasibility at Home of a Rehabilitation Program Before Thoracic Surgery, for Pulmonary Parenchyma Exeresis
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Echirolles, Frankrike, 38130
- Maison Medicale Des Cedres
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Grenoble, Frankrike, 38043
- Chu Grenoble Alpes
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Grenoble, Frankrike, 38028
- GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD
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Saint-Martin-d'Hères, Frankrike, 38400
- Cabinet de Chirurgie Cardio Vasculaire
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ZI La Batie 35 Allée Du Champrond
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Saint-Ismier, ZI La Batie 35 Allée Du Champrond, Frankrike, 38330
- Centre Medivallee
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
- 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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery
Tidsram: 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 :
|
from date of inclusion until the end of hospitalisation for thoracic surgery, assessed up to 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Post operative event number
Tidsram: 30 days
|
Post operative event number
|
30 days
|
Rehabilitation program costs
Tidsram: 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
|
from date of inclusion until the beginning of hospitalisation for thoracic surgery, assessed up to 6 months
|
Hospitalisation duration
Tidsram: from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
|
Hospitalisation duration in days per unit
|
from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
|
Total hospitalisation cost
Tidsram: 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
|
from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: François ARBIB, MD-PhD, CHUGA
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 38RC17.300
- 2017-A02697-46 (Annan identifierare: ID RCB)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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