Respiratory DiseaseFTRNCT03530059
Fast-Track Rehabilitation
An observational study of Respiratory Disease and Thoracic Surgery, run by University Hospital, Grenoble at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Disease, Thoracic Surgery, Lung Cancer
- What is being tested?
- Home-based rehabilitation
- How many people
- 50 participants
- Where
- 5 sitesFrance
- Study dates
- 9 Feb 2018to 21 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * 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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Maison Medicale Des Cedres
Échirolles, 38130
GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD
Grenoble, 38028
Chu Grenoble Alpes
Grenoble, 38043
Centre Medivallee
Saint-Ismier, ZI La Batie 35 Allée Du Champrond, 38330
Cabinet de Chirurgie Cardio Vasculaire
Saint-Martin-d'Hères, 38400
About this study
Official title: Feasibility at Home of a Rehabilitation Program Before Thoracic Surgery, for Pulmonary Parenchyma Exeresis
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.
Read the 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.
- Conditions
- Respiratory Disease, Thoracic Surgery, Lung Cancer
- Being tested
- Home-based rehabilitation
- Keywords
- Home-based training program
- Medical subject headings
- Respiration Disorders, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based rehabilitationOther
Observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery
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
Measured: from date of inclusion until the end of hospitalisation for thoracic surgery, assessed up to 6 months
Secondary outcomes (4)
Post operative event number
Post operative event number
Measured: 30 days
Rehabilitation program costs
Rehabilitation program costs before surgery for the 4 program rehabilitation items
Measured: from date of inclusion until the beginning of hospitalisation for thoracic surgery, assessed up to 6 months
Hospitalisation duration
Hospitalisation duration in days per unit
Measured: from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
Total hospitalisation cost
Total hospitalisation cost per patient = sum for all unit
Measured: from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start9 Feb 2018
- Primary completion21 Jun 2019
- Study completion21 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François ARBIB, MD-PhD, Principal investigator, CHUGA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530059
- Sponsor's protocol ID
- 38RC17.300
- Other IDs
- 2017-A02697-46
- Acronym
- FTR
- Status last verified
- Nov 2019
- First submitted
- 15 Feb 2018
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33568371
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility at Home of a Rehabilitation Program Before Thoracic Surgery, for Pulmonary Parenchyma Exeresis
- ClinicalTrials.gov ID
- NCT03530059
- Acronym / sponsor ID
- FTR / 38RC17.300
- Conditions
- Respiratory Disease, Thoracic Surgery, Lung Cancer
- Keywords
- Home-based training program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jul 2019 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based rehabilitationObservational study | Other | – |
Primary outcome
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
4 secondary outcomes
Post operative event number
Time frame: 30 days
Rehabilitation program costs
Time frame: from date of inclusion until the beginning of hospitalisation for thoracic surgery, assessed up to 6 months
Hospitalisation duration
Time frame: from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
Total hospitalisation cost
Time frame: from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Derived from this study: PubMed 33568371Catho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François ARBIB, MD-PhD principal investigator
CHUGA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease and Thoracic Surgery, run by University Hospital, Grenoble at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03530059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.