NCT03530059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

1.4 years

First QC Date

February 15, 2018

Last Update Submit

November 14, 2019

Conditions

Respiratory DiseaseThoracic SurgeryLung Cancer

Keywords

Home-based training program

Outcome Measures

Primary Outcomes (1)

  • 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

    from date of inclusion until the end of hospitalisation for thoracic surgery, assessed up to 6 months

Secondary Outcomes (4)

  • 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

  • Hospitalisation duration

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

  • Total hospitalisation cost

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

Interventions

Home-based rehabilitationOTHER

Observational study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Medivallee

Saint-Ismier, ZI La Batie 35 Allée Du Champrond, 38330, France

Location

Maison Medicale Des Cedres

Échirolles, 38130, France

Location

GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD

Grenoble, 38028, France

Location

Chu Grenoble Alpes

Grenoble, 38043, France

Location

Cabinet de Chirurgie Cardio Vasculaire

Saint-Martin-d'Hères, 38400, France

Location

Related Publications (1)

  • 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.

    PMID: 33568371DERIVED

MeSH Terms

Conditions

Respiration DisordersLung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases

Study Officials

  • François ARBIB, MD-PhD

    CHUGA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

May 21, 2018

Study Start

February 9, 2018

Primary Completion

June 21, 2019

Study Completion

July 21, 2019

Last Updated

November 15, 2019

Record last verified: 2019-11

Locations

FR(5)