Rehabilitation by Effort for Patients With Advanced Bronchial Cancer (RehabKBP)

September 18, 2023 updated by: University Hospital, Toulouse

Bronchopulmonary cancers or mesothelioma are associated with effort deconditioning due to pathology (chronic inflammation) and also to treatments (surgery, radiotherapy, chemotherapy); it's considerably alters patients quality of life.

Investigators want to ensured the feasibility of rehabilitation by effort for these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31059
        • CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • General condition according to World Health Organisation 0-1
  • Age between 18 and 70 years old
  • Non progressive patients according to RECIST criteria 1.1 after chemotherapy treatment whichever line of treatment
  • Autonomous patient
  • Voluntary written informed consent signed
  • Patients with social security insurance

Exclusion Criteria:

  • Bone metastasis with fracture risk
  • Significant cardiovascular pathology
  • Cardiac, vascular, rheumatologic or neurologic contraindication
  • Patients living far 60 kms from Toulouse
  • Patients under juridical protection guardianship, or tutelage measure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rehabilitation by effort
8 sessions of rehabilitation by effort in sports medicine
Behavioral: rehabilitation by effort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients who completed at least 6 sessions of rehabilitation
Time Frame: 10 years
number of patients who completed at least 6 sessions of rehabilitation by effort
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Julien Mazières, MD PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

July 24, 2019

Study Completion (Actual)

July 24, 2019

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/11/0087

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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