Long Term Effects and of a Pulmonary Rehabilitation Maint... | NCT03704935

Studies
Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program

NCT03704935

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Mar 10, 2020Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Chronic Respiratory Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2018Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

Dec 30, 2019Actual

First Submitted Date

Oct 10, 2018

First Submission Date that Met QC Criteria

Oct 10, 2018

First Posted Date

Oct 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2020

Last Update Posted Date

Mar 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Chronic respiratory diseases are characterized by a progressive and long term deline. Pulmonary rehabilitation (exercise training and therapeutic education) can improve several disease outcomes like dyspnea, exercise tolerance and health-related quality of life. After an inpatient PR program, maintenance program can stabilize the disease outcomes. However, maintenance program are heterogeneous and long term benefits (>36 month) have been observed in only one study, which is not feasible in France. A realistic maintenance program as proposed by the French Air+R network (http://airplusr.com/wordpress/) has only demonstrated benefits after 12 month. In addition, the time course of patients may be heterogeneous, with differens clusters that could be influenced by the clinical, functional and systemic determinants. In particular, the cellular muscle microenvironment could be deleterious for the muscle function in patients, caused by a "spill-over" of inflammatory pulmonary molecules in the systemic milieu.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
6 minutes walking distance	6 minutes walking distance	10 years

Secondary Outcomes

Measure	Description	Time Frame
health-related quality of life	health-related quality of life : VQ-11 questionnaire	10 years
Forced expiratory volume in 1 seconde	Forced expiratory volume in 1 seconde : FEV1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients with a chronic respiratory disease (COPD, Asthma, bronchiectasis , Fibrosis, Sleep Apnea, …) undergoing pulmonary rehabilitation (maintenance or inpatient)

Exclusion criteria:

Contraindication to exercise training

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with a chronic respiratory disease (COPD, Asthma, bronchiectasis , Fibrosis, Sleep Apnea, …) undergoing pulmonary rehabilitation (maintenance or inpatient)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Farés Gouzi, MD, PhD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of clinical Physiology - University Hospital		Montpellier		34295	France