The Benefits of Individualized Follow-up With a Sport-Health Professional in the Care of Patients With Chronic Respiratory Diseases

NCT06579612 | Recruiting

• 1 other identifier: 29BRC22.0256
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 2

Brief Summary

Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term. The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits. This study concerns patients with a diagnosis of one or more chronic respiratory diseases. It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms:

• a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group)
• a control group receiving only usual care

Conditions

Chronic Respiratory Disease

Keywords

chronic respiratory disease; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• Difference in average number of daily steps

  The difference in average daily steps measured by accelerometry (over 7 days) at the end of the pulmonary rehabilitation course (V1) and after 24 months of personalized follow-up (V5).

  At inclusion (V1) and at 24 Months (V5)

Secondary Outcomes (13)

• Cost-utility comparison between the two groups

  At 24 Months (V5)

• Comparison of changes in physical activity levels between the two groups

  At 24 Months (V5)

• Comparison of changes in physical capacities between the two groups

  A 24 Months (V5)

• Comparison of changes in physical capacities between the two groups

  A 24 Months (V5)

• Comparison of changes in physical capacities between the two groups

  A 24 Months (V5)

Study Arms (2)

Control arm

NO INTERVENTION

Patient in the control arm will beneficiate from commun practice

Experimental arm

EXPERIMENTAL

Patient in the control arm will beneficiate from a personalized follow-up and support after a pulmonary rehabilitation program

Other: Personalized follow-up and support

Interventions

Personalized follow-up and support OTHER

After a pulmonary rehabilitation program, an interview with a professional will enable the professional to identify the barriersand enablers of physical activity engagement, and to identify (with the patient) a plan for maintaining a physical activities adapted in daily life. Adapted solutions will then be proposed.

Experimental arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of one or more chronic respiratory diseases (asthma, chronic obstructive pulmonary disease, diffuse interstitial lung disease, bronchiectasis, obstructive sleep apnea syndrome, etc.).
• Participation in a respiratory pulmonary program
• Have given consent
• Patient of legal age
• Patient affiliated to Social Security

You may not qualify if:

• Any medical contraindication to the practice of adapted physical activity in rehabilitation
• Patients under guardianship or curatorship
• Patients deprived of their liberty

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHU de Brest

Brest, 29609, France

RECRUITING

CH des Pays de Morlaix

Morlaix, 29672, France

RECRUITING

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marie-Agnès GIROUX-METGES, MD, PhD

  Brest Universty Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Agnès GIROUX-METGES, MD, PhD

CONTACT

+33298347366; marie-agnes.metges@chu-brest.fr

Baptiste Chéhère, PhD

CONTACT

baptiste.chehere@univ-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled superiority trial in parallel arms (1:1 ratio) comparing personalized follow-up and support after a pulmonary rehabilitation program (experimental group) versus a control group receiving only usual care,

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 30, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): November 7, 2029
• Study Completion (Estimated): November 7, 2029
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (2)