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Recruiting NCT06579612

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

No phase Interventional Chronic Respiratory Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Personalized follow-up and support.
Who it may be relevant to
Registry conditions: Chronic Respiratory Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Benefits of Individualized Follow-up With a Sport-Health Professional in the Care of Patients With Chronic Respiratory Diseases, to Maintain Long-term Benefits After a Respiratory Rehabilitation Program

Overview

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

Detailed description

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

Each patient is followed up for 24 months with a visit every 6 months. A total of 352 subjects will be recruited

Interventions

  • Other Personalized follow-up and support
    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.

Primary outcome measures

  • Difference in average number of daily steps [Time frame: At inclusion (V1) and at 24 Months (V5)]
Secondary outcome measures (12)
  • Cost-utility comparison between the two groups [Time frame: At 24 Months (V5)]
  • Comparison of changes in physical activity levels between the two groups [Time frame: At 24 Months (V5)]
  • Comparison of changes in physical capacities between the two groups [Time frame: A 24 Months (V5)]
  • Comparison of changes in physical capacities between the two groups [Time frame: A 24 Months (V5)]
  • Comparison of changes in physical capacities between the two groups [Time frame: A 24 Months (V5)]
  • Comparison of changes in symptoms between the two groups [Time frame: At 24 Months (V5)]
  • Comparison of changes in psychological dimensions between the two groups [Time frame: At 24 Months (V5)]
  • Comparison of changes in psychological dimensions between the two groups [Time frame: At 24 Months (V5)]
  • Comparison of changes in health indicator between the two groups [Time frame: At 24 Months (V5)]
  • Comparison of changes in quality of life indicator between the two groups [Time frame: At 24 Months (V5)]
  • Comparison of changes in parameters (barriers and levers to physical activity) between the two groups [Time frame: At 24 Months (V5)]
  • Comparison of changes in physical capacities between the two groups [Time frame: At 24 Months (V5)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Any medical contraindication to the practice of adapted physical activity in rehabilitation
  • Patients under guardianship or curatorship
  • Patients deprived of their liberty
  • Patients over 80 years of age at the time of inclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 2 centers
  • CHU de Brest — Brest
  • CH des Pays de Morlaix — Morlaix

Identifiers

NCT: NCT06579612 · 29BRC22.0256

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗