Clinical trial NCT06579612: The Benefits of Individualized Follow-up with a Sport-Health Professional in the Care of Patients with Chronic Respiratory Diseases
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Respiratory Disease
Keywords: chronic respiratory disease
pulmonary rehabilitation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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,
Primary purpose: SUPPORTIVE_CARE

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

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

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
* Patient refusal
* Patients under guardianship or curatorship
* Patients deprived of their liberty
* Minors
* Patients over 80 years of age at the time of inclusion.

Primary outcomes:
measure: Difference in average number of daily steps
timeFrame: At inclusion (V1) and at 24 Months (V5)
Secondary outcomes:
measure: Cost-utility comparison between the two groups
timeFrame: At 24 Months (V5)
measure: Comparison of changes in physical activity levels between the two groups
timeFrame: At 24 Months (V5)
measure: Comparison of changes in physical capacities between the two groups
timeFrame: A 24 Months (V5)
measure: Comparison of changes in physical capacities between the two groups
timeFrame: A 24 Months (V5)
measure: Comparison of changes in physical capacities between the two groups
timeFrame: A 24 Months (V5)
measure: Comparison of changes in symptoms between the two groups
timeFrame: At 24 Months (V5)
measure: Comparison of changes in psychological dimensions between the two groups
timeFrame: At 24 Months (V5)
measure: Comparison of changes in psychological dimensions between the two groups
timeFrame: At 24 Months (V5)
measure: Comparison of changes in health indicator between the two groups
timeFrame: At 24 Months (V5)
measure: Comparison of changes in quality of life indicator between the two groups
timeFrame: At 24 Months (V5)
measure: Comparison of changes in parameters (barriers and levers to physical activity) between the two groups
timeFrame: At 24 Months (V5)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
city: Morlaix
country: France
facility: CH des Pays de Morlaix
Study officials:
affiliation: Brest Universty Hospital
name: Marie-Agnès GIROUX-METGES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: