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Clinical Trials/NCT06579612
NCT06579612
Recruiting
Not Applicable

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

University Hospital, Brest2 sites in 1 country352 target enrollmentNovember 7, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
University Hospital, Brest
Enrollment
352
Locations
2
Primary Endpoint
Difference in average number of daily steps
Status
Recruiting
Last Updated
8 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 7, 2024
End Date
November 7, 2029
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Difference in average number of daily steps

Time Frame: At inclusion (V1) and at 24 Months (V5)

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).

Secondary Outcomes

  • Cost-utility comparison between the two groups(At 24 Months (V5))
  • Comparison of changes in physical capacities 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 symptoms between the two groups(At 24 Months (V5))
  • Comparison of changes in quality of life indicator between the two groups(At 24 Months (V5))
  • Comparison of changes in parameters (barriers and levers to physical activity) between the two groups(At 24 Months (V5))
  • Comparison of changes in psychological dimensions between the two groups(At 24 Months (V5))
  • Comparison of changes in health indicator between the two groups(At 24 Months (V5))

Study Sites (2)

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