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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Brest

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personalized follow-up and support

    Other intervention

    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.

Treatment groups

352 Participants
are divided into 2 treatment groups
Group A: Control armNo intervention 0 interventions
Group B: Experimental armExperimental treatment 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

Cost-utility comparison between the two groups

The cost-utility comparison between the two groups at 24 months was carried out by means of a medico-economic evaluation. This evaluation contains 5 items : direct medical costs; costs of care in the experimental group; incremental cost-utility ratio at 24 months; medical indicator results measured in QALYs and health-related quality of life.

Time frame
At 24 Months (V5)
2

Comparison of changes in physical activity levels between the two groups

the evolution of physical activity levels is assessed with levels of activity : * Sedentary time (min/day) * Time spent in activity with light intensity (min/day) * Time spent in activity with moderate intensity (min/day) * Time spent in activity with vigorous intensity (min/day)

Time frame
At 24 Months (V5)
3

Comparison of changes in physical capacities between the two groups

The evolution of physical capacities is assessed with walking distance measured in the 6-minute walk test. The 6-minute walk test: total walked distance (in metres). The test will be performed twice, the best performance will be kept as reference value.

Time frame
A 24 Months (V5)
4

Comparison of changes in physical capacities between the two groups

The evolution of physical capacities is assessed with the endurance time on ergocycle at 80% of peak power, in seconds.

Time frame
A 24 Months (V5)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.