The Benefits of Individualized Follow-up with a Sport-Health Professional in the Care of Patients with Chronic Respiratory Diseases
- Conditions
- Chronic Respiratory Disease
- Interventions
- Other: Personalized follow-up and support
- Registration Number
- NCT06579612
- Lead Sponsor
- University Hospital, Brest
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 352
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental arm Personalized follow-up and support Patient in the control arm will beneficiate from a personalized follow-up and support after a pulmonary rehabilitation program
- Primary Outcome Measures
Name Time Method Difference in average number of daily steps 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 Outcome Measures
Name Time Method Cost-utility comparison between the two groups At 24 Months (V5) 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.
Comparison of changes in physical activity levels between the two groups At 24 Months (V5) 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)Comparison of changes in physical capacities between the two groups A 24 Months (V5) The evolution of physical capacities is assessed with the quadriceps strength measured in the maximal isometric contraction test.
Comparison of changes in symptoms between the two groups At 24 Months (V5) The evolution of symptoms is assessed with dyspnoea score (DYSPNEA-12). The DYSPNEA-12 comprised of 12 different breathlessness descriptors with each scored on a four-item scale (none-0, mild-1, moderate2, severe-3). Item scores are summed (D-12 Total) and can be divided into sub-scores reflecting Physical and Affective domains.
Comparison of changes in psychological dimensions between the two groups At 24 Months (V5) The evolution of psychological dimensions is assessed with the anxiety and depression scores using the Hospital Anxiety and Depression scale (HAD). This questionnaire includes 7 items for depression and 7 items for anxiety. Each item had been answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and for depression. A score of 0 to 7 for either subscale could be regarded as being in the normal range, a score of 11 or higher indicating probable presence ('caseness') of the mood disorder and a score of 8 to 10 being just suggestive of the presence of the respective state.
Comparison of changes in health indicator between the two groups At 24 Months (V5) The evolution of health indicator is assessed with a St George's Respiratory Questionnaire (SGRQ). This questionnaire comprises 3 components: the symptom component assesses the effects of respiratory symptoms, their frequency and severity, the activity component looks at activities that cause and/or are limited by breathlessness, and the impact component assesses the disruption to social and psychological functioning induced by the disease. The total score ranges from 100 (low quality of life) to 0 (excellent quality of life).
Comparison of changes in quality of life indicator between the two groups At 24 Months (V5) The evolution of quality of life indicator is assessed with EuroQol " five dimensions questionnaire " (EQ5DL). EQ5DL is a questionnaire including 5 items mobility, personal care, usual activities, pain/discomfort and anxiety/depression.
Comparison of changes in parameters (barriers and levers to physical activity) between the two groups At 24 Months (V5) The evolution of parameters (barriers and levers to physical activity) is assessed with the socioeconomic investigation results. This questionnaire was created for this study to gather information on the socio-economic and environmental profile of people in relation to the practice of physical activity (Barriers and levers to practice, transportation, cost of practicing physical activity, place of practice).
Trial Locations
- Locations (2)
CHU de Brest
🇫🇷Brest, France
CH des Pays de Morlaix
🇫🇷Morlaix, France