Chronic Respiratory Disease
Conditions
Keywords
chronic respiratory disease, pulmonary rehabilitation
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
Interventions
OTHERPersonalized 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.
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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,
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 motivation scores according to different levels of regulation assessed by the Motivation for Physical Activity for Health Purposes Scale (EMAPS). This questionnaire includes 18 items. The EMAPS is used to evaluate the motivation to practice physical activities. The answer to questions goes from 1 to 7 with 1 (does not match at all) and 7 (matches very strongly). |
| 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). |
Countries
France
Contacts
CONTACTMarie-Agnès GIROUX-METGES, MD, PhD
CONTACTBaptiste Chéhère, PhD
PRINCIPAL_INVESTIGATORMarie-Agnès GIROUX-METGES, MD, PhD
Brest Universty Hospital
Outcome results
None listed