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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01248-45 | Registry Identifier | ID-RCB |
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Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Its effects are beneficial in the short and medium terms but are limited in time, between 6 and 12 months, for patients who do not pursue regular physical activity (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.
In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.
(PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.
In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.
Exclusion criteria:
Analysis:
Protocol:
This prospective, randomized study with two parallel arms, controlled against standard chronic care will be multicentric and open.
The duration of the inclusions is 18 months and the follow-up will be carried out over 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation | Experimental | Experimental group of 100 patients using the M-Réhab BPCO telerehabilitation solution. The solution will be provided during the fourth and final week of RR's stay during which patients will be trained to use all of the solution's features. Patients will carry out the entire post-rehabilitation using the remote rehabilitation solution and will benefit from medical assessments by teleconsultation at 1, 3, 6 and 12 months as well as assessments at 3, 6 and 12 months by filling. electronic auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home. |
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| Standard chronic care | No Intervention | following usual standard chronic care. Patients will receive during the last week of stay in the center, the usual advice to continue physical activity and nutritional advice at home. The evaluations at 3, 6 and 12 months will be done by electronic filling of auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telerehabilitation | Other | After obtaining consent, the volunteers will be included in the study at the start of the 4th week and randomized into two arms: Experimental and Control group |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program | Quality of life assessed by the Saint Georges Respiratory Questionnaire. Three scores are calculated for the components: Symptoms; Activities; Impacts. A Total SCORE is also calculated. The minimum significant difference is 4 points. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-intentional variables | Perceived risk: questionnaire focused on respiratory disease and conditioned by absence of adoption of physical activity behavior. Expectation of conséquences: questionnaire of the expected effects of Physical activity on physical health and psychological well-being. Self-efficacy: questionnaire relating to their perceived ability to perform the quantity of physical activity recommended by healthcare professionals. Intentions: determination and realization of physical activity behavior in the next months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hopsitalier universitaire de Montpellier | Montpellier | Occitanie | 34295 | France | ||
| Clinique du Souffle |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33511633 | Derived | Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2. |
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This study will be an Open study.
For the primary outcome the analysis will be blind to the investigator
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|
| baseline |
| Post-intentional variables | planning: by a Questionnaire relating to the anticipation of the conditions to realize physical activity. self-efficacy with regard to barriers: questionnaire relating to their perceived ability to perform physical activity recommended despite the difficulties encountered. Social support:questionnaire relating to the behavior of the entourage habits: questionnaire on automatic nature of physical activity behavior. | 6 months |
| Physical Activity behaviors. | Measured by the International Physical Activity Questionnaire as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. walking consider to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. | 12 months |
| Predictive model of physical activity behavior | Test a predictive model of physical activity behavior at 12 months in each of the two arm groups. | At 12 months |
| Osséja |
| 66340 |
| France |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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