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In a rehabilitation setting, respiratory muscle training with re-expansion techniques in patients following cardio-thoracic surgery represents a consolidated intervention. New devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent history of cardio-thoracic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Combined use of RESPIVOL® and RESPILIFT® (with resistive load) |
|
| Control | Sham Comparator | Combined use of RESPIVOL® and RESPILIFT® (without resistive load) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined use of RESPIVOL® and RESPILIFT® | Device | Active devices (combined) for 14 consecutive session, bid, for 15 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory muscle performance | Change of MEP (Maximum Expiratory Pressure)measure | Change from Baseline in MEP at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory muscle performance | Change of MIP (Maximum Inspiratory Pressure)measure | Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m) |
| Pulmonary volumes | Change of Static and dynamic volumes (FEV1,FVC,VC,IC,RV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrico E Clini, MD | University of Modena - Ospedale Villa Pineta | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Villa Pineta Hospital | Modena | Modena | 41026 | Italy | ||
| Villa Pineta Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23984352 | Derived | Crisafulli E, Venturelli E, Siscaro G, Florini F, Papetti A, Lugli D, Cerulli M, Clini E. Respiratory muscle training in patients recovering recent open cardiothoracic surgery: a randomized-controlled trial. Biomed Res Int. 2013;2013:354276. doi: 10.1155/2013/354276. Epub 2013 Jul 30. |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Combined use of RESPIVOL® and RESPILIFT® | Device | Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes. |
|
| Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m) |
| Pulmonary gas exchange | Change of arterial oxygen(PaO2) and use of oxygen (FiO2) in terms of PaO2/FiO2 | Enrollment (T0), at the end (T14) and after 6 months (T6m) |
| Perceived dispnoea, well being and thoracic pain | Change of perceived dispnoea, well being and thoracic pain measured through validated Visual Analogic Scale (VAS) | At enrollment (T0), every day during the treatment (T2,T4, T6, T8, T10, T12), at the end (T14) and after 6 months (T6m) |
| Perceived quality of life | Change of perceived quality of life through Saint George Respiratory Questionnaire (SGRQ), italian version | Enrollment (T0), at the end (T14) and after 6 months (T6m) |
| Modena |
| Modena |
| Italy |
| D013568 | Pathological Conditions, Signs and Symptoms |