Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European Clinical Trial Experts Network | OTHER |
Not provided
Not provided
Not provided
The STENDO process is a heart rate synchronized massage system initially validated for the treatment of lymphedema. It is a combination enveloping the lower limbs up to the abdomen. The massage system induces pressure from the ankles to the abdomen between each heartbeat. This technique would also allow an improvement of endothelial function by a greater release of nitric oxide. Thus the capacity for physical exercise is potentially improved.
The use of STENDO has never been evaluated in COPD (Chronic obstructive pulmonary disease) where physical capacity is impaired with, in particular, the presence of endothelial dysfunction. STENDO may improve walking performance. If these hypotheses are validated, the STENDO could be positioned as a complement to the exercise rehabilitation strategies offered to symptomatic COPD patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with STENDO | Active Comparator |
| |
| Patient with placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STENDO session | Device | It is a combination enveloping the lower limbs up to the abdomen. The massage system induces pressure from the ankles to the abdomen between each heartbeat. The capacity for physical exercise is potentially improved. STENDO : 45 minutes, 2 legs and the pelvis, pression of 65mm Hg |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in the 6-minute walk test distance after the performance of the STENDO/STENDO Placebo session compared to the value of the initial 6-minute walk test.. | Baseline to immediately after STENDO/STENDO Placebo procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique de l'Ormeau | Tarbes | 65000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| A six-minute walking distance test | Other | Before and after STENDO session, the patient has to walk 6 minutes in a flat corridor (30m long) |
|
| Near Infrared Spectroscopy | Other | The goal is to measure the evolution of the oxygen consumption of the right leg during an effort on a bicycle at constant power for 5 minutes. |
|
| STENDO placebo | Device | STENDO placebo : 45 minutes, on 2 legs and the pelvis, pression of 10 mmHg |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |