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NCT05618509
Immediate Effects of STENDO on the Walking Abilities of Patients With COPD (STENDO-COPD)
Conditions: COPD, Walking Performance
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 32
Sponsor: Elsan
Location: France
Summary
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.
Eligibility Criteria
Inclusion Criteria:Symptomatic chronic obstructive pulmonary disease (COPD) attested by a Tiffeneau ratio <70%Not oxygen dependentOriented for an ambulatory effort rehabilitation program in after-care and rehabilitationNegative urine pregnancy test in women of childbearing ageAffiliation to a social security scheme or beneficiary of such a schemePatient having signed the free and informed consentExclusion Criteria:Neurological or osteo-articular pathology impeding walking.Dementia with MMSE (Mini mental state examination) <24/30Heart failureCovid + in the previous 3 monthsMajor surgery in the year preceding the sessionHeavy abdominal, pelvic and lower limb cosmetic surgery in the year preceding the sessionImpaired comprehension and/or expressionBeing simultaneously on oral contraception (pill) and smoking (more than 10 cigarettes per day)Severe unbalanced high blood pressuresevere peripheral neuropathyColostomyOpen fracture, bleeding or healing wound3rd degree burnLiver cirrhosisBedsoreHave prohibitions and restrictions with a history of phlebitis or recent progressive venous thrombosis (less than 6 months) or arterial disease of the lower limbs stage 3 and 4Refusal to participate in the study
Source: ClinicalTrials.gov (NCT05618509). StuddyBuddy aggregates publicly available trial information.