COPD, Walking Performance
Conditions
Brief 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.
Interventions
DEVICESTENDO session
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
OTHERA six-minute walking distance test
Before and after STENDO session, the patient has to walk 6 minutes in a flat corridor (30m long)
OTHERNear Infrared Spectroscopy
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.
DEVICESTENDO placebo
STENDO placebo : 45 minutes, on 2 legs and the pelvis, pression of 10 mmHg
Sponsors
European Clinical Trial Experts Network
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic chronic obstructive pulmonary disease (COPD) attested by a Tiffeneau ratio \<70% * Not oxygen dependent * Oriented for an ambulatory effort rehabilitation program in after-care and rehabilitation * Negative urine pregnancy test in women of childbearing age * Affiliation to a social security scheme or beneficiary of such a scheme * Patient having signed the free and informed consent
Exclusion criteria
* Neurological or osteo-articular pathology impeding walking. * Dementia with MMSE (Mini mental state examination) \<24/30 * Heart failure * Covid + in the previous 3 months * Major surgery in the year preceding the session * Heavy abdominal, pelvic and lower limb cosmetic surgery in the year preceding the session * Impaired comprehension and/or expression * Being simultaneously on oral contraception (pill) and smoking (more than 10 cigarettes per day) * Severe unbalanced high blood pressure * severe peripheral neuropathy * Colostomy * Open fracture, bleeding or healing wound * 3rd degree burn * Liver cirrhosis * Bedsore * Have 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 4 * Refusal to participate in the study
Design outcomes
Primary
| Measure | 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 |
Countries
France
Outcome results
None listed