Immediate Effects of STENDO on the Walking Abilities of Patients With COPD (STENDO-COPD)

Study Overview
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Brief Summary
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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.

Official Title
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Immediate Effects of STENDO on the Walking Abilities of Patients With COPD

Conditions
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COPD, Walking Performance

Intervention / Treatment
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* Device: STENDO session
* Other: A six-minute walking distance test
* Other: Near Infrared Spectroscopy
* Device: STENDO placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient with STENDO<br> | Device: STENDO session<br>* 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<br>Other: A six-minute walking distance test<br>* Before and after STENDO session, the patient has to walk 6 minutes in a flat corridor (30m long)<br>Other: Near Infrared Spectroscopy<br>* 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.<br>|
| Placebo Comparator: Patient with placebo<br> | Other: A six-minute walking distance test<br>* Before and after STENDO session, the patient has to walk 6 minutes in a flat corridor (30m long)<br>Other: Near Infrared Spectroscopy<br>* 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.<br>Device: STENDO placebo<br>* STENDO placebo : 45 minutes, on 2 legs and the pelvis, pression of 10 mmHg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |