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

Elsan

Status: Completed

Conditions: COPD; Walking Performance

Treatments: Device: STENDO placebo; Device: STENDO session; Other: A six-minute walking distance test; Other: Near Infrared Spectroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05618509

2021-A01932-39

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Patient with STENDO

Active Comparator group

Treatment:

Other: Near Infrared Spectroscopy

Device: STENDO session

Other: A six-minute walking distance test

Patient with placebo

Placebo Comparator group

Treatment:

Other: Near Infrared Spectroscopy

Device: STENDO placebo

Other: A six-minute walking distance test