NCT05618509Completed
Immediate Effects of STENDO on the Walking Abilities of Patients with COPD (STENDO-COPD)
Immediate Effects of STENDO on the Walking Abilities of Patients with COPD
Source: ClinicalTrials.gov · Last updated 5 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 8 Nov 2022
- Start date
- 4 Jan 2023
- Primary completion date
- 27 May 2024
- Lead sponsor
- Elsan
- Diseases
- COPD
- NCT number
- NCT05618509
What you commit to
- Study type: Interventional
- Participants enrolled: 32
- From 4 Jan 2023 to the primary completion date, 27 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Dementia with MMSE (Mini mental state examination) \<24/30
- Heart failure
- Open fracture, bleeding or healing wound
- 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
Other
- Neurological or osteo-articular pathology impeding walking.
- 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
- 3rd degree burn
- Liver cirrhosis
- Bedsore
- Refusal to participate in the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Polyclinique de l'Ormeau Coordinator of this site? Confirm its status | Tarbes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.