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

COPD Clinical Trial

— STENDO-COPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618509
• Other study ID #: 2021-A01932-39
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Elsan
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jeanfrancois.oudet[@]free.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Walking Performance

Intervention

Device:
• STENDO 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

Other:
• A six-minute walking distance test
Before and after STENDO session, the patient has to walk 6 minutes in a flat corridor (30m long)
• Near 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.

Device:
• STENDO placebo
STENDO placebo : 45 minutes, on 2 legs and the pelvis, pression of 10 mmHg

Locations

Country	Name	City	State
France	Polyclinique de l'Ormeau	Tarbes

Sponsors (2)

Lead Sponsor	Collaborator
Elsan	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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