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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD; Walking Performance
• Intervention / Treatment: Device: STENDO session; Other: A six-minute walking distance test; Other: Near Infrared Spectroscopy; Device: STENDO placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tarbes, France, 65000
    • Recruiting
    • Polyclinique de l'Ormeau
    • Contact: Mars Labrunee, Dr; Phone Number: 06 10 97 68 70; Email: drlabrunee@polyclinique-Ormeau.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient with STENDO	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); Other: 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.
Placebo Comparator: Patient with placebo	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); Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Elsan
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Actual): May 27, 2024
• Study Completion (Actual): May 27, 2024

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021-A01932-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No