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

NCT05618509 | Completed

• 1 other identifier: 2021-A01932-39
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Walking Performance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patient with STENDO

ACTIVE COMPARATOR

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

Patient with placebo

PLACEBO COMPARATOR

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

Interventions

STENDO session DEVICE

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

Patient with STENDO

A six-minute walking distance test OTHER

Before and after STENDO session, the patient has to walk 6 minutes in a flat corridor (30m long)

Patient with STENDO; Patient with placebo

Near Infrared Spectroscopy OTHER

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.

Patient with STENDO; Patient with placebo

STENDO placebo DEVICE

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

Patient with placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• rd degree burn
• Liver cirrhosis
• Bedsore

Sponsors & Collaborators

• Elsan: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Polyclinique de l'Ormeau

Tarbes, 65000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: January 4, 2023
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)