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Completed

NCT Number: NCT05618509

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

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Walking Performance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinique de l'Ormeau

Tarbes, 65000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

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.

STENDO placebo

Device

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

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..

    Time frame: Baseline to immediately after STENDO/STENDO Placebo procedure

Sponsors and collaborators

Lead sponsor

Elsan

Other

Collaborators

  • European Clinical Trial Experts Network

Registry information

Official study title

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

Acronym: STENDO-COPD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 16, 2022
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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