COPDSTENDO-COPDNCT05618509
Immediate Effects of STENDO on the Walking Abilities of Patients with COPD (STENDO-COPD)
A study testing STENDO session, A six-minute walking distance test and Near Infrared Spectroscopy in people with COPD and Walking Performance, run by Elsan at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Walking Performance
- What is being tested?
- STENDO session, A six-minute walking distance test and Near Infrared Spectroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2023to 27 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COPD, Walking Performance
- Being tested
- STENDO session, A six-minute walking distance test, Near Infrared Spectroscopy, STENDO placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STENDO sessionDevice
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 testOther
Before and after STENDO session, the patient has to walk 6 minutes in a flat corridor (30m long)
Near Infrared SpectroscopyOther
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 placeboDevice
STENDO placebo : 45 minutes, on 2 legs and the pelvis, pression of 10 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Patient with STENDO | Active comparator | Not described Receives: Device: STENDO session; Other: A six-minute walking distance test; Other: Near Infrared Spectroscopy |
| Patient with placebo | Placebo comparator | Not described Receives: Other: A six-minute walking distance test; Other: Near Infrared Spectroscopy; Device: STENDO placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: Baseline to immediately after STENDO/STENDO Placebo procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start4 Jan 2023
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618509
- Sponsor's protocol ID
- 2021-A01932-39
- Acronym
- STENDO-COPD
- Status last verified
- Sep 2024
- First submitted
- 8 Nov 2022
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of STENDO on the Walking Abilities of Patients with COPD
- ClinicalTrials.gov ID
- NCT05618509
- Acronym / sponsor ID
- STENDO-COPD / 2021-A01932-39
- Conditions
- COPD, Walking Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STENDO sessionIt 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 | Device | Patient with STENDO |
| A six-minute walking distance testBefore and after STENDO session, the patient has to walk 6 minutes in a flat corridor (30m long) | Other | Patient with STENDO, Patient with placebo |
| Near Infrared SpectroscopyThe 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. | Other | Patient with STENDO, Patient with placebo |
| STENDO placeboSTENDO placebo : 45 minutes, on 2 legs and the pelvis, pression of 10 mmHg | Device | Patient with placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STENDO session, A six-minute walking distance test and Near Infrared Spectroscopy in people with COPD and Walking Performance, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.