COPDPhase 3NCT02594722
Metabolism and Oxygen Consumption During Functional Electrical Stimulation Cycling in COPD
A Phase 3 study testing FES-cycling and Classic cycloergometer in people with COPD, run by University Hospital, Rouen at 1 site in France.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of daily activity and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- FES-cycling and Classic cycloergometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Apr 2017
- Phase
- Phase 3
- 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
- COPD (Stade II, III or IV)
- Inform consent
Who cannot join
- Pulmonary rehabilitation contraindication
- Patient with Pacemaker
- Patient in acute exacerbation
- Patient with neurologic comorbidity
- Anemiae
Trial locations and contacts
1 site in 1 country.
About this study
Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of daily activity and quality of life. Technologies likes' neuromuscular electrical stimulation (NMES) are currently being adapted and tested to support exercise training.
The investigators hypothesized that functional electrical stimulation cycling improves VO2 and aerobic capacities during exercise compared to endurance training.
- Conditions
- COPD
- Being tested
- FES-cycling, Classic cycloergometer
- Keywords
- COPD, Functional Electrical Stimulation Cycling, Pulmonary Rehabilitation
- 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.
FES-cyclingDevice
Patients performed an endurance tests with functional electrical stimulation during 30 minutes with an oxygen uptake measure.
Classic cycloergometerDevice
Patients performed an endurance tests on classic ergometer during 30 minutes with a sham electrical stimulation with an oxygen uptake measure.
| Study group | Role | What they receive |
|---|---|---|
| One single arm group | Experimental | COPD included in a pulmonary rehabilitation program
Intervention:
Investigators used a bedside cycloergometer with electrical stimulation. COPD perform 2 measure of oxygen uptake during exercise for compare aerobic capacities:
* Functional Electrical Stimulation Cycling (FES-cycling)
* Classic Cycloergometer endurance training with a sham electrical stimulation Receives: Device: FES-cycling; Device: Classic cycloergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen uptake (VO2)
Measured: during 30 minutes exercise
Secondary outcomes (4)
Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)
Number of liters of air must be ventilated to consume 1 liter of O2
Measured: during 30 minutes exercise
Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)
Number of liters of air must be ventilated to reject 1 liter of CO2
Measured: during 30 minutes exercise
cardiac output
Measured: during 30 minutes exercise
Muscular fatigue
Measured: after 30 minutes exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startApr 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOUCHRA LAMIA, University Hospital, Rouen
- Investigators
- Clement Medrinal, Principal investigator, Groupe Hospitalier du Havre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594722
- Sponsor's protocol ID
- 2014-A01690-47
- Status last verified
- Apr 2017
- First submitted
- 29 Oct 2015
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Medrinal C, Prieur G, Combret Y, Quesada AR, Debeaumont D, Bonnevie T, Gravier FE, Dupuis Lozeron E, Quieffin J, Contal O, Lamia B. Functional Electrical Stimulation-A New Therapeutic Approach to Enhance Exercise Intensity in Chronic Obstructive Pulmonary Disease Patients: A Randomized, Controlled Crossover Trial. Arch Phys Med Rehabil. 2018 Aug;99(8):1454-1461. doi: 10.1016/j.apmr.2018.02.002. Epub 2018 Mar 7.
PubMed 29524398Medrinal C, Prieur G, Debeaumont D, Robledo Quesada A, Combret Y, Quieffin J, Contal O, Lamia B. Comparison of oxygen uptake during cycle ergometry with and without functional electrical stimulation in patients with COPD: protocol for a randomised, single-blind, placebo-controlled, cross-over trial. BMJ Open Respir Res. 2016 Apr 12;3(1):e000130. doi: 10.1136/bmjresp-2016-000130. eCollection 2016.
PubMed 27110364
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism and Oxygen Consumption During Functional Electrical Stimulation Cycling in COPD
- ClinicalTrials.gov ID
- NCT02594722
- Acronym / sponsor ID
- 2014-A01690-47
- Conditions
- COPD
- Keywords
- COPD, Functional Electrical Stimulation Cycling, Pulmonary Rehabilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 Nov 2015 (estimated)
- 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.
Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of daily activity and quality of life. Technologies likes' neuromuscular electrical stimulation (NMES) are currently being adapted and tested to support exercise training.
The investigators hypothesized that functional electrical stimulation cycling improves VO2 and aerobic capacities during exercise compared to endurance training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One single arm group | Experimental | Device: FES-cycling, Device: Classic cycloergometerCOPD included in a pulmonary rehabilitation program Intervention: Investigators used a bedside cycloergometer with electrical stimulation. COPD perform 2 measure of oxygen uptake during exercise for compare aerobic capacities: * Functional Electrical Stimulation Cycling (FES-cycling) * Classic Cycloergometer endurance training with a sham electrical stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD (Stade II, III or IV)
- Inform consent
Key exclusion criteria (5 listed)
- Pulmonary rehabilitation contraindication
- Patient with Pacemaker
- Patient in acute exacerbation
- Patient with neurologic comorbidity
- Anemiae
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 |
|---|---|---|
| FES-cyclingPatients performed an endurance tests with functional electrical stimulation during 30 minutes with an oxygen uptake measure. | Device | One single arm group |
| Classic cycloergometerPatients performed an endurance tests on classic ergometer during 30 minutes with a sham electrical stimulation with an oxygen uptake measure. | Device | One single arm group |
Primary outcome
oxygen uptake (VO2)
Time frame: during 30 minutes exercise
4 secondary outcomes
Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)
Time frame: during 30 minutes exercise
Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)
Time frame: during 30 minutes exercise
cardiac output
Time frame: during 30 minutes exercise
Muscular fatigue
Time frame: after 30 minutes exercise
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 18 Apr 2017.
- Derived from this study: PubMed 29524398Medrinal C, Prieur G, Combret Y, Quesada AR, Debeaumont D, Bonnevie T, Gravier FE, Dupuis Lozeron E, Quieffin J, Contal O, Lamia B. Functional Electrical Stimulation-A New Therapeutic Approach to Enhance Exercise Intensity in Chronic Obstructive Pulmonary Disease Patients: A Randomized, Controlled Crossover Trial. Arch Phys Med Rehabil. 2018 Aug;99(8):1454-1461. doi: 10.1016/j.apmr.2018.02.002. Epub 2018 Mar 7.
- Derived from this study: PubMed 27110364Medrinal C, Prieur G, Debeaumont D, Robledo Quesada A, Combret Y, Quieffin J, Contal O, Lamia B. Comparison of oxygen uptake during cycle ergometry with and without functional electrical stimulation in patients with COPD: protocol for a randomised, single-blind, placebo-controlled, cross-over trial. BMJ Open Respir Res. 2016 Apr 12;3(1):e000130. doi: 10.1136/bmjresp-2016-000130. eCollection 2016.
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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.
Clement Medrinal principal investigator
Groupe Hospitalier du Havre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FES-cycling and Classic cycloergometer in people with COPD, run by University Hospital, Rouen 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 2 inclusion and 5 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 18 Apr 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
oxygen uptake (VO2) (time frame: during 30 minutes exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594722, which also lists 2 linked publications.
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 18 Apr 2017.