Chronic Obstructive Pulmonary Disease SevereCONvEXNCT03923660
Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD
A study testing Incremental Concentric-eccentric exercise test and Incremental Eccentric-concentric exercise test in people with Chronic Obstructive Pulmonary Disease Severe, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Pulmonary rehabilitation (PR) based on concentric exercise training has become an integral component in the treatment of patients with chronic obstructive pulmonary disease (COPD), improving functional capacities while diminishing symptoms and improving quality of life. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Severe
- What is being tested?
- Incremental Concentric-eccentric exercise test and Incremental Eccentric-concentric exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2018to Dec 2019
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe COPD (FEV1 [forced expiratory volume in 1 second] / FVC [forced vital capacity] < 70% et FEV1 < 50%)
- Informed consent
- Affiliation to a social security scheme
Who cannot join
- Effort oxygen therapy
- Cardiovascular, neuromuscular or musculoskeletal disorders that can provide significant dyspnea or limit exercise
- Legal incapacity
- Low or no cooperation anticipated
Trial locations and contacts
1 site in 1 country.
About this study
Pulmonary rehabilitation (PR) based on concentric exercise training has become an integral component in the treatment of patients with chronic obstructive pulmonary disease (COPD), improving functional capacities while diminishing symptoms and improving quality of life.
However, the response to concentric exercise training is heterogeneous from one COPD patient to another. The inability of some COPD patients to achieve the exercise intensities required to stress limb muscles due to severe ventilatory limitation could partially explain their poor response to training.
Read more
Endurance exercise with eccentric muscle contractions could be an interesting alternative to concentric exercise because it produces greater muscle force through its lower metabolic cost. Eccentric exercise could allow patients with severe airflow limitation to perform prolonged exercise sessions with sufficient intensity to improve muscle function.
Nevertheless, a recent study performed in healthy young subjects reported that eccentric exercise induced a more hyperpneic breathing pattern (i.e., lower tidal volume and higher breathing frequency) that concentric for a given minute ventilation.
The main objective of CONvEX study is to compare ventilatory adaptation between two modalities of exercise performed on cycle ergometer (concentric versus eccentric) in severe COPD patients.
Read the detailed description
Pulmonary rehabilitation (PR) based on concentric exercise training has become an integral component in the treatment of patients with chronic obstructive pulmonary disease (COPD), improving functional capacities while diminishing symptoms and improving quality of life.
However, the response to concentric exercise training is heterogeneous from one COPD patient to another. The inability of some COPD patients to achieve the exercise intensities required to stress limb muscles due to severe ventilatory limitation could partially explain their poor response to training.
Endurance exercise with eccentric muscle contractions could be an interesting alternative to concentric exercise because it produces greater muscle force through its lower metabolic cost. Eccentric exercise could allow patients with severe airflow limitation to perform prolonged exercise sessions with sufficient intensity to improve muscle function.
Nevertheless, a recent study performed in healthy young subjects reported that eccentric exercise induced a more hyperpneic breathing pattern (i.e., lower tidal volume and higher breathing frequency) that concentric for a given minute ventilation.
The main objective of CONvEX study is to compare ventilatory adaptation between two modalities of exercise performed on cycle ergometer (concentric versus eccentric) in severe COPD patients.
- Being tested
- Incremental Concentric-eccentric exercise test, Incremental Eccentric-concentric exercise test
- Keywords
- COPD, breathing pattern, exercise, concentric, eccentric
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental Concentric-eccentric exercise testOther
Patients will perform incremental exercise test on semi recumbent eccentric ergometer
Incremental Eccentric-concentric exercise testOther
Patients will perform incremental exercise test on semi recumbent concentric ergometer
| Study group | Role | What they receive |
|---|---|---|
| Concentric-eccentric | Experimental | Concentric-eccentric Receives: Other: Incremental Concentric-eccentric exercise test |
| Eccentric-concentric | Experimental | Eccentric-concentric Receives: Other: Incremental Eccentric-concentric exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory adaptation
Breathing frequency/tidal volume ratio at the maximum common minute ventilation.
Measured: week 1
Secondary outcomes (6)
Dynamic hyperinflation
Dynamic hyperinflation will be assessed through iterative inspiratory capacity (IC) measurment during exercise. A decrease in IC >150 mL compared to resting levels at any time point during exercise will be considered as dynamic hyperinflation.
Measured: week 1
Brachial muscle enrollment
2.4 GHz electromyographic activity of biceps brachii recorded using surface electrod (Cometa Wave Plus wireless EMG)
Measured: week 1
Quadriceps muscle enrollment
2.4 GHz electromyographic activity of vastus lateralis recorded using surface electrod (Cometa Wave Plus wireless EMG)
Measured: week 1
Ventilatory efficiency
Dead volume/Tidal volume ratio
Measured: week 1
Ventilatory efficiency
Minute ventilation/Carbon dioxide production ratio
Measured: week 1
Tolerance
Borg modified scale [ranging from 0 to 10] for dyspnoea 0 indicates no dyspnoea and 10 the maximum dyspnoea
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start20 Sep 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease SevereStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923660
- Sponsor's protocol ID
- P/2018/374
- Acronym
- CONvEX
- Status last verified
- Sep 2018
- First submitted
- 2 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD
- ClinicalTrials.gov ID
- NCT03923660
- Acronym / sponsor ID
- CONvEX / P/2018/374
- Keywords
- COPD, breathing pattern, exercise, concentric, eccentric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Apr 2019 (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.
Pulmonary rehabilitation (PR) based on concentric exercise training has become an integral component in the treatment of patients with chronic obstructive pulmonary disease (COPD), improving functional capacities while diminishing symptoms and improving quality of life.
However, the response to concentric exercise training is heterogeneous from one COPD patient to another. The inability of some COPD patients to achieve the exercise intensities required to stress limb muscles due to severe ventilatory limitation could partially explain their poor response to training.
Endurance exercise with eccentric muscle contractions could be an interesting alternative to concentric exercise because it produces greater muscle force through its lower metabolic cost. Eccentric exercise could allow patients with severe airflow limitation to perform prolonged exercise sessions with sufficient intensity to improve muscle function.
Nevertheless, a recent study performed in healthy young subjects reported that eccentric exercise induced a more hyperpneic breathing pattern (i.e., lower tidal volume and higher breathing frequency) that concentric for a given minute ventilation.
The main objective of CONvEX study is to compare ventilatory adaptation between two modalities of exercise performed on cycle ergometer (concentric versus eccentric) in severe COPD patients.
Detailed description
Pulmonary rehabilitation (PR) based on concentric exercise training has become an integral component in the treatment of patients with chronic obstructive pulmonary disease (COPD), improving functional capacities while diminishing symptoms and improving quality of life.
However, the response to concentric exercise training is heterogeneous from one COPD patient to another. The inability of some COPD patients to achieve the exercise intensities required to stress limb muscles due to severe ventilatory limitation could partially explain their poor response to training.
Endurance exercise with eccentric muscle contractions could be an interesting alternative to concentric exercise because it produces greater muscle force through its lower metabolic cost. Eccentric exercise could allow patients with severe airflow limitation to perform prolonged exercise sessions with sufficient intensity to improve muscle function.
Nevertheless, a recent study performed in healthy young subjects reported that eccentric exercise induced a more hyperpneic breathing pattern (i.e., lower tidal volume and higher breathing frequency) that concentric for a given minute ventilation.
The main objective of CONvEX study is to compare ventilatory adaptation between two modalities of exercise performed on cycle ergometer (concentric versus eccentric) in severe COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentric-eccentric | Experimental | Other: Incremental Concentric-eccentric exercise testConcentric-eccentric |
| Eccentric-concentric | Experimental | Other: Incremental Eccentric-concentric exercise testEccentric-concentric |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe COPD (FEV1 [forced expiratory volume in 1 second] / FVC [forced vital capacity] < 70% et FEV1 < 50%)
- Informed consent
- Affiliation to a social security scheme
Key exclusion criteria (4 listed)
- Effort oxygen therapy
- Cardiovascular, neuromuscular or musculoskeletal disorders that can provide significant dyspnea or limit exercise
- Legal incapacity
- Low or no cooperation anticipated
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 |
|---|---|---|
| Incremental Concentric-eccentric exercise testPatients will perform incremental exercise test on semi recumbent eccentric ergometer | Other | Concentric-eccentric |
| Incremental Eccentric-concentric exercise testPatients will perform incremental exercise test on semi recumbent concentric ergometer | Other | Eccentric-concentric |
Primary outcome
Ventilatory adaptation
Time frame: week 1
Breathing frequency/tidal volume ratio at the maximum common minute ventilation.
6 secondary outcomes
Dynamic hyperinflation
Time frame: week 1
Brachial muscle enrollment
Time frame: week 1
Quadriceps muscle enrollment
Time frame: week 1
Ventilatory efficiency
Time frame: week 1
Ventilatory efficiency
Time frame: week 1
Tolerance
Time frame: week 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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 Incremental Concentric-eccentric exercise test and Incremental Eccentric-concentric exercise test in people with Chronic Obstructive Pulmonary Disease Severe, run by Centre Hospitalier Universitaire de Besancon 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Apr 2019. 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.
Are results available for this study?
Results are not available in the source record.
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?
Ventilatory adaptation (time frame: week 1). 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 22 Apr 2019.