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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03923660
Other study ID # P/2018/374
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 20, 2018
Est. completion date December 2019

Study information

Verified date September 2018
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Effort oxygen therapy

- Cardiovascular, neuromuscular or musculoskeletal disorders that can provide significant dyspnea or limit exercise

- Legal incapacity

- Low or no cooperation anticipated

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Incremental Concentric-eccentric exercise test
Patients will perform incremental exercise test on semi recumbent eccentric ergometer
Incremental Eccentric-concentric exercise test
Patients will perform incremental exercise test on semi recumbent concentric ergometer

Locations

Country Name City State
France CHU de Besançon Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ventilatory adaptation Breathing frequency/tidal volume ratio at the maximum common minute ventilation. week 1
Secondary 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. week 1
Secondary Brachial muscle enrollment 2.4 GHz electromyographic activity of biceps brachii recorded using surface electrod (Cometa Wave Plus wireless EMG) week 1
Secondary Quadriceps muscle enrollment 2.4 GHz electromyographic activity of vastus lateralis recorded using surface electrod (Cometa Wave Plus wireless EMG) week 1
Secondary Ventilatory efficiency Dead volume/Tidal volume ratio week 1
Secondary Ventilatory efficiency Minute ventilation/Carbon dioxide production ratio week 1
Secondary Tolerance Borg modified scale [ranging from 0 to 10] for dyspnoea 0 indicates no dyspnoea and 10 the maximum dyspnoea week 1
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