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Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD (CONvEX)

Primary Purpose

Chronic Obstructive Pulmonary Disease Severe

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Incremental Concentric-eccentric exercise test
Incremental Eccentric-concentric exercise test
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease Severe focused on measuring COPD, breathing pattern, exercise, concentric, eccentric

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Besançon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Concentric-eccentric

Eccentric-concentric

Arm Description

Concentric-eccentric

Eccentric-concentric

Outcomes

Primary Outcome Measures

Ventilatory adaptation
Breathing frequency/tidal volume ratio at the maximum common minute ventilation.

Secondary Outcome Measures

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.
Brachial muscle enrollment
2.4 GHz electromyographic activity of biceps brachii recorded using surface electrod (Cometa Wave Plus wireless EMG)
Quadriceps muscle enrollment
2.4 GHz electromyographic activity of vastus lateralis recorded using surface electrod (Cometa Wave Plus wireless EMG)
Ventilatory efficiency
Dead volume/Tidal volume ratio
Ventilatory efficiency
Minute ventilation/Carbon dioxide production ratio
Tolerance
Borg modified scale [ranging from 0 to 10] for dyspnoea 0 indicates no dyspnoea and 10 the maximum dyspnoea

Full Information

First Posted
April 2, 2019
Last Updated
April 19, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03923660
Brief Title
Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD
Acronym
CONvEX
Official Title
Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease Severe
Keywords
COPD, breathing pattern, exercise, concentric, eccentric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concentric-eccentric
Arm Type
Experimental
Arm Description
Concentric-eccentric
Arm Title
Eccentric-concentric
Arm Type
Experimental
Arm Description
Eccentric-concentric
Intervention Type
Other
Intervention Name(s)
Incremental Concentric-eccentric exercise test
Intervention Description
Patients will perform incremental exercise test on semi recumbent eccentric ergometer
Intervention Type
Other
Intervention Name(s)
Incremental Eccentric-concentric exercise test
Intervention Description
Patients will perform incremental exercise test on semi recumbent concentric ergometer
Primary Outcome Measure Information:
Title
Ventilatory adaptation
Description
Breathing frequency/tidal volume ratio at the maximum common minute ventilation.
Time Frame
week 1
Secondary Outcome Measure Information:
Title
Dynamic hyperinflation
Description
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.
Time Frame
week 1
Title
Brachial muscle enrollment
Description
2.4 GHz electromyographic activity of biceps brachii recorded using surface electrod (Cometa Wave Plus wireless EMG)
Time Frame
week 1
Title
Quadriceps muscle enrollment
Description
2.4 GHz electromyographic activity of vastus lateralis recorded using surface electrod (Cometa Wave Plus wireless EMG)
Time Frame
week 1
Title
Ventilatory efficiency
Description
Dead volume/Tidal volume ratio
Time Frame
week 1
Title
Ventilatory efficiency
Description
Minute ventilation/Carbon dioxide production ratio
Time Frame
week 1
Title
Tolerance
Description
Borg modified scale [ranging from 0 to 10] for dyspnoea 0 indicates no dyspnoea and 10 the maximum dyspnoea
Time Frame
week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

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Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD

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