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

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 Overview

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Besançon, France, 25000
        • CHU de Besancon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concentric-eccentric
Patients will perform incremental exercise test on semi recumbent eccentric ergometer
Experimental: Eccentric-concentric
Patients will perform incremental exercise test on semi recumbent concentric ergometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilatory adaptation
Time Frame: week 1
Breathing frequency/tidal volume ratio at the maximum common minute ventilation.
week 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic hyperinflation
Time Frame: week 1
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
Brachial muscle enrollment
Time Frame: week 1
2.4 GHz electromyographic activity of biceps brachii recorded using surface electrod (Cometa Wave Plus wireless EMG)
week 1
Quadriceps muscle enrollment
Time Frame: week 1
2.4 GHz electromyographic activity of vastus lateralis recorded using surface electrod (Cometa Wave Plus wireless EMG)
week 1
Ventilatory efficiency
Time Frame: week 1
Dead volume/Tidal volume ratio
week 1
Ventilatory efficiency
Time Frame: week 1
Minute ventilation/Carbon dioxide production ratio
week 1
Tolerance
Time Frame: week 1
Borg modified scale [ranging from 0 to 10] for dyspnoea 0 indicates no dyspnoea and 10 the maximum dyspnoea
week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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