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

• ClinicalTrials.gov Identifier: NCT03923660
• Recruitment Status: Unknown
• First Posted: April 22, 2019
• Last Update Posted: April 22, 2019
• Sponsor: Centre Hospitalier Universitaire de Besancon
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Besancon

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease Severe	Other: Incremental Concentric-eccentric exercise test; Other: Incremental Eccentric-concentric exercise test	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD
• Actual Study Start Date: September 20, 2018
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: December 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Concentric-eccentric; Concentric-eccentric	Other: Incremental Concentric-eccentric exercise test; Patients will perform incremental exercise test on semi recumbent eccentric ergometer
Experimental: Eccentric-concentric; Eccentric-concentric	Other: Incremental Eccentric-concentric exercise test; Patients will perform incremental exercise test on semi recumbent concentric ergometer

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

CHU de Besançon

Besançon, France, 25000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

More Information

• Responsible Party: Centre Hospitalier Universitaire de Besancon
• ClinicalTrials.gov Identifier: NCT03923660
• Other Study ID Numbers: P/2018/374
• First Posted: April 22, 2019
• Last Update Posted: April 22, 2019
• Last Verified: September 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:

COPD; breathing pattern; exercise; concentric; eccentric

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases