NCT03923660

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 22, 2019

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

April 2, 2019

Last Update Submit

April 19, 2019

Conditions

Keywords

COPDbreathing patternexerciseconcentriceccentric

Outcome Measures

Primary Outcomes (1)

  • Ventilatory adaptation

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

    week 1

Secondary Outcomes (6)

  • Dynamic hyperinflation

    week 1

  • Brachial muscle enrollment

    week 1

  • Quadriceps muscle enrollment

    week 1

  • Ventilatory efficiency

    week 1

  • Ventilatory efficiency

    week 1

  • +1 more secondary outcomes

Study Arms (2)

Concentric-eccentric

EXPERIMENTAL

Concentric-eccentric

Other: Incremental Concentric-eccentric exercise test

Eccentric-concentric

EXPERIMENTAL

Eccentric-concentric

Other: Incremental Eccentric-concentric exercise test

Interventions

Patients will perform incremental exercise test on semi recumbent eccentric ergometer

Concentric-eccentric

Patients will perform incremental exercise test on semi recumbent concentric ergometer

Eccentric-concentric

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Effort oxygen therapy
  • Cardiovascular, neuromuscular or musculoskeletal disorders that can provide significant dyspnea or limit exercise
  • Legal incapacity
  • Low or no cooperation anticipated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 22, 2019

Study Start

September 20, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 22, 2019

Record last verified: 2018-09

Locations