NCT03238209

Brief Summary

To evaluate the compatibility and correlation between noninvasive surface respiratory electromyography and invasive transesophageal diaphragmatic electromyography measurements, as facilitating indicators of neural respiratory drive evaluation during treadmill exercise. Transesophageal diaphragmatic EMG (EMGdi,es) and surface inspiratory EMG, including surface diaphragmatic EMG (EMGdi,sur), surface parasternal intercostal muscle EMG (EMGpara) and surface sternocleidomastoid EMG (EMGsc) were detected simultaneously during increasing capacity exercise in stable patients with COPD. EMGdi,es, EMGdi,sur, EMGpara and EMGsc was quantified using root mean square (RMS), which represent as RMSdi,es, RMSdi,sur, RMSpara and RMSsc.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

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

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

August 1, 2017

Last Update Submit

August 2, 2017

Conditions

Keywords

neural respiratory drivetransesophageal diaphragmatic EMGsurface diaphragmatic EMGsurface sternocleidomastoid EMGsurface parasternal intercostal muscle EMG

Outcome Measures

Primary Outcomes (1)

  • transesophageal diaphragmatic EMG

    transesophageal diaphragmatic EMG was measured using a multipair esophageal electrode consisting of nine consecutive coils composed of five electrode pairs positioned in the esophagus and traversing the cardia

    30 minute

Secondary Outcomes (3)

  • Surface diaphragmatic EMG

    30 minute

  • Surface parasternal EMG

    30 minute

  • Surface sternocleidomastoid EMG

    30 minute

Study Arms (1)

Exercise testing

EXPERIMENTAL

The test consisted of a steady-state resting period of 3 min followed by 1 min of unloaded pedaling at 60 cycles/min for each individual; the exercise load was increased by 10 W each min until the test had to be stopped because symptoms prevented further exercise. After test results were recorded, EMGdi,es and each surface inspiratory EMG of maximal exercise capacity were analysed.

Diagnostic Test: Exercise testing

Interventions

Exercise testingDIAGNOSTIC_TEST

The test consisted of a steady-state resting period of 3 min followed by 1 min of unloaded pedaling at 60 cycles/min for each individual; the exercise load was increased by 10 W each min until the test had to be stopped because symptoms prevented further exercise. After test results were recorded, EMGdi,es and each surface inspiratory EMG of maximal exercise capacity were analysed.

Exercise testing

Eligibility Criteria

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

You may qualify if:

  • post bronchodilator forced expiratory volume in 1 s \[FEV1\]/forced vital capacity \[FVC\] ,70% and FEV1 ,50% of the predicted value);
  • bronchial dilation test (BDT) negative.

You may not qualify if:

  • acute exacerbation in the previous 4 weeks;
  • use of oral corticosteroids within 4 weeks;
  • smoking more than 10 cigarettes daily;
  • history of other respiratory, cardiovascular, neuromuscular, and musculoskeletal diseases that could interfere with the exercise performance and inspiratory muscle activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiration Disorders

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

July 1, 2016

Primary Completion

December 15, 2016

Study Completion

December 30, 2016

Last Updated

August 3, 2017

Record last verified: 2017-08