NCT02831465

Brief Summary

Maximal Voluntary Ventilation (MVV) correlates well with maximal exercise capacity and is used to assess the ventilatory function during exercise in COPD (Chronic Obstructive Pulmonary Disease) patients. Dynamic hyperinflation (DH) often occurs during MVV in COPD and is believed to be due to expiratory flow limitation. The present study is intended to assess whether DH can also occur during MVV in normal subjects without expiratory flow limitation.

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

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

April 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 2, 2017

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

July 11, 2016

Last Update Submit

February 1, 2017

Conditions

Keywords

Dynamic hyperinflationMaximal Voluntary VentilationInspiratory capacityhealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Frequency which induces Dynamic Hyperinflation

    We analyze Frequency of Maximal Voluntary Ventilation (MVV) which induces a significant decrease of the Inspiratory Capacity (IC) post MVV compared to the IC at rest.

    day one

Secondary Outcomes (8)

  • Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Expiratory Volume in one second

    day one

  • Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Vital Capacity

    day one

  • Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Expiratory Flows at 25%, 50% and 75% of Forced Vital Capacity

    day one

  • Correlation between the frequency which induces Dynamic Hyperinflation (DH) and age

    day one

  • Correlation between the frequency which induces Dynamic Hyperinflation (DH) and body mass index

    day one

  • +3 more secondary outcomes

Study Arms (1)

healthy subjects

EXPERIMENTAL

Subjects with normal lung function between 40 and 70 years old.

Behavioral: Healthy Subjects

Interventions

Subjects with normal lung function performed MVV at increasing breathing frequencies and maximal tidal volume, from 10 to 100 cycles per minute. Inspiratory capacity (IC) was measured at rest and after each 12 seconds of MVV in order to detect DH. From the moment DH appeared at a given frequency, only one additional MVV at a higher breathing frequency was conducted to confirm DH.

healthy subjects

Eligibility Criteria

Age40 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • History of asthma, obstructive syndrome on basic lung function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU St. Pierre

Brussels, Brussels Capital, 1000, Belgium

RECRUITING

Study Officials

  • Vincent Ninane, MD, PhD

    University Hospital Center Saint Pierre chest service

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 13, 2016

Study Start

April 1, 2015

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

February 2, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations