NCT02186340

Brief Summary

The improvement in inspiratory muscle function might result in beneficial changes in breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing pattern during an incremental cycle exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

July 3, 2014

Last Update Submit

August 28, 2015

Conditions

Chronic Obstructive Pulmonary DiseaseMuscle Weakness Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in breathing pattern during an incremental cycle exercise test

    At comparable levels of ventilation breathing frequency, inspiratory time (Ti), expiratory time (Te), total time of the respiratory cycle (Ttot), inspiratory duty cycle (Ti/Ttot), and inspiratory flow rates will be compared.

    Baseline and 8 weeks follow-up

Study Arms (1)

Inspiratory muscle training

EXPERIMENTAL
Procedure: Inspiratory muscle training

Interventions

Inspiratory muscle trainingPROCEDURE
Inspiratory muscle training

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically stable COPD patients
  • maximal inspiratory pressure \<100% of the predicted normal value

You may not qualify if:

  • Major comorbidities preventing successful participation in an 8 week exercise training intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Charususin N, Gosselink R, McConnell A, Demeyer H, Topalovic M, Decramer M, Langer D. Inspiratory muscle training improves breathing pattern during exercise in COPD patients. Eur Respir J. 2016 Apr;47(4):1261-4. doi: 10.1183/13993003.01574-2015. Epub 2016 Feb 25. No abstract available.

    PMID: 26917617DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rik PT Gosselink, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Daniel Langer

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 10, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 31, 2015

Record last verified: 2015-08

Locations

BE(1)