NCT02392715

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases dyspnea and improves exercise capacity. Whether IMT combined with GET adds a supplementary benefit in the rehabilitation of COPD patients is however uncertain.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2015

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

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

1.5 years

First QC Date

March 13, 2015

Last Update Submit

March 27, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Inspiratory muscle trainingGeneral exercise trainingpulmonary rehabilitationchronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity (six minute walking test)

    exercise capacity will be assessed by a six minute walking test

    12 weeks

Secondary Outcomes (2)

  • Quality of Life (St-George's Respiratory questionnaire)

    12 weeks

  • Maximal inspiratory pressure (MicroRPM by MicroMedical)

    12 weeks

Study Arms (2)

Intervention cohort

EXPERIMENTAL

36 sessions of 60 - 75 minutes with a frequency of 3x/week 30' endurance training, 15' strength training, 15' inspiratory muscle training with Threshold by Respironics Inspiratory muscle training intensity: 15% of maximal inspiratory pressure (PiMax) during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax.

Device: Inspiratory muscle training with Threshold by respironics

Control cohort

SHAM COMPARATOR

36 sessions of 60 - 75 minutes with a frequency of 3x/week 30' endurance training, 15' strength training, 15' sham inspiratory muscle training with Threshold by Respironics Sham inspiratory muscle training intensity : 5 centimeters of water (cmH20)

Device: Sham Inspiratory muscle training

Interventions

Inspiratory muscle training with Threshold by respironicsDEVICE

Inspiratory muscle training 15 minutes, 3x/weeks, 36 sessions Intensity: 15% of PiMax during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax.

Intervention cohort
Sham Inspiratory muscle trainingDEVICE

with Threshold by respironics 15 minutes, 3x/weeks, 36 sessions Intensity: 5 centimeters of water (cmH20)

Control cohort

Eligibility Criteria

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

You may qualify if:

  • COPD demonstrated by spirometry using Gold Criteria
  • Patient referred by a pneumologist to the ambulatory pulmonary rehabilitation program at the Riviera-Chablais Hospital, Monthey
  • Patient with maximal inspiratory pressure \< 60 cmH20
  • Patient older than 40 years

You may not qualify if:

  • Orthopaedic or neurological troubles that could slant the 6 minute walking test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Stéphanie Vaudan, BSc

    stephanie.vaudan@hopitalrivierachablais.ch

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Vaudan, BSc

CONTACT

+41 24 473 18 99stephanie.vaudan@hopitalrivierachablais.ch

Nicolas Garin, MD

CONTACT

+ 41 24 473 80 75nicolas.garin@hopitalrivierachablais.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stéphanie Vaudan, board-certified respiratory therapist

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 19, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

March 30, 2015

Record last verified: 2015-03