NCT01833260

Brief Summary

The aim of this study was to evaluate the effect of listening to ambient music on the perceived exertion rate during pulmonary rehabilitation for chronic obstructive pulmonary disease patients.

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

Timeline
Completed

Started May 2013

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

First Submitted

Initial submission to the registry

April 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

1 month

First QC Date

April 10, 2013

Last Update Submit

July 17, 2014

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Rate of exertion

    After 1 hour

Secondary Outcomes (2)

  • Dyspnea

    After 1 hour

  • Hospital Anxiety Depression Scale

    After 1 hour

Study Arms (2)

With music

EXPERIMENTAL

Pulmonary rehabilitation with music in the room

Behavioral: Music

Without music

NO INTERVENTION

Interventions

MusicBEHAVIORAL
With music

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participate in the program for at least one month after the initial medical investigation, be free of exacerbations for 1 month and have maintained exactly the same program session for both evaluated sessions

You may not qualify if:

  • participate to only session of one condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Belgium

Location

Related Publications (1)

  • Reychler G, Mottart F, Boland M, Wasterlain E, Pieters T, Caty G, Liistro G. Influence of ambient music on perceived exertion during a pulmonary rehabilitation session: a randomized crossover study. Respir Care. 2015 May;60(5):711-7. doi: 10.4187/respcare.03671. Epub 2015 Jan 13.

    PMID: 25587172DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in Physiotherapy

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 16, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations

BE(1)