Music and Perceived Rate of Exertion | NCT01833260

Studies
Music and Perceived Rate of Exertion

NCT01833260

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Jul 18, 2014Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

COPD

Interventions

Music

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Apr 10, 2013

First Submission Date that Met QC Criteria

Apr 12, 2013

First Posted Date

Apr 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2014

Last Update Posted Date

Jul 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

G.Reychler, Doctor in Physiotherapy, Cliniques universitaires Saint-Luc- Université Catholique de LouvainPrincipal Investigator

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With music	Experimental	Pulmonary rehabilitation with music in the room	Behavioral: Music
Without music	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Music	Behavioral		With music

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of exertion		After 1 hour

Secondary Outcomes

Measure	Description	Time Frame
Dyspnea	Using a visual analogue scale	After 1 hour
Hospital Anxiety Depression Scale	The score of anxiety and depression will be measured

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

participate to only session of one condition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques universitaires Saint-Luc		Brussels			Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25587172	Derived	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.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation