The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults With Chronic Respiratory Diseases

NCT ID: NCT02955108

Last Updated: 2021-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-27

Study Completion Date

2018-11-14

Brief Summary

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The objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance. Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate increased self-paced walk distance and enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The long-term goal of this study is to increase physical activity in adults with COPD and RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli in the form of music.

Detailed Description

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This randomized clinical trial will use a cross-over design. The research will include two within-subject factors, music versus no music and time. Each subject will be randomized a single time to receive either music first then no music, or alternatively, no music first then music during two walk tests.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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music first then no music

Group Type EXPERIMENTAL

Distractive Auditory Stimuli

Intervention Type PROCEDURE

Participants will self-select 1 music piece from a list of choices to keep the rhythm and tempo consistent throughout the 6MWT. The instructions to participants for selecting the music will be standardized. TThe music volume will be standardized to be "moderately loud" as rated by participants for the music condition. Participants will not be specifically instructed to synchronize their walking movements with the music tempo. The music is based on a cognitive therapy (distraction) strategy conceptual framework. Music will be played during the 6MWT (in-task) only.

No Distractive Auditory Stimuli

Intervention Type PROCEDURE

Participants will wear headphones with no music playing

no music first then music

Group Type EXPERIMENTAL

Distractive Auditory Stimuli

Intervention Type PROCEDURE

Participants will self-select 1 music piece from a list of choices to keep the rhythm and tempo consistent throughout the 6MWT. The instructions to participants for selecting the music will be standardized. TThe music volume will be standardized to be "moderately loud" as rated by participants for the music condition. Participants will not be specifically instructed to synchronize their walking movements with the music tempo. The music is based on a cognitive therapy (distraction) strategy conceptual framework. Music will be played during the 6MWT (in-task) only.

No Distractive Auditory Stimuli

Intervention Type PROCEDURE

Participants will wear headphones with no music playing

Interventions

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Distractive Auditory Stimuli

Participants will self-select 1 music piece from a list of choices to keep the rhythm and tempo consistent throughout the 6MWT. The instructions to participants for selecting the music will be standardized. TThe music volume will be standardized to be "moderately loud" as rated by participants for the music condition. Participants will not be specifically instructed to synchronize their walking movements with the music tempo. The music is based on a cognitive therapy (distraction) strategy conceptual framework. Music will be played during the 6MWT (in-task) only.

Intervention Type PROCEDURE

No Distractive Auditory Stimuli

Participants will wear headphones with no music playing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* English speaking
* aged 40 years or older, with physician-diagnosed COPD
* a flow volume loop with a FEV1/FVC of \< 0.70 in the past 12 months

* medically cleared to participate in NYULMC's pulmonary rehabilitation program.

Exclusion Criteria

* Inability to exercise due to musculoskeletalor neurological dysfunction
* Inability to walk independently (unaided)
* deafness or severe hearing impairment requiring hearing aids
* mMRC score = 0 ("I only get breathlessness with strenuous exercise").
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Maria Norweg

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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16-01676

Identifier Type: -

Identifier Source: org_study_id

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