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Completed

NCT Number: NCT02955108

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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").

Treatment and study plan

Distractive Auditory Stimuli

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

Procedure

Participants will wear headphones with no music playing

Primary outcomes

  1. Dyspnea Intensity (DI)

    Time frame: 60 Minutes

    Borg Breathlessness Scale. The Borg dyspnea scale is a single-item rating scale, ranging between 0, "nothing at all", and 10, "very, very severe (maximal)". Patients will be asked to rate their level of dyspnea during the walk test using the 10-point Borg scale after the 6MWT.64 Validity of the Borg scale for measuring dyspnea intensity has been shown.65

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2016
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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