Exercise Strategies to Motivate and Relieve Stress

Exercise Strategies to Motivate and Relieve Stress in Adults With Chronic Cardiopulmonary Conditions

The goal of this clinical trial is to evaluate exercise strategies that motivate and relive stress in adults with cardiopulomnary conditions. The goals of this study are as follows:

• To explore the feasibility (how easily it can be done) of using self-selected music during exercise training for adults with cardiopulmonary conditions.
• To assess patient satisfaction of self-selected music with exercise for adults with cardiopulmonary conditions.
• To explore the immediate effects of self-selected music on mood and symptoms (shortness of breath and fatigue) compared with listening to a podcast during their exercise training session

Participants will:

• Select 5-7 songs and 1 podcast to listen to during their treatment session
• Walk on the treadmill while either listening to a podcast or music
• Fill out surveys about their mood, symptoms (shortness of breath and fatigue), music/podcast, and exercise

Study Overview

• Status: Completed
• Conditions: Chronic Lung Disease; Cardiopulmonary Disease
• Intervention / Treatment: Behavioral: Music Condition; Behavioral: Podcast Condition

Detailed Description

Music2Move aims to assess if tailored music (music choices that are set to a certain beats per minute and are self-selected by the participant) improves mood while exercising in adults with chronic lung diseases, to ultimately motivate them to engage in physical activity more frequently. This trial will be conducted during their pulmonary rehabilitation session for two consecutive sessions. Researchers will flip a coin for a random order of music condition or no music condition for each participant. Researchers will meet with participants before the trial to collect music selections to be played during the pulmonary rehabilitation session. Mood will be assessed every 2 minutes during the trial using the Feeling Scale to examine the effect of tailored music selections on the participants tolerance for exercise and maximal limit exercise exertion during the session. Heart rate, oxygen level, fatigue, and affect (immediate emotional response), measure of breathlessness (feelings of shortness of breath) will also be assessed before and after the trial to examine the affect that tailored music has on physical measures of exercise. The results of this study could aid in finding motivational tools to improve exercise participation and adherence in adults with chronic respiratory disease.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mallory Moore, MS; Phone Number: 336-708-0348; Email: mm5799@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • NewYork-Presbyterian Hospital-Columbia Pulmonary Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Diagnosed with a cardiopulmonary disease
• Speaks and understands English

Exclusion Criteria:

• Require a hearing aid or have a hearing impairment that interferes with their ability to hear music or use headphones during the study.
• Unable to engage in physical activity due to health conditions including neurological or musculoskeletal diseases.
• Require ≥6 liters of supplemental oxygen during pulmonary rehabilitation sessions.
• Younger than 21 years old.
• Older than 85 years old.
• Have uncontrolled anginal symptoms.
• Unable to exercise on a treadmill.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music Condition; 3 self-selected music choices to be played during the study	Behavioral: Music Condition; During one of the sessions, participants will listen to music while walking on the treadmill for 10 minutes.
Placebo Comparator: Podcast Condition; One self-selected podcast choice to be played during the study	Behavioral: Podcast Condition; During one of the sessions, participant will listen to a podcast for 10 minutes while walking on the treadmill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FACIT TS-G Score	The Functional Assessment of Chronic Illness Therapy Treatment Satisfaction General (FACIT TS-G) satisfaction item will be administered to measure participants' satisfaction with the exercise session. This is a 1-item measure with scores range from 0 (poor) to 4 (excellent) with a higher score indicating a better outcome, with a goal of a at least a mean rating of "2."	Day 1 (after the 10 minute walking session)
Total Number of Participants Recruited	A priori success benchmark of recruitment efficiency will be the ability to recruit 12 participants for the study.	Up to 12 weeks
Percentage of Ecological Momentary Assessment Data Collected	A priori success benchmark for collecting ecological momentary assessment data would be to collect ≥80% of mood (Feeling Scale and HR) data as proposed using 2-minute intervals over two, 10-minute exercise sessions.	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on Positive Items from the Positive and Negative Affect Scale-SF (PANAS-SF)	The Positive and Negative Affect Scale-SF (PANAS-SF) is a scale that consists of different words that describe feelings and emotions. 10 positive items will be used to assess affect. Scores range from 1-5 with a higher score indicating a a more positive affect. The final score is the sum of the scores for the positive items which ranges from 10 (minimum) to 50 (maximum) with a higher score indicating a more positive affect.	10 minutes (after start of walking session)
Score on Positive Items from the Physical Activity Affect Scale (PAAS)	The PAAS is a self-report measure administered during exercise for measuring affect, only the 3 positive items will be administered. Scores range from 0-4 with a "4" indicating a better outcome. The mean of the three positive items on the scale will be taken to calculate the final score which ranges from 0 (minimum) to 4 (maximum), with a higher score indicating a better outcome.	10 minutes (after start of walking session)
Borg Dyspnea and Fatigue Scale Score	The Borg Dyspnea and Fatigue Scale are 1-item scales used to measure shortness of breath and fatigue. The score range from 0 (nothing at all) to 10 (very, very severe) with a lower score indicating feeling less of this symptom.	10 minutes (after start of walking session)
Feeling Scale Score	The Feeling Scale is 1-item that measures mood ranging from -5 indicating "very bad" to +5 indicating "very good" when asked how they are feeling.	Up to 10 minutes (after start of walking session)
Heart Rate	Pulsoximeter will be used to measure heart rate.	Up to 10 minutes (after start of walking session)
Dyspnea Anxiety Scale	Dyspnea Anxiety Scale is a 1-item, 0-100 Visual Analog Scale with scores ranging from 0-100. 0 meaning "not at all anxious" and 100 meaning "extremely anxious."	10 minutes (after start of walking session)

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Annamaria Norweg, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Stress; Podcast; Lung Disease; Music
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Pulmonary Heart Disease
• Other Study ID Numbers: AAAU4513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No