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Completed

NCT Number: NCT05776264

Exercise Strategies to Motivate and Relieve Stress

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

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Key information

Conditions

Chronic Lung Disease Behavior Cardiopulmonary Disease Cardiovascular Diseases Heart Diseases Lung Diseases Motor Activity Pulmonary Heart Disease Respiratory Tract Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NewYork-Presbyterian Hospital-Columbia Pulmonary Rehabilitation

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Music Condition

Behavioral

During one of the sessions, participants will listen to music while walking on the treadmill for 10 minutes.

Podcast Condition

Behavioral

During one of the sessions, participant will listen to a podcast for 10 minutes while walking on the treadmill.

Primary outcomes

  1. FACIT TS-G Score

    Time frame: Day 1 (after the 10 minute walking session)

    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."

  2. Total Number of Participants Recruited

    Time frame: Up to 12 weeks

    A priori success benchmark of recruitment efficiency will be the ability to recruit 12 participants for the study.

  3. Percentage of Ecological Momentary Assessment Data Collected

    Time frame: Up to 12 weeks

    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.

Secondary outcomes

  1. Score on Positive Items from the Positive and Negative Affect Scale-SF (PANAS-SF)

    Time frame: 10 minutes (after start of walking session)

    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.

  2. Score on Positive Items from the Physical Activity Affect Scale (PAAS)

    Time frame: 10 minutes (after start of walking session)

    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.

  3. Borg Dyspnea and Fatigue Scale Score

    Time frame: 10 minutes (after start of walking session)

    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.

  4. Feeling Scale Score

    Time frame: Up to 10 minutes (after start of walking session)

    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.

  5. Heart Rate

    Time frame: Up to 10 minutes (after start of walking session)

    Pulsoximeter will be used to measure heart rate.

  6. Dyspnea Anxiety Scale

    Time frame: 10 minutes (after start of walking session)

    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."

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2023
Registry last updated
Dec 28, 2023

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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