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Exercise Strategies to Motivate and Relieve Stress

Primary Purpose

Chronic Lung Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Condition
Podcast Condition
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lung Disease focused on measuring Exercise, Stress, Lung Disease, Music, Podcast

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Diagnosed with a chronic lung condition 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. Older than 85 years old. Have uncontrolled anginal symptoms. Unable to exercise on a treadmill.

Sites / Locations

  • NewYork-Presbyterian Hospital-Columbia Pulmonary RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Music Condition

Podcast Condition

Arm Description

3 self-selected music choices to be played during the study

One self-selected podcast choice to be played during the study

Outcomes

Primary Outcome Measures

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."
Total Number of Participants Recruited
A priori success benchmark of recruitment efficiency will be the ability to recruit 12 participants for the study.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Heart Rate
Pulsoximeter will be used to measure heart rate.
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."

Full Information

First Posted
March 8, 2023
Last Updated
April 6, 2023
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05776264
Brief Title
Exercise Strategies to Motivate and Relieve Stress
Official Title
Exercise Strategies to Motivate and Relieve Stress in Adults With Chronic Lung Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate exercise strategies that motivate and relive stress in adults with chronic lung 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 chronic lung conditions. To assess patient satisfaction of self-selected music with exercise for adults with chronic lung 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 3-4 songs and 1 podcast to listen to during their treatment session Walk on the treadmill while either listening to a podcast or music for 10 minutes Fill out surveys about their mood, symptoms (shortness of breath and fatigue), music/podcast, and exercise
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lung Disease
Keywords
Exercise, Stress, Lung Disease, Music, Podcast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will listen to either self-selected music and then a podcast or podcast and then self-selected music on two consecutive sessions, based on a randomized order.
Masking
Participant
Masking Description
Participant is masked to which condition is the experimental intervention of the study.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Condition
Arm Type
Experimental
Arm Description
3 self-selected music choices to be played during the study
Arm Title
Podcast Condition
Arm Type
Placebo Comparator
Arm Description
One self-selected podcast choice to be played during the study
Intervention Type
Behavioral
Intervention Name(s)
Music Condition
Intervention Description
During one of the sessions, participants will listen to music while walking on the treadmill for 10 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Podcast Condition
Intervention Description
During one of the sessions, participant will listen to a podcast for 10 minutes while walking on the treadmill.
Primary Outcome Measure Information:
Title
FACIT TS-G Score
Description
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."
Time Frame
Day 1 (after the 10 minute walking session)
Title
Total Number of Participants Recruited
Description
A priori success benchmark of recruitment efficiency will be the ability to recruit 12 participants for the study.
Time Frame
Up to 12 weeks
Title
Percentage of Ecological Momentary Assessment Data Collected
Description
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.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Score on Positive Items from the Positive and Negative Affect Scale-SF (PANAS-SF)
Description
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.
Time Frame
10 minutes (after start of walking session)
Title
Score on Positive Items from the Physical Activity Affect Scale (PAAS)
Description
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.
Time Frame
10 minutes (after start of walking session)
Title
Borg Dyspnea and Fatigue Scale Score
Description
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.
Time Frame
10 minutes (after start of walking session)
Title
Feeling Scale Score
Description
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.
Time Frame
Up to 10 minutes (after start of walking session)
Title
Heart Rate
Description
Pulsoximeter will be used to measure heart rate.
Time Frame
Up to 10 minutes (after start of walking session)
Title
Dyspnea Anxiety Scale
Description
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."
Time Frame
10 minutes (after start of walking session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed with a chronic lung condition 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. Older than 85 years old. Have uncontrolled anginal symptoms. Unable to exercise on a treadmill.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mallory Moore, MS
Phone
336-708-0348
Email
mm5799@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annamaria Norweg, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NewYork-Presbyterian Hospital-Columbia Pulmonary Rehabilitation
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annamaria Norweg, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise Strategies to Motivate and Relieve Stress

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