Chronic Lung DiseaseNCT05776264
Exercise Strategies to Motivate and Relieve Stress
A study testing Music Condition and Podcast Condition in people with Chronic Lung Disease and Cardiopulmonary Disease, run by Columbia University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Lung Disease, Cardiopulmonary Disease
- What is being tested?
- Music Condition and Podcast Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with a cardiopulmonary disease
- Speaks and understands English
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian Hospital-Columbia Pulmonary Rehabilitation
New York, New York, 10032
About this study
Official title: 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
Read more
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
Read the 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.
- Conditions
- Chronic Lung Disease, Cardiopulmonary Disease
- Being tested
- Music Condition, Podcast Condition
- Keywords
- Exercise, Stress, Lung Disease, Music, Podcast
- Medical subject headings
- Pulmonary Heart Disease, Motor Activity, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ConditionBehavioural
During one of the sessions, participants will listen to music while walking on the treadmill for 10 minutes.
Podcast ConditionBehavioural
During one of the sessions, participant will listen to a podcast for 10 minutes while walking on the treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Music Condition | Experimental | 3 self-selected music choices to be played during the study Receives: Behavioral: Music Condition |
| Podcast Condition | Placebo comparator | One self-selected podcast choice to be played during the study Receives: Behavioral: Podcast Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 10 minutes (after start of walking session)
Heart Rate
Pulsoximeter will be used to measure heart rate.
Measured: 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."
Measured: 10 minutes (after start of walking session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start29 Mar 2023
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annamaria Norweg, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776264
- Sponsor's protocol ID
- AAAU4513
- Status last verified
- Dec 2023
- First submitted
- 8 Mar 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Strategies to Motivate and Relieve Stress in Adults With Chronic Cardiopulmonary Conditions
- ClinicalTrials.gov ID
- NCT05776264
- Acronym / sponsor ID
- AAAU4513
- Conditions
- Chronic Lung Disease, Cardiopulmonary Disease
- Keywords
- Exercise, Stress, Lung Disease, Music, Podcast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music Condition | Experimental | Behavioral: Music Condition3 self-selected music choices to be played during the study |
| Podcast Condition | Placebo comparator | Behavioral: Podcast ConditionOne self-selected podcast choice to be played during the study |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with a cardiopulmonary disease
- Speaks and understands English
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music ConditionDuring one of the sessions, participants will listen to music while walking on the treadmill for 10 minutes. | Behavioural | Music Condition |
| Podcast ConditionDuring one of the sessions, participant will listen to a podcast for 10 minutes while walking on the treadmill. | Behavioural | Podcast Condition |
Primary outcome
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."
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.
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.
6 secondary outcomes
Score on Positive Items from the Positive and Negative Affect Scale-SF (PANAS-SF)
Time frame: 10 minutes (after start of walking session)
Score on Positive Items from the Physical Activity Affect Scale (PAAS)
Time frame: 10 minutes (after start of walking session)
Borg Dyspnea and Fatigue Scale Score
Time frame: 10 minutes (after start of walking session)
Feeling Scale Score
Time frame: Up to 10 minutes (after start of walking session)
Heart Rate
Time frame: Up to 10 minutes (after start of walking session)
Dyspnea Anxiety Scale
Time frame: 10 minutes (after start of walking session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annamaria Norweg, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Condition and Podcast Condition in people with Chronic Lung Disease and Cardiopulmonary Disease, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT TS-G Score (time frame: Day 1 (after the 10 minute walking session)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.