Exercise Strategies to Motivate and Relieve Stress

NCT05776264 | Completed

• 1 other identifier: AAAU4513
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Chronic Lung Disease; Cardiopulmonary Disease

Keywords

Exercise; Stress; Lung Disease; Music; Podcast

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

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

  10 minutes (after start of walking session)

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

  10 minutes (after start of walking session)

• Borg Dyspnea and Fatigue Scale Score

  10 minutes (after start of walking session)

• Feeling Scale Score

  Up to 10 minutes (after start of walking session)

• Heart Rate

  Up to 10 minutes (after start of walking session)

Study Arms (2)

Music Condition

EXPERIMENTAL

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

Behavioral: Music Condition

Podcast Condition

PLACEBO COMPARATOR

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

Behavioral: Podcast Condition

Interventions

Music Condition BEHAVIORAL

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

Music Condition

Podcast Condition BEHAVIORAL

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

Podcast Condition

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with a cardiopulmonary disease
• Speaks and understands English

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

NewYork-Presbyterian Hospital-Columbia Pulmonary Rehabilitation

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pulmonary Heart Disease; Motor Activity; Lung Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior; Respiratory Tract Diseases

Study Officials

• Annamaria Norweg, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is masked to which condition is the experimental intervention of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: March 29, 2023
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)