Increasing Physical Activity in COPD Through Rhythmically Enhanced Music

NCT03655028 | Completed Results DMC

• 1 other identifier: E2803-R
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The VA cares for nearly one million Veterans with COPD at a cost of more than $5.5 billion annually. COPD profoundly impairs quality of life as it limits ability to work, to maintain physical exertion and to engage in social activities. Hospital-based rehab can decrease the need for inpatient and outpatient medical care and can improve exercise capacity, quality of life and, possibly, decrease mortality. Unfortunately, access to hospital-based VA rehab is insufficient and, over time, the few Veterans who attend experience progressive loss of functional gains. The investigators reason that the proposed home-based exercise program augmented by patient-tailored, RAS-enhanced music will overcome the many limitations of hospital-based rehab. Through this innovative program, the investigators expect to enhance the benefits of rehab and better maintain them over time. The easy applicability of this innovative, accessible and economical program has the potential to modify the spiraling pattern of increasing disability and reduce health-care cost and mortality in Veterans with COPD. In 2021, the investigators obtained an 'Administrative Project Modification' to the parent COPD study in which they will include patients recovering from prolonged COVID19 hospitalization. Specifically, the investigators will use the novel RAS-enhanced music exercise program developed for the parent grant in patients recovering from COVID19. The main goal of the modified proposal for COVID19 patients will be to compare the efficacy of a 12-week, home-based exercise program augmented by RAS-therapeutic music and strength training to 12-weeks usual care and strength training in patients recovering from COVID 19.

Conditions

COPD Patients and Patients Recovering From COVID19

Keywords

COPD; Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Six-minute Walk Distance

  Patients will be instructed to walk as fast as they can without running for six minutes. The test will be conducted according to ATS standards. Distance will be recorded in meters walked. Outcomes will be compared between the intervention groups.

  12 weeks

Secondary Outcomes (4)

• Volume of Daily Physical Activity

  12 weeks

• Six-minute Walk Distance

  24 weeks

• Quality of Life Physical Function

  12 weeks

• Quality of Life Mental Health

  12-weeks

Other Outcomes (1)

• Adherence to Training Sessions Protocol

  12 weeks

Study Arms (2)

RAS-music group

EXPERIMENTAL

Home-based, exercise program augmented with rhythmically auditory stimulation enhanced music

Behavioral: rhythmically auditory stimulation enhanced music

Control group

ACTIVE COMPARATOR

Home-based, exercise program without rhythmically auditory stimulation enhanced music

Behavioral: control

Interventions

rhythmically auditory stimulation enhanced music BEHAVIORAL

Patients in the intervention group will listen to music enhanced by rhythmic auditory stimulation while engaging in a 12-week home-based exercise program

RAS-music group

control BEHAVIORAL

Patients in the control group will not listen to music while engaging in a 12-week home-based exercise program

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patients:
• =\< 40 yr. of age
• FEV1 =\< 70%
• FEV1/FVC \<70%
• Mean SpO2 88% at peak exercise (with or without oxygen supplementation)
• COVID19 patients
• \>=18 yrs. of age
• Previous hospital and/or emergency room visit for laboratory-confirmed COVID-19 diagnosis.
• Able to walk independently
• Mean SpO2 88% at peak exercise (with or without oxygen supplementation)
• Ability to hear music

You may not qualify if:

• COPD patients:
• Respiratory infection/COPD exacerbation within the previous four weeks
• Exercise-limiting heart disease
• Congestive heart failure - i.e., New York Heart Association Class III or IV
• Positive stress test or other indicators of heart disease or complaints of angina during the stress test
• Exercise-limiting peripheral arterial disease
• Stops walking due to intermittent claudication
• Stops exercise for arthritic pain in knee or hips
• Inability to walk on the treadmill
• Any unforeseen illness or disability that would preclude exercise testing or training
• Participation in a formal exercise program within the previous 12-weeks
• COVID patients:
• Able to walk more than 550 meters during a standard 6-minute walk test
• Exercise limiting heart disease
• Complaints of angina during the 6- minute walk distance tests or other indicators of exercise-limiting heart disease

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

The study was interrupted by the COVID-19 pandemic. Initially we were going to analyze data generated from metabolic stress testing. Due to the large amounts of saliva produced from these measures, we dropped metabolic stress testing from the protocol and substituted data generated from the 6MW test instead. Less subjects were enrolled than planned also due to the pandemic.

Results Point of Contact

• Title: Eileen Collins
• Organization: Edward Hines Jr., VA Hospital

ecollins@uic.edu

312-3550118

Study Officials

• Franco Laghi, MD

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both investigator and outcome assessor will be blinded to patient allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial in which COPD patients in the intervention group and COVID19 patient in the intervention group will undergo a home-based, exercise program augmented with RAS-enhanced music while COPD patients in the control group and COVID19 patients in the control group will undergo a home-based, exercise program without music. Outcomes of the home-based exercise program with music will be compared to the outcomes of home-based exercise alone. Outcomes are listed below.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: October 1, 2018
• Primary Completion: September 11, 2023
• Study Completion: November 14, 2023
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)