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Increasing Physical Activity in COPD Through Rhythmically Enhanced Music

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ClinicalTrials.gov Identifier: NCT03655028
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE August 29, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
six-minute walk distance [ Time Frame: 12 weeks ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03655028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • volume of daily physical activity [ Time Frame: 12 weeks ]
    Volume of daily physical activity over a seven day period will be recorded using a triaxial accelerometer worn on the hip (actigraph)
  • six-minute walk distance [ Time Frame: 24 weeks ]
    To determine whether, 24-weeks after randomization, gains in 6-minute walk distance and perceived functional improvements will be sustained to a greater extent in the rhythmic auditory stimulation enhanced music group than in the control group the six-minutes walk test will be repeated 24-weeks after randomization. During the six-minute walk test 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 29, 2018)
responsiveness to rehabilitation (exercise duration on the constant-load treadmill test) [ Time Frame: 12 weeks ]
The investigators will assess impact of clinical factors on responsiveness to rehabilitation (exercise duration on the constant-load treadmill test) achieved with and without concurrent use of RAS-music (Exploratory Objective). Patient will perform a constant-load treadmill test before and after intervention and the impact of clinical factors (anxiety, depression, self-efficacy, adherence to the 12-week program, adherence to follow-up and number and severity of exacerbations, systemic inflammation, quadriceps strength, recruitment and fatigue, quadriceps function and dimension after rehabilitation) on changes in exercise duration will be explored.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Increasing Physical Activity in COPD Through Rhythmically Enhanced Music
Official Title  ICMJE Increasing Physical Activity in COPD Through Rhythmically Enhanced Music
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.
Detailed Description Rationale: In COPD, hospital-based pulmonary rehabilitation can improve symptoms, functional status, and quality of life and decrease unscheduled physician visits, emergency room visits, hospitalizations, and possibly, mortality. Despite the well documented efficacy, hospital-based rehab remains inadequate due to insufficient access, acceptance and sustainability. This has triggered a growing interest in home-based rehab programs. Patients enrolled in home-based programs, however, may exercise at low intensities to avoid dyspnea/fatigue, limiting the potential benefits of exercise training. Accordingly, it is essential to develop innovative home-based programs that decrease exercise-induced dyspnea and fatigue while ensuring sufficient exercise intensity to produce sustainable physiologic benefit. Recent data suggest that rhythmically auditory stimulation (RAS) using music may constitute such an innovative strategy. Music can diminish exercise-induced dyspnea/fatigue allowing patients to tolerate more challenging physical activity and obtain a greater benefit from rehab. Music also can induce entrainment of motor responses such as walking. The investigators thus plan to capitalize on both the sensorimotor coupling of gait with RAS-enhanced music and the mitigating effect of music over exercise-induced dyspnea/fatigue. Specifically, the investigators propose to compare the efficacy of a 12-week, home-based exercise program augmented by patient-tailored, RAS-enhanced music to a 12-week traditional home-based exercise program in patients with COPD. Hypothesis: (H1) Compared to patients randomized to a home-based, exercise program without music (control group), patients randomized to a home-based, exercise program augmented with RAS-enhanced music (intervention group) will demonstrate (H1a, primary hypothesis) greater increase in 6-minute walk distance, (H1b) greater increase in walking time on a constant-load treadmill test protocol, (H1c) reduced dyspnea during a constant-load treadmill test protocol, and (H1d) greater increases in health-related quality of life. In addition (H2), they will accumulate greater volume of physical activity (actigraphy) and (H3) will better sustain these benefits over time. Lastly (Explorative Objective), the investigators will assess the mechanistic impact physiological and psychological phenotype and clinical factors on responsiveness to rehabilitation (duration constant-load treadmill test) achieved with and without concurrent use of RAS-music. Methods: The proposed study is a randomized, controlled clinical trial in which 170 patients will be randomized into a home-based, exercise program without music or a home-based exercise program augmented with RAS-enhanced music. Patients will receive 12-weeks of home-based training per group assignment (at least three times weekly) followed by 12-weeks of follow-up to assess the sustainability of the investigators' novel intervention. Testing will be carried out at baseline and at 6, 12 and 24 weeks. Testing will include pulmonary function test, 6-minute walk tests, constant-load treadmill test, physical activity quantification, measurements of dyspnea, quality of life, and objective quantification of quadriceps dimensions (ultrasonography) and strength/fatigue (magnetic stimulation of the femoral nerve). Analysis: In the principal analysis of the primary outcome measure (6-minute walk distance) the investigators will use a mixed-model analysis that includes, treatment, time and treatment-by-time interaction terms. This model will automatically account for missing data-where missing at random is assumed. The investigators will conduct a sensitivity analysis based on the results of the mixed model analysis to determine which other assumptions regarding missing data might produce different results. One component of the sensitivity analysis will include adjustment for baseline demographic and health covariates. A linear regression model and a mixed model ANOVA will be used to assess the impact of clinical confounders (Explorative Objective). Scientific contribution: These data will provide a solid foundation to determine the physiologic impact of the rehab strategy. This innovative, practical and economical pulmonary rehabilitation strategy has the potential to create a paradigm shift in the care of the many Veterans with COPD who have no access to pulmonary rehabilitation
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial in which patients with COPD in the intervention group will undergo a home-based, exercise program augmented with RAS-enhanced music while patients with COPD in the control group will undergo a home-based, exercise program without music
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Both investigator and outcome assessor will be blinded to patient allocation
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE
  • Behavioral: rhythmically auditory stimulation enhanced music
    Patients in the intervention group will listen to music enhanced by rhythmic auditory stimulation while engaging in a 12-week home-based exercise program
  • Behavioral: control
    Patients in the control group will not listen to music while engaging in a 12-week home-based exercise program
Study Arms  ICMJE
  • Experimental: RAS-music group
    Home-based, exercise program augmented with rhythmically auditory stimulation enhanced music
    Intervention: Behavioral: rhythmically auditory stimulation enhanced music
  • Active Comparator: Control group
    Home-based, exercise program without rhythmically auditory stimulation enhanced music
    Intervention: Behavioral: control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2018)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • FEV1 70%
  • FEV1/FVC <70%
  • Mean SpO2 88% at peak exercise (with or without oxygen supplementation)
  • Ability to hear music

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Susan A O'Connell Schnell, RN MHA (708) 202-7817 susan.oconnell@va.gov
Contact: Franco Laghi, MD (708) 202-8387 franco.laghi@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03655028
Other Study ID Numbers  ICMJE E2803-R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Franco Laghi, MD Edward Hines Jr. VA Hospital, Hines, IL
PRS Account VA Office of Research and Development
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP