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Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease (Parkinsonics)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Group singing
Facilitated Discussion Group
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of idiopathic PD based on UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for PD (Hughes et al. 1992).

Exclusion Criteria:

  • Patients unable to consent to the study.
  • Patients unable or unwilling to participate in weekly singing classes for 12 weeks, or unwilling to perform in a concert setting.
  • Patients with active psychiatric disturbances (agitation, active hallucinations).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Singing Intervention

    Discussion/Support Group Intervention

    Arm Description

    Twelve weekly group singing classes lasting 60-90 minutes under the direction of a professional choir director and a social worker with a music background.

    Twelve weekly 60-90 minute discussion groups led by a facilitator trained in discussion group facilitation; occurring at the same time and in the same location (next door) as experimental intervention (group singing).

    Outcomes

    Primary Outcome Measures

    Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores
    Validated 39-item questionnaire

    Secondary Outcome Measures

    Voice-Related Quality of Life
    Validated 10-item questionnaire
    Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores
    Validated Parkinson disease motor assessment scale
    Montreal Cognitive Assessment
    Validated cognitive assessment
    Geriatric Depression Scale-15
    Validated depression self-rating
    Lorig Self-efficacy scale
    5-item self-reported questionnaire
    Short Form-36
    Self-reported questionnaire assessing patients' health based on their physical and mental well-being
    Sound pressure level (decibels)
    Assessed while reading the standardized "Rainbow" passage and describing the cookie theft picture at a 50cm distance from the microphone (using a portable professional decibel meter).
    Voice jitter
    Analysis will be performed using Praat software (Boersma and Weenink, version 5.4.01, http://www.fon.hum.uva.nl/praat/). There will be 3 trials per subject holding sounds A and E for as long as possible on one breath. Sound recordings are made for each trial.
    Voice shimmer
    Analysis will be performed using Praat software (Boersma and Weenink, version 5.4.01, http://www.fon.hum.uva.nl/praat/). There will be 3 trials per subject holding sounds A and E for as long as possible on one breath. Sound recordings are made for each trial.
    Harmonic to noise ratio
    Analysis will be performed using Praat software (Boersma and Weenink, version 5.4.01, http://www.fon.hum.uva.nl/praat/). There will be 3 trials per subject holding sounds A and E for as long as possible on one breath. Sound recordings are made for each trial.

    Full Information

    First Posted
    April 25, 2016
    Last Updated
    February 28, 2017
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02753621
    Brief Title
    Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease
    Acronym
    Parkinsonics
    Official Title
    Parkinsonics: A Controlled Study of Group Singing for Quality of Life and Voice Outcomes in Parkinson Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2015 (Actual)
    Primary Completion Date
    October 1, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The overall objective of this study is to observe the effect of group Vocal performance training and performance experience on patients' reported symptoms and quality of life. The effectiveness of PD medications varies significantly in different patients depending on their symptoms. By using music-based interventions to improve symptoms that may be inadequately treated by medications, the investigators hope to improve quality of life in PD patients. "Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in Parkinson disease" (PD) is a controlled crossover behavioral intervention study of once weekly choral classes for patients with idiopathic PD (progressing toward a group performance) and once weekly discussion/support group meetings.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Singing Intervention
    Arm Type
    Experimental
    Arm Description
    Twelve weekly group singing classes lasting 60-90 minutes under the direction of a professional choir director and a social worker with a music background.
    Arm Title
    Discussion/Support Group Intervention
    Arm Type
    Active Comparator
    Arm Description
    Twelve weekly 60-90 minute discussion groups led by a facilitator trained in discussion group facilitation; occurring at the same time and in the same location (next door) as experimental intervention (group singing).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Group singing
    Intervention Description
    Weekly group singing classes led by professional choir instructor, lasting 90 minutes. 12 classes over 12 consecutive weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Facilitated Discussion Group
    Intervention Description
    Weekly facilitated discussion group led by Parkinson Disease educator, lasting 90 minutes. 12 sessions over 12 consecutive weeks.
    Primary Outcome Measure Information:
    Title
    Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores
    Description
    Validated 39-item questionnaire
    Time Frame
    Change from baseline scores at 30 weeks
    Secondary Outcome Measure Information:
    Title
    Voice-Related Quality of Life
    Description
    Validated 10-item questionnaire
    Time Frame
    Change from baseline scores at 30 weeks
    Title
    Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores
    Description
    Validated Parkinson disease motor assessment scale
    Time Frame
    Change from baseline scores at 30 weeks
    Title
    Montreal Cognitive Assessment
    Description
    Validated cognitive assessment
    Time Frame
    Change from baseline scores at 30 weeks
    Title
    Geriatric Depression Scale-15
    Description
    Validated depression self-rating
    Time Frame
    Change from baseline scores at 30 weeks
    Title
    Lorig Self-efficacy scale
    Description
    5-item self-reported questionnaire
    Time Frame
    Change from baseline scores at 30 weeks
    Title
    Short Form-36
    Description
    Self-reported questionnaire assessing patients' health based on their physical and mental well-being
    Time Frame
    Change from baseline scores at 30 weeks
    Title
    Sound pressure level (decibels)
    Description
    Assessed while reading the standardized "Rainbow" passage and describing the cookie theft picture at a 50cm distance from the microphone (using a portable professional decibel meter).
    Time Frame
    Change from baseline levels at 30 weeks
    Title
    Voice jitter
    Description
    Analysis will be performed using Praat software (Boersma and Weenink, version 5.4.01, http://www.fon.hum.uva.nl/praat/). There will be 3 trials per subject holding sounds A and E for as long as possible on one breath. Sound recordings are made for each trial.
    Time Frame
    Change from baseline values at 30 weeks
    Title
    Voice shimmer
    Description
    Analysis will be performed using Praat software (Boersma and Weenink, version 5.4.01, http://www.fon.hum.uva.nl/praat/). There will be 3 trials per subject holding sounds A and E for as long as possible on one breath. Sound recordings are made for each trial.
    Time Frame
    Change from baseline values at 30 weeks
    Title
    Harmonic to noise ratio
    Description
    Analysis will be performed using Praat software (Boersma and Weenink, version 5.4.01, http://www.fon.hum.uva.nl/praat/). There will be 3 trials per subject holding sounds A and E for as long as possible on one breath. Sound recordings are made for each trial.
    Time Frame
    Change from baseline values at 30 weeks
    Other Pre-specified Outcome Measures:
    Title
    Feasibility
    Description
    At least 80% of participants attending at least 9 of 12 singing classes and the final performance
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of idiopathic PD based on UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for PD (Hughes et al. 1992). Exclusion Criteria: Patients unable to consent to the study. Patients unable or unwilling to participate in weekly singing classes for 12 weeks, or unwilling to perform in a concert setting. Patients with active psychiatric disturbances (agitation, active hallucinations).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexander Pantelyat, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease

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