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
About this trial
This is an interventional treatment trial for Parkinson Disease
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).
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
NCT ID
NCT02753621
First Posted
April 25, 2016
Last Updated
February 28, 2017
Sponsor
Johns Hopkins University
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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