Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease

Study Overview
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Brief Summary
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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.

Official Title
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Parkinsonics: A Controlled Study of Group Singing for Quality of Life and Voice Outcomes in Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Group singing
* Behavioral: Facilitated Discussion Group


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Singing Intervention<br>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. | Behavioral: Group singing<br>* Weekly group singing classes led by professional choir instructor, lasting 90 minutes. 12 classes over 12 consecutive weeks.<br>|
| Active Comparator: Discussion/Support Group Intervention<br>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). | Behavioral: Facilitated Discussion Group<br>* Weekly facilitated discussion group led by Parkinson Disease educator, lasting 90 minutes. 12 sessions over 12 consecutive weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores | Validated 39-item questionnaire | Change from baseline scores at 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice-Related Quality of Life | Validated 10-item questionnaire | Change from baseline scores at 30 weeks | 
| Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores | Validated Parkinson disease motor assessment scale | Change from baseline scores at 30 weeks | 
| Montreal Cognitive Assessment | Validated cognitive assessment | Change from baseline scores at 30 weeks | 
| Geriatric Depression Scale-15 | Validated depression self-rating | Change from baseline scores at 30 weeks | 
| Lorig Self-efficacy scale | 5-item self-reported questionnaire | Change from baseline scores at 30 weeks | 
| Short Form-36 | Self-reported questionnaire assessing patients' health based on their physical and mental well-being | Change from baseline scores at 30 weeks | 
| 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). | Change from baseline levels at 30 weeks | 
| 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. | Change from baseline values at 30 weeks | 
| 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. | Change from baseline values at 30 weeks | 
| 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. | Change from baseline values at 30 weeks |