Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease

Phase 2

Completed

• Conditions: Parkinson Disease
• Interventions: Behavioral: Group singing; Behavioral: Facilitated Discussion Group

• Registration Number: NCT02753621
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-01
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Primary Completion: 2016-10-01
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Singing Intervention	Group singing	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.
Discussion/Support Group Intervention	Facilitated Discussion Group	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).

Primary Outcome Measures

Name	Time	Method
Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores	Change from baseline scores at 30 weeks	Validated 39-item questionnaire

Secondary Outcome Measures

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