Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease

Parkinson Disease Clinical Trial

— Parkinsonics  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753621
• Other study ID #: IRB00065196
• Status: Completed
• Phase: Phase 2
• First received: April 25, 2016
• Last updated: February 28, 2017
• Start date: December 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 31, 2016
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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).

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Group singing
Weekly group singing classes led by professional choir instructor, lasting 90 minutes. 12 classes over 12 consecutive weeks.
• Facilitated Discussion Group
Weekly facilitated discussion group led by Parkinson Disease educator, lasting 90 minutes. 12 sessions over 12 consecutive weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility	At least 80% of participants attending at least 9 of 12 singing classes and the final performance	12 weeks
Primary	Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores	Validated 39-item questionnaire	Change from baseline scores at 30 weeks
Secondary	Voice-Related Quality of Life	Validated 10-item questionnaire	Change from baseline scores at 30 weeks
Secondary	Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores	Validated Parkinson disease motor assessment scale	Change from baseline scores at 30 weeks
Secondary	Montreal Cognitive Assessment	Validated cognitive assessment	Change from baseline scores at 30 weeks
Secondary	Geriatric Depression Scale-15	Validated depression self-rating	Change from baseline scores at 30 weeks
Secondary	Lorig Self-efficacy scale	5-item self-reported questionnaire	Change from baseline scores at 30 weeks
Secondary	Short Form-36	Self-reported questionnaire assessing patients' health based on their physical and mental well-being	Change from baseline scores at 30 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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