Overview

This trial is active, not recruiting.

Condition parkinson disease
Treatments group singing, facilitated discussion group
Phase phase 2
Sponsor Johns Hopkins University
Start date December 2015
End date October 2016
Trial size 32 participants
Trial identifier NCT02753621, IRB00065196

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
group singing
Weekly group singing classes led by professional choir instructor, lasting 90 minutes. 12 classes over 12 consecutive weeks.
(Active Comparator)
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).
facilitated discussion group
Weekly facilitated discussion group led by Parkinson Disease educator, lasting 90 minutes. 12 sessions over 12 consecutive weeks.

Primary Outcomes

Measure
Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores
time frame: Change from baseline scores at 30 weeks

Secondary Outcomes

Measure
Voice-Related Quality of Life
time frame: Change from baseline scores at 30 weeks
Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores
time frame: Change from baseline scores at 30 weeks
Montreal Cognitive Assessment
time frame: Change from baseline scores at 30 weeks
Geriatric Depression Scale-15
time frame: Change from baseline scores at 30 weeks
Lorig Self-efficacy scale
time frame: Change from baseline scores at 30 weeks
Short Form-36
time frame: Change from baseline scores at 30 weeks
Sound pressure level (decibels)
time frame: Change from baseline levels at 30 weeks
Voice jitter
time frame: Change from baseline values at 30 weeks
Voice shimmer
time frame: Change from baseline values at 30 weeks
Harmonic to noise ratio
time frame: Change from baseline values at 30 weeks

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

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).

Additional Information

Official title Parkinsonics: A Controlled Study of Group Singing for Quality of Life and Voice Outcomes in Parkinson Disease
Principal investigator Alexander Pantelyat, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Johns Hopkins University.