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Completed

NCT Number: NCT02753621

Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Group singing

Behavioral

Weekly group singing classes led by professional choir instructor, lasting 90 minutes. 12 classes over 12 consecutive weeks.

Facilitated Discussion Group

Behavioral

Weekly facilitated discussion group led by Parkinson Disease educator, lasting 90 minutes. 12 sessions over 12 consecutive weeks.

Primary outcomes

  1. Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores

    Time frame: Change from baseline scores at 30 weeks

    Validated 39-item questionnaire

Secondary outcomes

  1. Voice-Related Quality of Life

    Time frame: Change from baseline scores at 30 weeks

    Validated 10-item questionnaire

  2. Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores

    Time frame: Change from baseline scores at 30 weeks

    Validated Parkinson disease motor assessment scale

  3. Montreal Cognitive Assessment

    Time frame: Change from baseline scores at 30 weeks

    Validated cognitive assessment

  4. Geriatric Depression Scale-15

    Time frame: Change from baseline scores at 30 weeks

    Validated depression self-rating

  5. Lorig Self-efficacy scale

    Time frame: Change from baseline scores at 30 weeks

    5-item self-reported questionnaire

  6. Short Form-36

    Time frame: Change from baseline scores at 30 weeks

    Self-reported questionnaire assessing patients' health based on their physical and mental well-being

  7. Sound pressure level (decibels)

    Time frame: 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).

  8. Voice jitter

    Time frame: 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.

  9. Voice shimmer

    Time frame: 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.

  10. Harmonic to noise ratio

    Time frame: 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.

Other outcomes

  1. Feasibility

    Time frame: 12 weeks

    At least 80% of participants attending at least 9 of 12 singing classes and the final performance

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Acronym: Parkinsonics

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2016
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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