Choral Singing for Patients With Parkinson's

Study Overview
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Brief Summary
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Study Design: Multi-centered, open, prospective, three-arm, randomized, controlled parallel-group study; Study Participants: Adult patients with Parkinson's disease in Salzburg (and surroundings) and Vienna (and surroundings); Planned Sample Size: Experimental Group 1 (singing in a group/active): 30 persons; Experimental group 2 (receptive music/auditive): 30 persons; Control group (treatment as usual condition): 30 persons; Planned Duration of Study: Recruitment: spring 2022, study duration: spring 2022 to autumn 2022, evaluation phase and publication: autumn-summer 2022/2023; Primary Objectives: Reduction of depression, anxiety and physiological stress; Measurement of the Endpoints: Hospital Anxiety and Depression Scale - German Version (HADS-D), Biochemical determination: cortisol and alpha-amylase (concentration measurement in saliva).

Detailed Description
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Parkinson's disease is predominantly a disease of old age. A total of about 16,000 patients suffer from Parkinson's disease in Austria. This corresponds to about 0.1% of the population over 50 years of age. In addition to motor and language deficits, psychological deficits also occur. These are usually found between the ages of 50 and 60. The lack of dopamine is the main basis of modern Parkinson therapy. The physiological part of Parkinson's disease can today be well-controlled with medication. Significantly better results can only be achieved with accompanying music-related interventions. For example, regular group singing under professional guidance seems advantageous. The music-induced, rhythmic movement associated with singing, the active posture, the more differentiated strain on the vocal apparatus and breathing compared to speaking, and last but not least, the predominantly positive affectivity show that singing is a complex, ecologically valid form of interpersonal interaction that is also effective on a psychosocial level. In short, many of the therapeutic goals relevant to people with Parkinson's disease are likely to be better achieved through this group activity. Singing together stimulates numerous physical systems as well as perception, attention and cognition. Synchronised movements have also been associated in various studies with increased pain tolerance and may be beneficial in maintaining motor performance in people with Parkinson's disease. Singing improves the immune defence of many patients according to further systematic observations. The results show clear improvements in various health indicators, also in a sustainable course. In addition, regular listening to specifically selected stimulating music, as compiled on a new CD (ISBN: 978-3-9502441-2-0) produced by the project submitter's research group, leads to increased blood flow to certain brain areas. Among other things, dopamine is released. In case of sudden blockages, the pointed rhythm of the Radetzky March, recorded on the CD, helps in a rapid way that could not be achieved with any medication in such a short time. The aim of this randomized study is to investigate the effect of group singing on the improvement of symptoms of Parkinson's disease, depression, anxiety and stress. Furthermore, the quality of life and the course of parkinson's disease will be assessed. It must also be clarified how often choral singing can be rehearsed in a meaningful way before a weakening (tolerance) of the effect occurs and how high the patients' compliance is. To objectify this study, three groups will be randomly assigned: group one receives the group singing intervention, group two the music listening intervention and group three as a control group (treatment as usual group) receives no musical activity. The results of the present study should be offered to the rehabilitation centres for support of Parkinson patients.

Official Title
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Singing in a Group Compared to Receptive Music and Treatment as a Usual Condition in Patients With Parkinson's Disease: A Randomized Controlled Trial to Develop Guidelines/Recommendations for Efficient Use

Conditions
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Parkinson

Intervention / Treatment
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* Behavioral: Active Singing Group
* Behavioral: Receptive Music Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with Parkinson's disease 1-4 according to Hoehn-Yahr Scale Signed consent to participate in the study Age >18 Exclusion Criteria: Morbus Parkinson 5 according to Hoehn-Yahr Scale Dementia Aversion to music (Amusia) Participation in other active music-based activities (e.g. choir singing, dancing, playing an instrument, making music, playing in an orchestra) during the study

Ages Eligible for Study
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Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group (singing in a group/active) Experimental group (receptive music/auditive) Control group (treatment as usual condition)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Singing Group<br>Active singing in a group | Behavioral: Active Singing Group<br>* The participants of the Active Singing Group take part in a weekly 45-minute singing activity in a group over a period of 3 months. In total the investigators expect 12 choir rehearsals. The rehearsals will take place between 2pm and 3.30pm in the church of the Wehrle-Diakonissen Private Clinic in Salzburg. The group will be led by a professional and experienced choir director.<br>|
| Experimental: Receptive Music Group<br>Receptive music/auditive group | Behavioral: Receptive Music Group<br>* The participants of the Receptive Music Group will individually listen to the already researched CD for Parkinson's patients (Bernatzky, Wendtner, Volc, 2012) at home at the same time on one weekday.<br>|
| No Intervention: Control Group<br>Treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Anxiety and Depression at 6 and 12 weeks | Hospital Anxiety and Depression Scale - German Version 2011, C. Herrmann-Lingen, U. Buss & R. P. Snaith. Minimum value 0, maximum value 21, higher score means a better outcome | 18 weeks; outcomes will be measured at the beginning of the study, after 6 weeks, at the end of the study after 12 weeks, and at a follow-up 6 weeks after the end of the study | 
| Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post music interventions over 12 weeks | Biological Stress Marker: Salivary Cortisol | 12 weeks; outcomes will be measured weekly immediately before and after each 45-minute session in the experimental groups. Outcomes in the control group will be measured twice every week at the same times, 45 minutes apart | 
| Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post music interventions over 12 weeks | Biological Stress Marker: Salivary Alpha-Amylase | 12 weeks; outcomes will be measured weekly immediately before and after each 45-minute session in the experimental groups. Outcomes in the control group will be measured twice every week at the same times, 45 minutes apart | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | Multidimensional Mood State Questionnaire, short version (1997), R. Steyer, P. Notz, P. Schwenkmezger & M. Eid. Higher score means a better outcome | 12 weeks; outcomes will be measured weekly immediately before and after each 45-minute session in the experimental groups. Outcomes in the control group will be measured twice every week at the same times, 45 minutes apart | 
| Stress Perception | Visual Analogue Scale. Minimum 0, Maximum 100, higher score means a worse outcome | 12 weeks; outcomes will be measured weekly immediately before and after each 45-minute session in the experimental groups. Outcomes in the control group will be measured twice every week at the same times, 45 minutes apart | 
| Chronic Stress | Perceived Stress Scale German version (2020), E.E. Schneider, S. Schönfelder, M. Domke-Wolf & M. Wessa. Higher score means a worse outcome | 18 weeks; outcomes will be measured at the beginning of the study, after 6 weeks, at the end of the study after 12 weeks, and at a follow-up 6 weeks after the end of the study | 
| Participation in meetings (compliance) | Self-developed compliance sheet for patients. Minimum 0, maximum 12. Higher score means a better outcome | 12 weeks; outcomes will be measured weekly pre singing intervention | 
| Life Quality | Parkinson's Disease Questionnaire German Version (2011), S. Schädler. Minimum 0, maximum 100, higher score means a worse outcome | 18 weeks; outcomes will be measured at the beginning of the study, after 6 weeks, at the end of the study after 12 weeks, and at a follow-up 6 weeks after the end of the study | 
| Consumption of medication | Sheet for patients, higher score means a worse outcome | 18 weeks; outcomes will be measured at the beginning of the study, after 6 weeks, at the end of the study after 12 weeks, and at a follow-up 6 weeks after the end of the study | 
| Parkinson development | Hoehn-Yahr scale (1967), M. M. Hoehn & M. D. Yahr (evaluation by the neurologist). Minimum value 1, maximum value 5, higher score means a worse outcome | 12 weeks; outcomes will be measured at the beginning of the study and at the end of the study after 12 weeks | 
| Evaluation of the intervention | Liking of the session, liking of the songs/music pieces, familiarity with the songs/music pieces (9-point Likert scale; higher score means a better outcome) | 12 weeks; outcomes will be measured weekly post singing and music listening sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson, Singing, Music, Stress, Cortisol, Depression