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临床试验/NCT05379062
NCT05379062Unknown不适用

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

University of Salzburg4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
4
主要终点
Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post music interventions over 12 weeks

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with Parkinson's disease 1-4 according to Hoehn-Yahr Scale
  • Signed consent to participate in the study

排除标准

  • Morbus Parkinson 5 according to Hoehn-Yahr Scale
  • 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

结局指标

主要结局

Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post music interventions over 12 weeks

时间窗: 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

Biological Stress Marker: Salivary Alpha-Amylase

Change from Baseline Anxiety and Depression at 6 and 12 weeks

时间窗: 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

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

Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post music interventions over 12 weeks

时间窗: 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

Biological Stress Marker: Salivary Cortisol

次要结局

  • Consumption of medication(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(12 weeks; outcomes will be measured at the beginning of the study and at the end of the study after 12 weeks)
  • Mood(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(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(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)(12 weeks; outcomes will be measured weekly pre singing intervention)
  • Life Quality(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)
  • Evaluation of the intervention(12 weeks; outcomes will be measured weekly post singing and music listening sessions)

研究者

发起方
University of Salzburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Katarzyna Grebosz-Haring

Principal Investigator

University of Salzburg

研究点 (4)

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