Climb up, Heads up: Sport Climbing With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Clinical Rating
研究概览
简要总结
This controlled interventional study will investigate the effects of a 12-weeks sport climbing course compared to 24 weeks of unsupervised physical exercise on motor symptoms in Parkinson's disease
详细描述
The primary aim of this study is to evaluate the effects of a 12-week sport climbing course versus unsupervised physical exercise on motor symptoms in patients with Parkinson's disease.
Background: Sport climbing (SC) is known as a whole-body workout, which additionally trains cognitive, mental, and social abilities. In contrast to its public image, SC in a controlled environment using "top-rope" belay, is a safe sport and can be performed at any age and at any level. In the field of neurological rehabilitation, it is already used as "therapeutic SC" for other neurological diseases, such as stroke, multiple sclerosis, depressions etc. but studies on climbing in PD patients are lacking.
Hypothesis
to find significant improvement of motor symptoms in the climbing group compared to the control group as well as biopsychosocial improvements after 6 weeks, 12 weeks, and 6 months after the intervention.
Methods: Effects of SC on motor symptoms in 48 PD patients in total, who will be randomized into a climbing group (n=24) and a control group (n=24) will be evaluated. The climbing group will follow a 12-week 90 min/week climbing trainings course, led by professional climbing instructors.
The control group will receive education/information material of the European physiotherapy guidelines for physical activity recommended by the WHO and will be instructed to follow the recommendation of the guidelines to independently live an active lifestyle and train unsupervised. All patients will be evaluated with clinical assessments at baseline, in between the study period (mid), after completing the 12-weeks study period (post). As additional outcomes, health benefits of SC in PD with a holistic approach, covering biopsychosocial aspects will be investigated. Therefore, non-motoric and motoric parameters will be evaluated, and follow-up assessments 6 months after.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Movement disorder specialists who performed the MDS-UPDRS III ratings were blinded to the group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Idiopathic Parkinson's disease
- •HY stage 1-3
排除标准
- •cognitive impairment
- •severe hearing or visual impairment
- •severe orthopedic problems
结局指标
主要结局
Clinical Rating
时间窗: Testpoints: Change from Baseline Score after 12 weeks of the intervention
Motor Part of the Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) III
次要结局
- Change in Gait and Balance using wearable sensors(Testpoints: Change after 12 weeks of the intervention)
- Quantified Bradykinesia test(Testpoints: Change after 12 weeks of the intervention)
- Hand grip strength(Testpoints: Change after 12 weeks of the intervention)
- Parkinson Quality of Life Questionaire-39 (PDQ-39)(Testpoints: Change after 12 weeks of the intervention)
- Social Outcomes(Testpoints: Change after 12 weeks of the intervention)
- Cognitive assessments(Testpoints: Change after 12 weeks of the intervention)
- Changes in brain functional and structural MRI (resting state paradigma) and Changes in brain structural and functional MRI(Testpoints: Change after 12 weeks of the intervention)
研究者
Heidemarie Zach, MD, BSc.
Principal Inversigator
Medical University of Vienna