Clinical trial NCT04569981: Sport Climbing With Parkinson's Disease
Official title: Climb up, Heads up: Sport Climbing With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
sport climbing
motor symptoms
training therapy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University of Vienna
name: University Hospital Schleswig-Holstein
First posted: 2020-09-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were randomly assigned to either the climbng group or the unsupervised active group
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease
* HY stage 1-3

Exclusion Criteria:

* cognitive impairment
* severe hearing or visual impairment
* severe orthopedic problems

Primary outcomes:
measure: Clinical Rating
timeFrame: Testpoints: Change from Baseline Score after 12 weeks of the intervention
Secondary outcomes:
measure: Change in Gait and Balance using wearable sensors
timeFrame: Testpoints: Change after 12 weeks of the intervention
measure: Quantified Bradykinesia test
timeFrame: Testpoints: Change after 12 weeks of the intervention
measure: Hand grip strength
timeFrame: Testpoints: Change after 12 weeks of the intervention
measure: Parkinson Quality of Life Questionaire-39 (PDQ-39)
timeFrame: Testpoints: Change after 12 weeks of the intervention
measure: Social Outcomes
timeFrame: Testpoints: Change after 12 weeks of the intervention
measure: Cognitive assessments
timeFrame: Testpoints: Change after 12 weeks of the intervention
measure: Changes in brain functional and structural MRI (resting state paradigma) and Changes in brain structural and functional MRI
timeFrame: Testpoints: Change after 12 weeks of the intervention
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Neurology
Study officials:
References: