Sport Climbing With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Climb up, Heads up: Sport Climbing With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04569981
• Other study ID #: 1369/2017
• Status: Completed
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: July 29, 2019

Study information

• Verified date: September 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 29, 2019
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Idiopathic Parkinson's disease

• HY stage 1-3

Exclusion Criteria:

• cognitive impairment

• severe hearing or visual impairment

• severe orthopedic problems

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Climbing
The patients in the Climbing Group (CG) followed a 12-weeks long climbing trainings course in small groups of 3-4 participants with a certified climbing instructor.
• Unsupervised activity group
The patients in the unsupervised activity group (UAG) received education European physiotherapy guidelines for physical activity recommended by the WHO of recommended activity and followed their self-selected activities over 12 weeks.

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Neurology	Vienna

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Vienna	University of Schleswig-Holstein, University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Rating	Motor Part of the Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) III	Testpoints: Change from Baseline Score after 12 weeks of the intervention
Secondary	Change in Gait and Balance using wearable sensors	Inertial Sensors will be used to quantify gait metrics (postural sway, gait cycle, speed) as participants conduct walking and balance trials	Testpoints: Change after 12 weeks of the intervention
Secondary	Quantified Bradykinesia test	Changes in a quantified bradykinesia Tests by using a standardized speeded keyboard tapping task. Changes will be evaluates in keys/second	Testpoints: Change after 12 weeks of the intervention
Secondary	Hand grip strength	Assessment of hand grip strength, using a dynamometer. Results will be evaluated in Kilogramms	Testpoints: Change after 12 weeks of the intervention
Secondary	Parkinson Quality of Life Questionaire-39 (PDQ-39)	Quality of life, assessed by the PDQ-39 Questionnaire	Testpoints: Change after 12 weeks of the intervention
Secondary	Social Outcomes	Questionnaiers about social effects	Testpoints: Change after 12 weeks of the intervention
Secondary	Cognitive assessments	Change in cognition will be assessed using a standardized cognitive assessment battery, measuring following domains: executive functions, memory, attention and verbal functions	Testpoints: Change after 12 weeks of the intervention
Secondary	Changes in brain functional and structural MRI (resting state paradigma) and Changes in brain structural and functional MRI	Changes in structural and functional MRI (resting state paradigma) will be assessed	Testpoints: Change after 12 weeks of the intervention