Sport Climbing With Parkinson's Disease

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

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Climbing; Other: Unsupervised activity group

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna, Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Climbing Group (CG); 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.	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.
Active Comparator: Unsupervised active group (UAG); 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Social Outcomes	Questionnaiers about social effects	Testpoints: Change after 12 weeks of the intervention
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
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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: University of Vienna; University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2018
• Primary Completion (Actual): July 29, 2019
• Study Completion (Actual): July 29, 2019

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: September 27, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 27, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson's disease; motor symptoms; sport climbing; training therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 1369/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No