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Completed

NCT Number: NCT04569981

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna, Department of Neurology

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Climbing

Other

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

Other

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.

Primary outcomes

  1. Clinical Rating

    Time frame: 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

Secondary outcomes

  1. Change in Gait and Balance using wearable sensors

    Time frame: Testpoints: Change after 12 weeks of the intervention

    Inertial Sensors will be used to quantify gait metrics (postural sway, gait cycle, speed) as participants conduct walking and balance trials

  2. Quantified Bradykinesia test

    Time frame: Testpoints: Change after 12 weeks of the intervention

    Changes in a quantified bradykinesia Tests by using a standardized speeded keyboard tapping task. Changes will be evaluates in keys/second

  3. Hand grip strength

    Time frame: Testpoints: Change after 12 weeks of the intervention

    Assessment of hand grip strength, using a dynamometer. Results will be evaluated in Kilogramms

  4. Parkinson Quality of Life Questionaire-39 (PDQ-39)

    Time frame: Testpoints: Change after 12 weeks of the intervention

    Quality of life, assessed by the PDQ-39 Questionnaire

  5. Social Outcomes

    Time frame: Testpoints: Change after 12 weeks of the intervention

    Questionnaiers about social effects

  6. Cognitive assessments

    Time frame: Testpoints: Change after 12 weeks of the intervention

    Change in cognition will be assessed using a standardized cognitive assessment battery, measuring following domains: executive functions, memory, attention and verbal functions

  7. Changes in brain functional and structural MRI (resting state paradigma) and Changes in brain structural and functional MRI

    Time frame: Testpoints: Change after 12 weeks of the intervention

    Changes in structural and functional MRI (resting state paradigma) will be assessed

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • University Hospital Schleswig-Holstein
  • University of Vienna

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2020
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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