Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sport Climbing With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04569981
Recruitment Status : Completed
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Collaborators:
University of Vienna
University Hospital Schleswig-Holstein
Information provided by (Responsible Party):
Heidemarie Zach, MD, BSc., Medical University of Vienna

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Climbing Other: Unsupervised activity group Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants were randomly assigned to either the climbng group or the unsupervised active group
Masking: Single (Care Provider)
Masking Description: Movement disorder specialists who performed the MDS-UPDRS III ratings were blinded to the group assignment.
Primary Purpose: Treatment
Official Title: Climb up, Heads up: Sport Climbing With Parkinson's Disease
Actual Study Start Date : June 5, 2018
Actual Primary Completion Date : July 29, 2019
Actual Study Completion Date : July 29, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • cognitive impairment
  • severe hearing or visual impairment
  • severe orthopedic problems
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569981


Locations
Layout table for location information
Austria
Medical University of Vienna, Department of Neurology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
University of Vienna
University Hospital Schleswig-Holstein
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Heidemarie Zach, MD, BSc., Principal Inversigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04569981    
Other Study ID Numbers: 1369/2017
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heidemarie Zach, MD, BSc., Medical University of Vienna:
Parkinson's disease
sport climbing
motor symptoms
training therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases