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Sport Climbing With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Climbing
Unsupervised activity group
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, sport climbing, motor symptoms, training therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Medical University of Vienna, Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Climbing Group (CG)

Unsupervised active group (UAG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical Rating
Motor Part of the Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) III

Secondary Outcome Measures

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
Quantified Bradykinesia test
Changes in a quantified bradykinesia Tests by using a standardized speeded keyboard tapping task. Changes will be evaluates in keys/second
Hand grip strength
Assessment of hand grip strength, using a dynamometer. Results will be evaluated in Kilogramms
Parkinson Quality of Life Questionaire-39 (PDQ-39)
Quality of life, assessed by the PDQ-39 Questionnaire
Social Outcomes
Questionnaiers about social effects
Cognitive assessments
Change in cognition will be assessed using a standardized cognitive assessment battery, measuring following domains: executive functions, memory, attention and verbal functions
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

Full Information

First Posted
August 17, 2020
Last Updated
September 27, 2020
Sponsor
Medical University of Vienna
Collaborators
University of Vienna, University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT04569981
Brief Title
Sport Climbing With Parkinson's Disease
Official Title
Climb up, Heads up: Sport Climbing With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
July 29, 2019 (Actual)
Study Completion Date
July 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
University of Vienna, University Hospital Schleswig-Holstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, sport climbing, motor symptoms, training therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants were randomly assigned to either the climbng group or the unsupervised active group
Masking
Care Provider
Masking Description
Movement disorder specialists who performed the MDS-UPDRS III ratings were blinded to the group assignment.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Idiopathic Parkinson's disease HY stage 1-3 Exclusion Criteria: cognitive impairment severe hearing or visual impairment severe orthopedic problems
Facility Information:
Facility Name
Medical University of Vienna, Department of Neurology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Sport Climbing With Parkinson's Disease

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