Sport Climbing With Parkinson's Disease

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT04569981
Collaborator
University of Vienna (Other), University Hospital Schleswig-Holstein (Other)
48
1
2
13.8
3.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Climbing
  • Other: Unsupervised activity group
N/A

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

Study Type:
Interventional
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 groupThe 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 :
Jun 5, 2018
Actual Primary Completion Date :
Jul 29, 2019
Actual Study Completion Date :
Jul 29, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. Clinical Rating [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 [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 [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 [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) [Testpoints: Change after 12 weeks of the intervention]

    Quality of life, assessed by the PDQ-39 Questionnaire

  5. Social Outcomes [Testpoints: Change after 12 weeks of the intervention]

    Questionnaiers about social effects

  6. Cognitive assessments [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 [Testpoints: Change after 12 weeks of the intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Medical University of Vienna, Department of Neurology Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna
  • University of Vienna
  • University Hospital Schleswig-Holstein

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heidemarie Zach, MD, BSc., Principal Inversigator, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04569981
Other Study ID Numbers:
  • 1369/2017
First Posted:
Sep 30, 2020
Last Update Posted:
Sep 30, 2020
Last Verified:
Sep 1, 2020
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., Principal Inversigator, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2020