NCT04569981

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

August 17, 2020

Last Update Submit

September 27, 2020

Conditions

Parkinson Disease

Keywords

Parkinson's diseasesport climbingmotor symptomstraining therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in Gait and Balance using wearable sensors

    Testpoints: Change after 12 weeks of the intervention

  • Quantified Bradykinesia test

    Testpoints: Change after 12 weeks of the intervention

  • Hand grip strength

    Testpoints: Change after 12 weeks of the intervention

  • Parkinson Quality of Life Questionaire-39 (PDQ-39)

    Testpoints: Change after 12 weeks of the intervention

  • Social Outcomes

    Testpoints: Change after 12 weeks of the intervention

  • +2 more secondary outcomes

Study Arms (2)

Climbing Group (CG)

ACTIVE COMPARATOR

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

Unsupervised active group (UAG)

ACTIVE COMPARATOR

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

Interventions

ClimbingOTHER

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.

Climbing Group (CG)
Unsupervised activity groupOTHER

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.

Unsupervised active group (UAG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Neurology

Vienna, 1090, Austria

Location

Related Publications (1)

  • Langer A, Hansen C, Roth D, Santer A, Flotz A, Gruber J, Wizany L, Hasenauer S, Pokan R, Dabnichki P, Treven M, Zimmel S, Schmoeger M, Willinger U, Gassner L, Brucke C, Maetzler W, Zach H. Vertical locomotion improves horizontal locomotion: effects of climbing on gait and other mobility aspects in Parkinson's disease. A secondary analysis from a randomized controlled trial. J Neuroeng Rehabil. 2024 Apr 27;21(1):63. doi: 10.1186/s12984-024-01363-4.

    PMID: 38678241DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Stair Climbing

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

WalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Movement disorder specialists who performed the MDS-UPDRS III ratings were blinded to the group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The participants were randomly assigned to either the climbng group or the unsupervised active group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Inversigator

Study Record Dates

First Submitted

August 17, 2020

First Posted

September 30, 2020

Study Start

June 5, 2018

Primary Completion

July 29, 2019

Study Completion

July 29, 2019

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations

AU(1)