Back to resultsCycling Dual-task in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cycling exercise
Cognitive tasks
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Parkinson disease
- Hoehn and Yahr 1 and 2
Exclusion Criteria:
- Hoehn and Yahr >2
Sites / Locations
- University of Vigo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cycling combined with cognitive tasks
Cycling
Arm Description
Outcomes
Primary Outcome Measures
Timed Up and Go
Dynamic balance
Sit to Stand test
Lower limbs strength
Movement Disorder Society - Unified Parkinson's Disease Rating Scale
Parkinson's Disease rating
Parkinson's Disease Questionnaire - 39
Quality of life
Secondary Outcome Measures
Trail Making Test A & B
Attention, visual screening ability and processing speed
Stroop test
Ability to inhibit cognitive interference
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05184608
Brief Title
Cycling Dual-task in Parkinson's Disease
Official Title
Effects of a Cycling Dual-task Intervention on Cognition and Functionality in Parkinson's Disease: a Pilot Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
October 28, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vigo
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
Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cycling combined with cognitive tasks
Arm Type
Experimental
Arm Title
Cycling
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Cycling exercise
Intervention Description
20 minutes of cycling (90 rpm).
Intervention Type
Other
Intervention Name(s)
Cognitive tasks
Intervention Description
20 minutes of cognitive tasks based on the different domains of the UPDRS scale.
Primary Outcome Measure Information:
Title
Timed Up and Go
Description
Dynamic balance
Time Frame
Change from Baseline Timed Up and Go at 7 weeks
Title
Sit to Stand test
Description
Lower limbs strength
Time Frame
Change from Baseline Sit to Stan Test at 7 weeks
Title
Movement Disorder Society - Unified Parkinson's Disease Rating Scale
Description
Parkinson's Disease rating
Time Frame
Change from Baseline Unified Parkinson's Disease Rating Scale at 7 weeks (0-159, better lower values)
Title
Parkinson's Disease Questionnaire - 39
Description
Quality of life
Time Frame
Change from Baseline Parkinson's Disease Questionnaire - 39 at 7 weeks (0-100, better lower values)
Secondary Outcome Measure Information:
Title
Trail Making Test A & B
Description
Attention, visual screening ability and processing speed
Time Frame
Change from Baseline Trail Making Test A & B at 7 weeks
Title
Stroop test
Description
Ability to inhibit cognitive interference
Time Frame
Change from Baseline Stroop Test at 7 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson disease
Hoehn and Yahr 1 and 2
Exclusion Criteria:
Hoehn and Yahr >2
Facility Information:
Facility Name
University of Vigo
City
Pontevedra
ZIP/Postal Code
36004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Cycling Dual-task in Parkinson's Disease
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