Effects of Cycling Dual-task in Parkinson's Disease.
Sponsor
University of Vigo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05565300
Collaborator
(none)
44
1
2
8.5
5.2
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of a Forced Cycling Program With Cognitive Stimulation on Symptomatology, Physical Condition, and Cognition in People Diagnosed With Parkinson's Disease.
Actual Study Start Date
:
Sep 15, 2022
Anticipated Primary Completion Date
:
Apr 1, 2023
Anticipated Study Completion Date
:
Jun 1, 2023
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cycling combined with cognitive tasks
|
Other: Cycling exercise
30 minutes of cycling (90 rpm).
Other: Cognitive tasks
30 minutes of cognitive tasks based on the different domains of the Mini Mental Scale.
|
Active Comparator: Cycling
|
Other: Cycling exercise
30 minutes of cycling (90 rpm).
|
Outcome Measures
Primary Outcome Measures
- Timed Up and Go [Change from Baseline Timed Up and Go at 12 weeks]
Dynamic balance
- Sit to Stand test [Change from Baseline Sit to Stand Test at 12 weeks]
Lower limbs strength
- Movement Disorder Society - Unified Parkinson's Disease Rating Scale [Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks (0-159, better lower values)]
Parkinson's Disease rating
- Parkinson's Disease Questionnaire - 39 [Change from Baseline Parkinson's Disease Questionnaire - 39 at 12 weeks (0-100, better lower values)]
Quality of life
Secondary Outcome Measures
- Trail Making Test A & B [Change from Baseline Trail Making Test A & B at 12 weeks]
Attention, visual screening ability and processing speed
- Stroop test [Change from Baseline Stroop Test at 12 weeks]
Ability to inhibit cognitive interference
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Parkinson disease
-
Hoehn and Yahr 1 and 2
Exclusion Criteria:
- Hoehn and Yahr >2
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Vigo | Pontevedra | Spain | 36005 |
Sponsors and Collaborators
- University of Vigo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Iris Machado de Oliveira,
Principal Investigator,
University of Vigo
ClinicalTrials.gov Identifier:
NCT05565300
Other Study ID Numbers:
- 205-2022-2/2nd
First Posted:
Oct 4, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: