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Acute Effects of Cycling Dual-task in Parkinson´s Disease.

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cycling combined with cognitive tasks
Cycling
Sponsored by
University of Vigo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Idiopathic Parkinson's disease
  • Present stage between I and III on the Hoenh and Yarh scale
  • Being able to move autonomously

Exclusion Criteria:

  • Moderate-severe cognitive impairment (Mini-mental test > 24)
  • Comorbidity that discourages the practice of physical exercise and that allows performing all scheduled assessments
  • Severe visual alterations that prevent the development of the session

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

Change from baseline Heart Rate at 30 minutes
Heart rate
Change from baseline Symbol Digit Modalities Test at 30 minutes
Detection of cognitive dysfuntions.

Secondary Outcome Measures

Borg Rated Perceived Exertion Scale
Perceived exertion. These include a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort.

Full Information

First Posted
May 2, 2022
Last Updated
May 24, 2023
Sponsor
University of Vigo
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1. Study Identification

Unique Protocol Identification Number
NCT05375032
Brief Title
Acute Effects of Cycling Dual-task in Parkinson´s Disease.
Official Title
Acute Effects of Cycling Dual-task on Cognitive and Physical Function in Parkinson´s Disease: a Cross-sectional Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
December 15, 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 pathology, the objective of this study is to evaluate the acute effects of aerobic exercise in forced cycling performed with lower limbs and freecycling of upper limbs combined with cognitive stimuli on attention, exploration skills, and short-term motor skills in people with Parkinson's disease.

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
44 (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 combined with cognitive tasks
Other Intervention Name(s)
Cycling dual task
Intervention Description
A 30-minute session of Forced Cycling aerobic exercise performed with lower limbs and free active cycling performed with upper limbs combined with cognitive stimuli. An intelligent cycle ergometer (Motomed Viva 2 Parkinson) will be used, at a reserve heart rate of 55-70% (Borg scale 12-14) during the active part. The forced cycling program will consist of a 6-minute passive warm-up part (40-60 RPM), a 20-minute active part (90 RPM), and a 4-minute passive cool down (40 RPM). The cognitive task will be a PowerPoint presentation structured in a way that is consistent with the phases of the cycling program. The passive phases (6 minutes of warm-up and 4 minutes of passive cycling back to cool down), images of the nearby environment will be played. For the active phase (20 minutes of assisted active cycling) the PowerPoint presentation will be structured with tasks related to: orientation, memory, calculation, language, similarities.
Intervention Type
Other
Intervention Name(s)
Cycling
Intervention Description
A 30-minute session of Forced Cycling aerobic exercise performed with lower limbs and free active cycling performed with upper limbs combined with cognitive stimuli. An intelligent cycle ergometer (Motomed Viva 2 Parkinson) will be used, at a reserve heart rate of 55-70% (Borg scale 12-14) during the active part. The forced cycling program will consist of a 6-minute passive warm-up part (40-60 RPM), a 20-minute active part (90 RPM), and a 4-minute passive cool down (40 RPM).
Primary Outcome Measure Information:
Title
Change from baseline Heart Rate at 30 minutes
Description
Heart rate
Time Frame
Pre and up to 30 minutes.
Title
Change from baseline Symbol Digit Modalities Test at 30 minutes
Description
Detection of cognitive dysfuntions.
Time Frame
Pre and up to 30 minutes.
Secondary Outcome Measure Information:
Title
Borg Rated Perceived Exertion Scale
Description
Perceived exertion. These include a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort.
Time Frame
Up to 30 minutes.
Other Pre-specified Outcome Measures:
Title
Active Distance (m)
Description
Cycling active distance in meters.
Time Frame
During the unique session
Title
Passive Distance (m)
Description
Cycling assisted distance in meters.
Time Frame
During the unique session
Title
Total Work (W)
Description
Cycling total work developed in Watts
Time Frame
During the unique session
Title
Active Speed (rpm)
Description
Average cycling active speed in rotation per minute
Time Frame
During the unique session
Title
Passive Speed (rpm)
Description
Average cycling assisted speed in rotation per minute
Time Frame
During the unique session
Title
Symmetry (%)
Description
Percentage of the active work developed by each lower limb, right and left.
Time Frame
During the unique session

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic Parkinson's disease Present stage between I and III on the Hoenh and Yarh scale Being able to move autonomously Exclusion Criteria: Moderate-severe cognitive impairment (Mini-mental test > 24) Comorbidity that discourages the practice of physical exercise and that allows performing all scheduled assessments Severe visual alterations that prevent the development of the session
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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Acute Effects of Cycling Dual-task in Parkinson´s Disease.

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