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

Acute Effects of Cycling Dual-task on Cognitive and Physical Function in Parkinson´s Disease: a Cross-sectional Study.

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Cycling combined with cognitive tasks; Other: Cycling

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iris M de Oliveira, Ph.D.; Phone Number: 034986801768; Email: irismacoli@uvigo.es

Study Locations

• Spain
  • Pontevedra, Spain, 36004
    • University of Vigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cycling combined with cognitive tasks	Other: Cycling combined with cognitive tasks; 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.; Other Names: Cycling dual task
Active Comparator: Cycling	Other: Cycling; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Heart Rate at 30 minutes	Heart rate	Pre and up to 30 minutes.
Change from baseline Symbol Digit Modalities Test at 30 minutes	Detection of cognitive dysfuntions.	Pre and up to 30 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 30 minutes.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Distance (m)	Cycling active distance in meters.	During the unique session
Passive Distance (m)	Cycling assisted distance in meters.	During the unique session
Total Work (W)	Cycling total work developed in Watts	During the unique session
Active Speed (rpm)	Average cycling active speed in rotation per minute	During the unique session
Passive Speed (rpm)	Average cycling assisted speed in rotation per minute	During the unique session
Symmetry (%)	Percentage of the active work developed by each lower limb, right and left.	During the unique session

Collaborators and Investigators

• Sponsor: University of Vigo

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 205-2022-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No