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

NCT05375032 | Completed

• 1 other identifier: 205-2022-2
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline Symbol Digit Modalities Test at 30 minutes

  Detection of cognitive dysfuntions.

  Pre and up to 30 minutes.

• Mini-Mental State Examination (MMSE)

  To detect and estimate cognitive decline and dementia.

  Pre

Secondary Outcomes (2)

• Borg Rated Perceived Exertion Scale

  Up to 30 minutes.

• Change from baseline Heart Rate at 30 minutes

  Pre and up to 30 minutes

Other Outcomes (6)

• Active Distance (m)

  During the unique session

• Passive Distance (m)

  During the unique session

• Total Work (W)

  During the unique session

Study Arms (2)

Cycling combined with cognitive tasks

EXPERIMENTAL

Other: Cycling combined with cognitive tasks

Cycling

ACTIVE COMPARATOR

Other: Cycling

Interventions

Cycling combined with cognitive tasks OTHER

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.

Also known as: Cycling dual task

Cycling combined with cognitive tasks

Cycling OTHER

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).

Cycling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vigo: lead

Study Sites (1)

University of Vigo

Pontevedra, Pontevedra, 36004, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 16, 2022
• Study Start: May 13, 2022
• Primary Completion: July 31, 2022
• Study Completion: December 15, 2022
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)