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Completed

NCT Number: NCT05375032

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vigo

Pontevedra, 36004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cycling dual task

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).

Primary outcomes

  1. Change from baseline Symbol Digit Modalities Test at 30 minutes

    Time frame: Pre and up to 30 minutes.

    Detection of cognitive dysfuntions.

  2. Mini-Mental State Examination (MMSE)

    Time frame: Pre

    To detect and estimate cognitive decline and dementia.

Secondary outcomes

  1. Borg Rated Perceived Exertion Scale

    Time frame: Up to 30 minutes.

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

  2. Change from baseline Heart Rate at 30 minutes

    Time frame: Pre and up to 30 minutes

    Heart rate

Other outcomes

  1. Active Distance (m)

    Time frame: During the unique session

    Cycling active distance in meters.

  2. Passive Distance (m)

    Time frame: During the unique session

    Cycling assisted distance in meters.

  3. Total Work (W)

    Time frame: During the unique session

    Cycling total work developed in Watts

  4. Active Speed (rpm)

    Time frame: During the unique session

    Average cycling active speed in rotation per minute

  5. Passive Speed (rpm)

    Time frame: During the unique session

    Average cycling assisted speed in rotation per minute

  6. Symmetry (%)

    Time frame: During the unique session

    Percentage of the active work developed by each lower limb, right and left.

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 16, 2022
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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