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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05375032
Other study ID # 205-2022-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2022
Est. completion date December 15, 2022

Study information

Verified date May 2023
Source University of Vigo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 15, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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).

Locations

Country Name City State
Spain University of Vigo Pontevedra

Sponsors (1)

Lead Sponsor Collaborator
University of Vigo

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Active Distance (m) Cycling active distance in meters. During the unique session
Other Passive Distance (m) Cycling assisted distance in meters. During the unique session
Other Total Work (W) Cycling total work developed in Watts During the unique session
Other Active Speed (rpm) Average cycling active speed in rotation per minute During the unique session
Other Passive Speed (rpm) Average cycling assisted speed in rotation per minute During the unique session
Other Symmetry (%) Percentage of the active work developed by each lower limb, right and left. During the unique session
Primary Change from baseline Heart Rate at 30 minutes Heart rate Pre and up to 30 minutes.
Primary Change from baseline Symbol Digit Modalities Test at 30 minutes Detection of cognitive dysfuntions. Pre and up to 30 minutes.
Secondary 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.
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