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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05375032
• Other study ID #: 205-2022-2
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Parkinson Disease

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.