Parkinson DiseaseNCT05375032
Acute Effects of Cycling Dual-task in Parkinson´s Disease.
A study testing Cycling combined with cognitive tasks and Cycling in people with Parkinson Disease, run by University of Vigo at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cycling combined with cognitive tasks and Cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 13 May 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease
- Present stage between I and III on the Hoenh and Yarh scale
- Being able to move autonomously
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Cycling combined with cognitive tasks, Cycling
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling combined with cognitive tasksOther
Also called Cycling dual task
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.
CyclingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Cycling combined with cognitive tasks | Experimental | Not described Receives: Other: Cycling combined with cognitive tasks |
| Cycling | Active comparator | Not described Receives: Other: Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Symbol Digit Modalities Test at 30 minutes
Detection of cognitive dysfuntions.
Measured: Pre and up to 30 minutes.
Mini-Mental State Examination (MMSE)
To detect and estimate cognitive decline and dementia.
Measured: Pre
Secondary outcomes (2)
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.
Measured: Up to 30 minutes.
Change from baseline Heart Rate at 30 minutes
Heart rate
Measured: Pre and up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start13 May 2022
- Primary completion31 Jul 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iris Machado de Oliveira, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375032
- Sponsor's protocol ID
- 205-2022-2
- Status last verified
- Mar 2025
- First submitted
- 2 May 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mollinedo-Cardalda I, Monge-Pereira E, Pereira-Pedro KP, Machado de Oliveira I. Acute effects of an aerobic dual task on processing speed and attention in Parkinson's disease: a randomised controlled trial study. J Bodyw Mov Ther. 2025 Dec;45:1074-1081. doi: 10.1016/j.jbmt.2025.10.043. Epub 2025 Nov 3.
PubMed 41316559
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Cycling Dual-task on Cognitive and Physical Function in Parkinson´s Disease: a Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT05375032
- Acronym / sponsor ID
- 205-2022-2
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycling combined with cognitive tasks | Experimental | Other: Cycling combined with cognitive tasks |
| Cycling | Active comparator | Other: Cycling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Parkinson's disease
- Present stage between I and III on the Hoenh and Yarh scale
- Being able to move autonomously
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling combined with cognitive tasksAlso: Cycling dual taskA 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 | Cycling combined with cognitive tasks |
| CyclingA 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). | Other | Cycling |
Primary outcome
Change from baseline Symbol Digit Modalities Test at 30 minutes
Time frame: Pre and up to 30 minutes.
Detection of cognitive dysfuntions.
Mini-Mental State Examination (MMSE)
Time frame: Pre
To detect and estimate cognitive decline and dementia.
2 secondary outcomes
Borg Rated Perceived Exertion Scale
Time frame: Up to 30 minutes.
Change from baseline Heart Rate at 30 minutes
Time frame: Pre and up to 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 41316559Mollinedo-Cardalda I, Monge-Pereira E, Pereira-Pedro KP, Machado de Oliveira I. Acute effects of an aerobic dual task on processing speed and attention in Parkinson's disease: a randomised controlled trial study. J Bodyw Mov Ther. 2025 Dec;45:1074-1081. doi: 10.1016/j.jbmt.2025.10.043. Epub 2025 Nov 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling combined with cognitive tasks and Cycling in people with Parkinson Disease, run by University of Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Symbol Digit Modalities Test at 30 minutes (time frame: Pre and up to 30 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05375032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.