Parkinson DiseaseNCT05184608
Cycling Dual-task in Parkinson's Disease
A study testing Cycling exercise and Cognitive tasks 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 evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cycling exercise and Cognitive tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 11 Oct 2021to 31 Jan 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
- Parkinson disease
- Hoehn and Yahr 1 and 2
Who cannot join
- Hoehn and Yahr >2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Cycling Dual-task Intervention on Cognition and Functionality in Parkinson's Disease: a Pilot Randomized Clinical Trial
Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.
- Conditions
- Parkinson Disease
- Being tested
- Cycling exercise, Cognitive tasks
- 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 exerciseOther
20 minutes of cycling (90 rpm).
Cognitive tasksOther
20 minutes of cognitive tasks based on the different domains of the UPDRS scale.
| Study group | Role | What they receive |
|---|---|---|
| Cycling combined with cognitive tasks | Experimental | Not described Receives: Other: Cycling exercise; Other: Cognitive tasks |
| Cycling | Active comparator | Not described Receives: Other: Cycling exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go
Dynamic balance
Measured: Change from Baseline Timed Up and Go at 7 weeks
Sit to Stand test
Lower limbs strength
Measured: Change from Baseline Sit to Stan Test at 7 weeks
Movement Disorder Society - Unified Parkinson's Disease Rating Scale
Parkinson's Disease rating
Measured: Change from Baseline Unified Parkinson's Disease Rating Scale at 7 weeks (0-159, better lower values)
Parkinson's Disease Questionnaire - 39
Quality of life
Measured: Change from Baseline Parkinson's Disease Questionnaire - 39 at 7 weeks (0-100, better lower values)
Secondary outcomes (2)
Trail Making Test A & B
Attention, visual screening ability and processing speed
Measured: Change from Baseline Trail Making Test A & B at 7 weeks
Stroop test
Ability to inhibit cognitive interference
Measured: Change from Baseline Stroop Test at 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start11 Oct 2021
- Primary completion28 Oct 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 15 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
- NCT05184608
- Sponsor's protocol ID
- 2020/057
- Status last verified
- May 2022
- First submitted
- 26 Nov 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Cycling Dual-task Intervention on Cognition and Functionality in Parkinson's Disease: a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05184608
- Acronym / sponsor ID
- 2020/057
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 11 Jan 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 evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.
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 exercise, Other: Cognitive tasks |
| Cycling | Active comparator | Other: Cycling exercise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson disease
- Hoehn and Yahr 1 and 2
Key exclusion criteria (1 listed)
- Hoehn and Yahr >2
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 exercise20 minutes of cycling (90 rpm). | Other | Cycling, Cycling combined with cognitive tasks |
| Cognitive tasks20 minutes of cognitive tasks based on the different domains of the UPDRS scale. | Other | Cycling combined with cognitive tasks |
Primary outcome
Timed Up and Go
Time frame: Change from Baseline Timed Up and Go at 7 weeks
Dynamic balance
Sit to Stand test
Time frame: Change from Baseline Sit to Stan Test at 7 weeks
Lower limbs strength
Movement Disorder Society - Unified Parkinson's Disease Rating Scale
Time frame: Change from Baseline Unified Parkinson's Disease Rating Scale at 7 weeks (0-159, better lower values)
Parkinson's Disease rating
Parkinson's Disease Questionnaire - 39
Time frame: Change from Baseline Parkinson's Disease Questionnaire - 39 at 7 weeks (0-100, better lower values)
Quality of life
2 secondary outcomes
Trail Making Test A & B
Time frame: Change from Baseline Trail Making Test A & B at 7 weeks
Stroop test
Time frame: Change from Baseline Stroop Test at 7 weeks
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 25 May 2022.
- 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 exercise and Cognitive tasks 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 2 inclusion and 1 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 25 May 2022. 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?
Timed Up and Go (time frame: Change from Baseline Timed Up and Go at 7 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2022.