Mild Cognitive ImpairmentNCT05172661
Effects of Physical-Cognitive Training With Different Task Models in Parkinson's Disease With Mild Cognitive Impairment
A study testing Integrated physical-cognitive training and Consecutive physical-cognitive training in people with Mild Cognitive Impairment and Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The present study will characterize exercise model effects (integrated model vs. consecutive model) of physical-cognitive exercise on dual-task walking control in Parkinson's disease with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Parkinson Disease
- What is being tested?
- Integrated physical-cognitive training and Consecutive physical-cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Nov 2021to 30 Sep 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of idiopathic Parkinson's disease
- have decreased cognitive functions but do not interfere with functional independence
- Montreal Cognitive Assessment (MoCA): 21-25
- able to walk independently without walking devices for at least 10 meters and with the ability to turn 180°
Who cannot join
- a diagnosis of dementia
- other diseases that may influence cognitive functions or walking performance
- a history of brain surgery
- modification of the medication during the exercise intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical-Cognitive Training With Different Task Models on Dual-Task Walking in Parkinson's Disease With Mild Cognitive Impairment
The present study will characterize exercise model effects (integrated model vs. consecutive model) of physical-cognitive exercise on dual-task walking control in Parkinson's disease with mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment, Parkinson Disease
- Being tested
- Integrated physical-cognitive training, Consecutive physical-cognitive training
- Keywords
- Dual-task walking training, Parkinson's disease, Mild cognitive impairment, Electroencephalography
- Medical subject headings
- Cognitive Dysfunction, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated physical-cognitive trainingBehavioural
Perform a postural task and a cognitive task at the same time (dual-task model) 70 minutes/session*2 sessions/week*6 weeks
Consecutive physical-cognitive trainingBehavioural
Perform a postural task and a cognitive task separately for identical durations 70 minutes/session*2 sessions/week*6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Integrated training model | Experimental | Participants in this group will accept postural and cognitive training at the same time, e.g. naming animals while standing on the foam.
Each training session will last for 70 minutes, twice a week, and 12 sessions in total. Receives: Behavioral: Integrated physical-cognitive training |
| Consecutive training model | Experimental | Participants in this group will accept postural and cognitive training separately and for identical durations (both 30 minutes).
Each training session will last for 70 minutes, twice a week, and 12 sessions in total. Receives: Behavioral: Consecutive physical-cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline dual-task walking performance at 8 weeks
Measured: 8 weeks
Fall frequency
Measured: 20 weeks
Change from baseline Montreal Cognitive Assessment (MoCA) score at 8 weeks
MoCA: 0-30 points, higher scores mean a better outcome
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start26 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172661
- Sponsor's protocol ID
- 202109095RINA
- Status last verified
- Jan 2023
- First submitted
- 29 Nov 2021
- Last updated
- 2 Feb 2023
- Results posted
- 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 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical-Cognitive Training With Different Task Models on Dual-Task Walking in Parkinson's Disease With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05172661
- Acronym / sponsor ID
- 202109095RINA
- Conditions
- Mild Cognitive Impairment, Parkinson Disease
- Keywords
- Dual-task walking training, Parkinson's disease, Mild cognitive impairment, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 29 Dec 2021 (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.
The present study will characterize exercise model effects (integrated model vs. consecutive model) of physical-cognitive exercise on dual-task walking control in Parkinson's disease with mild cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated training model | Experimental | Behavioral: Integrated physical-cognitive trainingParticipants in this group will accept postural and cognitive training at the same time, e.g. naming animals while standing on the foam. Each training session will last for 70 minutes, twice a week, and 12 sessions in total. |
| Consecutive training model | Experimental | Behavioral: Consecutive physical-cognitive trainingParticipants in this group will accept postural and cognitive training separately and for identical durations (both 30 minutes). Each training session will last for 70 minutes, twice a week, and 12 sessions in total. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of idiopathic Parkinson's disease
- have decreased cognitive functions but do not interfere with functional independence
- Montreal Cognitive Assessment (MoCA): 21-25
- able to walk independently without walking devices for at least 10 meters and with the ability to turn 180°
Key exclusion criteria (4 listed)
- a diagnosis of dementia
- other diseases that may influence cognitive functions or walking performance
- a history of brain surgery
- modification of the medication during the exercise intervention
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 |
|---|---|---|
| Integrated physical-cognitive trainingPerform a postural task and a cognitive task at the same time (dual-task model) 70 minutes/session*2 sessions/week*6 weeks | Behavioural | Integrated training model |
| Consecutive physical-cognitive trainingPerform a postural task and a cognitive task separately for identical durations 70 minutes/session*2 sessions/week*6 weeks | Behavioural | Consecutive training model |
Primary outcome
Change from baseline dual-task walking performance at 8 weeks
Time frame: 8 weeks
Fall frequency
Time frame: 20 weeks
Change from baseline Montreal Cognitive Assessment (MoCA) score at 8 weeks
Time frame: 8 weeks
MoCA: 0-30 points, higher scores mean a better outcome
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 Feb 2023.
- 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 Integrated physical-cognitive training and Consecutive physical-cognitive training in people with Mild Cognitive Impairment and Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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 Feb 2023. 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 Taiwan. 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 dual-task walking performance at 8 weeks (time frame: 8 weeks). The study lists 3 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 2 Feb 2023.