Mild Cognitive Impairment (MCI)NCT06930742
Mindfulness-Enhanced Dual-Task Training in PD-MCI
A study testing Cognitive-Motor Dual-Task Training, Mindfulness Training and Single-task Training in people with Mild Cognitive Impairment (MCI) and Parkinson's Disease (PD), run by Nanjing Mingzhou Rehabilitation Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Mindfulness-Enhanced Dual-Task Training work to treat PD-MCI in adults. The main questions it aims to answer are: Does Mindfulness-Enhanced Dual-Task Training improve the cognitive or motor function of participants? Can the combination of Dual-Task Training and… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Parkinson's Disease (PD)
- What is being tested?
- Cognitive-Motor Dual-Task Training, Mindfulness Training and Single-task Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Between 55 and 75 years.
- Disease Diagnosis: Clinically diagnosed with Idiopathic Parkinson's Disease (PD) according to the UK Parkinson's Disease Society Brain Bank Criteria.
- Disease Stage: Hoehn \& Yahr (H\&Y) stages 1 to 2.5.
- Cognitive Function: Montreal Cognitive Assessment (MoCA) score between 23 and 26, indicating mild cognitive impairment (MCI).
- Medication Stability: Stable doses of antiparkinsonian medications for at least 4 weeks prior to screening.
- Subjective Cognitive Complaints: Self-reported or informant-reported cognitive decline persisting for at least 6 months.
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- Ambulatory Ability: Able to walk independently, with or without assistive devices.
- Sensory Abilities: Adequate vision and hearing to comply with study procedures.
- Informed Consent: Willingness to provide written informed consent and comply with study requirements.
Who cannot join
- Other Neurological Disorders: Presence of other neurological conditions that could affect cognitive function, such as Alzheimer's disease, stroke, or brain tumors.
- Psychiatric Conditions: Severe psychiatric disorders, including major depressive disorder or schizophrenia.
- Substance Abuse: Recent history of drug or alcohol abuse.
- Serious Medical Conditions: Uncontrolled hypertension, diabetes, heart disease, or other conditions that could interfere with study participation or outcomes.
- Severe Cognitive Impairment: Diagnosis of Parkinson's Disease Dementia (PDD).
- Other Factors Affecting Cognition: Recent head trauma, uncontrolled thyroid dysfunction, vitamin B12 deficiency, or other conditions known to affect cognitive function.
- Deep Brain Stimulation (DBS): History of DBS treatment. Participation in Other Clinical Trials: Participation in another clinical trial that could interfere with this study within the last 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing Mingzhou Rehabilitation Hospital
Nanjing, Jiangsu, 210046
Jingzhi Zhang, +86-16677137704, 170787717@qq.com
About this study
Official title: Mindfulness-Enhanced Cognitive-Motor Dual-Task Training Using Balance and Isokinetic Systems for Parkinson's Disease With Mild Cognitive Impairment: A Randomized Controlled Trial
The goal of this clinical trial is to learn if Mindfulness-Enhanced Dual-Task Training work to treat PD-MCI in adults. The main questions it aims to answer are:
Does Mindfulness-Enhanced Dual-Task Training improve the cognitive or motor function of participants? Can the combination of Dual-Task Training and Mindfulness achieve better effects?
Researchers will compare 3 groups (Dual-Task Training + Mindfulness, Dual-Task Training, and conventional motor task training) to see if Dual-Task Training and Mindfulness works to treat PD-MCI.
Participants will:
Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment
- Being tested
- Cognitive-Motor Dual-Task Training, Mindfulness Training, Single-task Training, Quiet Rest
- 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.
Cognitive-Motor Dual-Task TrainingDevice
Participants perform physical exercises using the balance training system and isokinetic muscle strength training system while simultaneously completing cognitive tasks to improve motor-cognitive coordination. The training follows a task-segmentation approach:
Balance Task Module: Participants perform dynamic balance training on the balance training system while engaging in cognitive tasks (e.g., digit span, arithmetic, or word fluency tasks).
Strength Task Module: Participants conduct isokinetic strength training while performing corresponding cognitive tasks.
Task difficulty is progressively adjusted based on participant performance.
Mindfulness TrainingOther
Guided by a professional mindfulness instructor, participants engage in mindfulness meditation to enhance attention, emotional regulation, and cognitive readiness. The training includes breath awareness, body scan, and present-moment awareness, delivered through guided meditation.
Single-task TrainingDevice
Participants perform physical exercises using the balance training system and isokinetic muscle strength training system without any concurrent cognitive tasks. The training follows a task-segmentation approach, including dynamic balance training and isokinetic strength training to enhance motor function.
Quiet RestOther
Participants remain seated in a quiet environment without engaging in mindfulness training or cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| MDT group | Experimental | Mindfulness-enhanced Dual-task Training Receives: Device: Cognitive-Motor Dual-Task Training; Other: Mindfulness Training |
| DT group | Active comparator | Dual-task Training Receives: Device: Cognitive-Motor Dual-Task Training; Other: Quiet Rest |
| ST group | Active comparator | Single-task Training Receives: Device: Single-task Training; Other: Quiet Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a widely used neuropsychological tool for detecting mild cognitive impairment (MCI). It assesses multiple cognitive domains, including attention, executive function, memory, language, visuospatial ability, abstraction, calculation, and orientation. The total score is 30 points, with higher scores indicating better cognitive function.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Mingzhou Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingzhi Zhang, Nanjing Mingzhou Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930742
- Sponsor's protocol ID
- NJKF202503001
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Enhanced Cognitive-Motor Dual-Task Training Using Balance and Isokinetic Systems for Parkinson's Disease With Mild Cognitive Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06930742
- Acronym / sponsor ID
- NJKF202503001
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nanjing Mingzhou Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 16 Apr 2025 (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 goal of this clinical trial is to learn if Mindfulness-Enhanced Dual-Task Training work to treat PD-MCI in adults. The main questions it aims to answer are:
Does Mindfulness-Enhanced Dual-Task Training improve the cognitive or motor function of participants? Can the combination of Dual-Task Training and Mindfulness achieve better effects?
Researchers will compare 3 groups (Dual-Task Training + Mindfulness, Dual-Task Training, and conventional motor task training) to see if Dual-Task Training and Mindfulness works to treat PD-MCI.
Participants will:
Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MDT group | Experimental | Device: Cognitive-Motor Dual-Task Training, Other: Mindfulness TrainingMindfulness-enhanced Dual-task Training |
| DT group | Active comparator | Device: Cognitive-Motor Dual-Task Training, Other: Quiet RestDual-task Training |
| ST group | Active comparator | Device: Single-task Training, Other: Quiet RestSingle-task Training |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: Between 55 and 75 years.
- Disease Diagnosis: Clinically diagnosed with Idiopathic Parkinson's Disease (PD) according to the UK Parkinson's Disease Society Brain Bank Criteria.
- Disease Stage: Hoehn \& Yahr (H\&Y) stages 1 to 2.5.
- Cognitive Function: Montreal Cognitive Assessment (MoCA) score between 23 and 26, indicating mild cognitive impairment (MCI).
- Medication Stability: Stable doses of antiparkinsonian medications for at least 4 weeks prior to screening.
Key exclusion criteria (7 listed)
- Other Neurological Disorders: Presence of other neurological conditions that could affect cognitive function, such as Alzheimer's disease, stroke, or brain tumors.
- Psychiatric Conditions: Severe psychiatric disorders, including major depressive disorder or schizophrenia.
- Substance Abuse: Recent history of drug or alcohol abuse.
- Serious Medical Conditions: Uncontrolled hypertension, diabetes, heart disease, or other conditions that could interfere with study participation or outcomes.
- Severe Cognitive Impairment: Diagnosis of Parkinson's Disease Dementia (PDD).
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 |
|---|---|---|
| Cognitive-Motor Dual-Task TrainingParticipants perform physical exercises using the balance training system and isokinetic muscle strength training system while simultaneously completing cognitive tasks to improve motor-cognitive coordination. The training follows a task-segmentation approach: Balance Task Module: Participants perform dynamic balance training on the balance training system while engaging in cognitive tasks (e.g., digit span, arithmetic, or word fluency tasks). Strength Task Module: Participants conduct isokinetic strength training while performing corresponding cognitive tasks. Task difficulty is progressively adjusted based on participant performance. | Device | DT group, MDT group |
| Mindfulness TrainingGuided by a professional mindfulness instructor, participants engage in mindfulness meditation to enhance attention, emotional regulation, and cognitive readiness. The training includes breath awareness, body scan, and present-moment awareness, delivered through guided meditation. | Other | MDT group |
| Single-task TrainingParticipants perform physical exercises using the balance training system and isokinetic muscle strength training system without any concurrent cognitive tasks. The training follows a task-segmentation approach, including dynamic balance training and isokinetic strength training to enhance motor function. | Device | ST group |
| Quiet RestParticipants remain seated in a quiet environment without engaging in mindfulness training or cognitive tasks. | Other | DT group, ST group |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: From enrollment to the end of treatment at 4 weeks
The Montreal Cognitive Assessment (MoCA) is a widely used neuropsychological tool for detecting mild cognitive impairment (MCI). It assesses multiple cognitive domains, including attention, executive function, memory, language, visuospatial ability, abstraction, calculation, and orientation. The total score is 30 points, with higher scores indicating better cognitive function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Motor Dual-Task Training, Mindfulness Training and Single-task Training in people with Mild Cognitive Impairment (MCI) and Parkinson's Disease (PD), run by Nanjing Mingzhou Rehabilitation Hospital at 1 site in China.
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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 16 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingzhi Zhang (+86-16677137704, 170787717@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: From enrollment to the end of treatment at 4 weeks). 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 16 Apr 2025.