Mindfulness-Enhanced Dual-Task Training in PD-MCI

NCT ID: NCT06930742

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-07-30

Brief Summary

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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

Detailed Description

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Conditions

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Mild Cognitive Impairment (MCI) Parkinson's Disease (PD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MDT group

Mindfulness-enhanced Dual-task Training

Group Type EXPERIMENTAL

Cognitive-Motor Dual-Task Training

Intervention Type DEVICE

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 Training

Intervention Type OTHER

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.

DT group

Dual-task Training

Group Type ACTIVE_COMPARATOR

Cognitive-Motor Dual-Task Training

Intervention Type DEVICE

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.

Quiet Rest

Intervention Type OTHER

Participants remain seated in a quiet environment without engaging in mindfulness training or cognitive tasks.

ST group

Single-task Training

Group Type ACTIVE_COMPARATOR

Single-task Training

Intervention Type DEVICE

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 Rest

Intervention Type OTHER

Participants remain seated in a quiet environment without engaging in mindfulness training or cognitive tasks.

Interventions

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Cognitive-Motor Dual-Task Training

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.

Intervention Type DEVICE

Mindfulness Training

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.

Intervention Type OTHER

Single-task Training

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.

Intervention Type DEVICE

Quiet Rest

Participants remain seated in a quiet environment without engaging in mindfulness training or cognitive tasks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Mingzhou Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jingzhi Zhang

technician in charge

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nanjing Mingzhou Rehabilitation Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Jingzhi Zhang

Role: CONTACT

+86-16677137704

Facility Contacts

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Jingzhi Zhang

Role: primary

+86-16677137704

Other Identifiers

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NJKF202503001

Identifier Type: -

Identifier Source: org_study_id

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