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Mindfulness-Enhanced Dual-Task Training in PD-MCI

Mindfulness-Enhanced Cognitive-Motor Dual-Task Training Using Balance and Isokinetic Systems for Parkinson's Disease With Mild Cognitive Impairment: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06930742
Enrollment
90
Registered
2025-04-16
Start date
2025-05-01
Completion date
2025-07-30
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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 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

Interventions

DEVICECognitive-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.

OTHERMindfulness 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.

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.

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

Sponsors

Nanjing Mingzhou Rehabilitation Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Montreal Cognitive Assessment (MoCA)From enrollment to the end of treatment at 4 weeksThe 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.

Countries

China

Contacts

Primary ContactJingzhi Zhang
170787717@qq.com+86-16677137704

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026