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

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 Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment (MCI); Parkinson's Disease (PD)
• Intervention / Treatment: Device: Cognitive-Motor Dual-Task Training; Other: Mindfulness Training; Other: Quiet Rest; Device: Single-task Training

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingzhi Zhang; Phone Number: +86-16677137704; Email: 170787717@qq.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210046
      • Nanjing Mingzhou Rehabilitation Hospital
      • Contact: Jingzhi Zhang; Phone Number: +86-16677137704; Email: 170787717@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDT group; Mindfulness-enhanced Dual-task Training	Device: 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.; Other: 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.
Active Comparator: DT group; Dual-task Training	Device: 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.; Other: Quiet Rest; Participants remain seated in a quiet environment without engaging in mindfulness training or cognitive tasks.
Active Comparator: ST group; Single-task Training	Other: Quiet Rest; Participants remain seated in a quiet environment without engaging in mindfulness training or cognitive tasks.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: Nanjing Mingzhou Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Cognitive Dysfunction; Parkinson Disease
• Other Study ID Numbers: NJKF202503001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No