Mindfulness-Enhanced Dual-Task Training in PD-MCI

NCT06930742 | Not Yet Recruiting

• 1 other identifier: NJKF202503001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

MDT group

EXPERIMENTAL

Mindfulness-enhanced Dual-task Training

Device: Cognitive-Motor Dual-Task Training; Other: Mindfulness Training

DT group

ACTIVE COMPARATOR

Dual-task Training

Device: Cognitive-Motor Dual-Task Training; Other: Quiet Rest

ST group

ACTIVE COMPARATOR

Single-task Training

Device: Single-task Training; Other: Quiet Rest

Interventions

Cognitive-Motor Dual-Task Training 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.

DT group; MDT group

Mindfulness Training 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.

MDT group

Single-task Training 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.

ST group

Quiet Rest OTHER

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

DT group; ST group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Mingzhou Rehabilitation Hospital: lead

Study Sites (1)

Nanjing Mingzhou Rehabilitation Hospital

Nanjing, Jiangsu, 210046, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Parkinson Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Jingzhi Zhang

CONTACT

+86-16677137704; 170787717@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: technician in charge

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: May 1, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CN (1)