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NCT Number: NCT06930742

Mindfulness-Enhanced Dual-Task Training in PD-MCI

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

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Key information

Conditions

Mild Cognitive Impairment (MCI) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinson's Disease (PD) Parkinsonian Disorders Synucleinopathies

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Quiet Rest

Other

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingzhi Zhang

CONTACT

[email protected]

+86-16677137704

Sponsors and collaborators

Lead sponsor

Nanjing Mingzhou Rehabilitation Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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