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Not yet recruiting NCT06930742

Mindfulness-Enhanced Dual-Task Training in PD-MCI

No phase Interventional Mild Cognitive Impairment (MCI) Parkinson's Disease (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive-Motor Dual-Task Training, Mindfulness Training, Single-task Training, Quiet Rest.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI), Parkinson's Disease (PD). Basic parameters: 55 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

  • 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 isokine
  • 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.
  • 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.
  • Other Quiet Rest
    Participants remain seated in a quiet environment without engaging in mindfulness training or cognitive tasks.

Primary outcome measures

  • Montreal Cognitive Assessment (MoCA) [Time frame: From enrollment to the end of treatment at 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanjing Mingzhou Rehabilitation Hospital — Nanjing

Identifiers

NCT: NCT06930742 · NJKF202503001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗