Mindfulness-Enhanced Dual-Task Training in PD-MCI

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanjing Mingzhou Rehabilitation Hospital — Нанкин

Идентификаторы

NCT: NCT06930742 · NJKF202503001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗