Mindfulness-Enhanced Dual-Task Training in PD-MCI

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorNanjing Mingzhou Rehabilitation Hospital

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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 intervention

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: MDT groupExperimental treatment 2 interventions
Group B: DT groupActive comparator 2 interventions
Group C: ST groupActive comparator 2 interventions

Trial outcomes

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.

Time frame
From enrollment to the end of treatment at 4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: