Mindfulness-Enhanced Dual-Task Training in PD-MCI

Nanjing Mingzhou Rehabilitation Hospital

Status: Not yet enrolling

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

Treatments: Device: Cognitive-Motor Dual-Task Training; Device: Single-task Training; Other: Mindfulness Training; Other: Quiet Rest

Study type: Interventional

Funder types: Other

Identifiers

NCT06930742

NJKF202503001

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

MDT group

Experimental group

Description:

Mindfulness-enhanced Dual-task Training

Treatment:

Other: Mindfulness Training

Device: Cognitive-Motor Dual-Task Training

DT group

Active Comparator group

Description:

Dual-task Training

Treatment:

Other: Quiet Rest

Device: Cognitive-Motor Dual-Task Training

ST group

Active Comparator group

Description:

Single-task Training

Treatment:

Other: Quiet Rest

Device: Single-task Training