Clinical trial NCT06930742: Mindfulness-Enhanced Dual-Task Training in PD-MCI
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Parkinson's Disease (PD)
Lead sponsor: Nanjing Mingzhou Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Mingzhou Rehabilitation Hospital
state: Jiangsu
Study officials:
References: