StrokeNCT07603102
Mindfulness With Dual-Task Training in Post-Stroke Mild Cognitive Impairment
A study testing mindfulness, Dual-Task Training and Aerobic Training in people with Stroke and Mild Cognitive Impairment (MCI), run by Nanjing Mingzhou Rehabilitation Hospital at 1 site in China.
Trial summary
This study aims to investigate whether a combined intervention of mindfulness and dual-task training can improve cognitive function and physical performance in individuals with mild cognitive impairment after stroke. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke, Mild Cognitive Impairment (MCI)
- What is being tested?
- mindfulness, Dual-Task Training and Aerobic Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI).
- Time since stroke onset ≥3 months and medically stable.
- Presence of mild cognitive impairment after stroke, defined by a Montreal - - Montreal Cognitive Assessment (MoCA) score < 26.
- Mini-Mental State Examination (MMSE) score ≥ 24.
- Ability to walk independently with or without an assistive device for at least 10 meters.
- Stable medication regimen for at least 4 weeks prior to enrollment.
- Ability to understand study instructions and provide written informed consent.
Who cannot join
- Severe aphasia, visual impairment, hearing impairment, or communication disorders that interfere with assessment or training participation.
- Severe depression or other major psychiatric disorders.
- Other neurological diseases affecting cognition or movement (e.g., Parkinson's disease, multiple sclerosis, traumatic brain injury).
- Severe musculoskeletal, cardiovascular, or systemic diseases that contraindicate exercise participation.
- Participation in other structured cognitive or rehabilitation intervention programs within the past 3 months.
- Unstable medical condition or recurrent stroke during the study period.
- Inability to safely complete the training protocol as determined by the study investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Mingzhou Rehabilitation Hospital
Nanjing
Jingzhi Zhang, +86-16677137704, 170787717@qq.com
About this study
Official title: Mindfulness Combined With Dual-Task Training for Post-Stroke Mild Cognitive Impairment: A Randomized Controlled Trial
This study aims to investigate whether a combined intervention of mindfulness and dual-task training can improve cognitive function and physical performance in individuals with mild cognitive impairment after stroke.
- Conditions
- Stroke, Mild Cognitive Impairment (MCI)
- Being tested
- mindfulness, Dual-Task Training, Aerobic Training, Health education
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulnessOther
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.Other Name:
Dual-Task TrainingDevice
Dual-task training is a rehabilitation approach that targets cognitive-motor integration by requiring participants to perform a motor task and a cognitive task simultaneously. Examples include walking while performing mental calculations, memory tasks, or reaction-based exercises. The training is progressively adjusted by increasing task difficulty and cognitive load to improve attention allocation, executive function, and dual-task performance in daily activities.
Aerobic TrainingDevice
Dual-task training is a rehabilitation approach that targets cognitive-motor integration by requiring participants to perform a motor task and a cognitive task simultaneously. Examples include walking while performing mental calculations, memory tasks, or reaction-based exercises. The training is progressively adjusted by increasing task difficulty and cognitive load to improve attention allocation, executive function, and dual-task performance in daily activities.
Health educationOther
Health education is a non-exercise control intervention designed to provide participants with knowledge related to post-stroke health management. Topics include stroke recovery, healthy lifestyle behaviors, nutrition, medication adherence, daily activity management, and psychological well-being. The intervention is delivered through structured educational sessions or instructional materials and does not include active physical or cognitive training components.
| Study group | Role | What they receive |
|---|---|---|
| MDT group | Experimental | Mindfulness + Dual-Task Training Receives: Other: mindfulness; Device: Dual-Task Training |
| DT group | Experimental | Dual-Task Training + Health Education Receives: Device: Dual-Task Training; Other: Health education |
| AT group | Experimental | Aerobic Training + Health Education Receives: Device: Aerobic Training; Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 May 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Mingzhou Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingzhi Zhang, Nanjing Mingzhou Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603102
- Sponsor's protocol ID
- NJKF202605002
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Combined With Dual-Task Training for Post-Stroke Mild Cognitive Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07603102
- Acronym / sponsor ID
- NJKF202605002
- Conditions
- Stroke, Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing Mingzhou Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether a combined intervention of mindfulness and dual-task training can improve cognitive function and physical performance in individuals with mild cognitive impairment after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MDT group | Experimental | Other: mindfulness, Device: Dual-Task TrainingMindfulness + Dual-Task Training |
| DT group | Experimental | Device: Dual-Task Training, Other: Health educationDual-Task Training + Health Education |
| AT group | Experimental | Device: Aerobic Training, Other: Health educationAerobic Training + Health Education |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI).
- Time since stroke onset ≥3 months and medically stable.
- Presence of mild cognitive impairment after stroke, defined by a Montreal - - Montreal Cognitive Assessment (MoCA) score < 26.
- Mini-Mental State Examination (MMSE) score ≥ 24.
- Ability to walk independently with or without an assistive device for at least 10 meters.
Key exclusion criteria (7 listed)
- Severe aphasia, visual impairment, hearing impairment, or communication disorders that interfere with assessment or training participation.
- Severe depression or other major psychiatric disorders.
- Other neurological diseases affecting cognition or movement (e.g., Parkinson's disease, multiple sclerosis, traumatic brain injury).
- Severe musculoskeletal, cardiovascular, or systemic diseases that contraindicate exercise participation.
- Participation in other structured cognitive or rehabilitation intervention programs within the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulnessGuided 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.Other Name: | Other | MDT group |
| Dual-Task TrainingDual-task training is a rehabilitation approach that targets cognitive-motor integration by requiring participants to perform a motor task and a cognitive task simultaneously. Examples include walking while performing mental calculations, memory tasks, or reaction-based exercises. The training is progressively adjusted by increasing task difficulty and cognitive load to improve attention allocation, executive function, and dual-task performance in daily activities. | Device | DT group, MDT group |
| Aerobic TrainingDual-task training is a rehabilitation approach that targets cognitive-motor integration by requiring participants to perform a motor task and a cognitive task simultaneously. Examples include walking while performing mental calculations, memory tasks, or reaction-based exercises. The training is progressively adjusted by increasing task difficulty and cognitive load to improve attention allocation, executive function, and dual-task performance in daily activities. | Device | AT group |
| Health educationHealth education is a non-exercise control intervention designed to provide participants with knowledge related to post-stroke health management. Topics include stroke recovery, healthy lifestyle behaviors, nutrition, medication adherence, daily activity management, and psychological well-being. The intervention is delivered through structured educational sessions or instructional materials and does not include active physical or cognitive training components. | Other | AT group, DT group |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: From enrollment to the end of treatment at 4 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness, Dual-Task Training and Aerobic Training in people with Stroke and Mild Cognitive Impairment (MCI), run by Nanjing Mingzhou Rehabilitation Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingzhi Zhang (+86-16677137704, 170787717@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.