Clinical trial NCT06389812: Dual-task Exercise in People With Cognitive Impairment
Official title: Dynamic Neurovascular and Cognitive Response to Dual-task Exercise in People With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Older Adults
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore how performing two exercise-based tasks simultaneously (dual-task exercise) affects the neurovascular and cognitive responses of people with cognitive impairment, which is a growing concern globally. Specifically, the study will examine how motor-cognitive dual-task exercises, such as using elastic resistance bands combined with visual perception training, including eye movement exercises, can immediately improve outcomes such as Brain-derived neurotrophic factor (BDNF) levels, cerebral blood flow, cognitive function, and mobility. BDNF is a special chemical in our brain that helps with the connections between brain cells. Participants will be asked to complete a single 30-minute exercise session and undergo assessments before and after the intervention. Participants with cognitive impairment will be initially assessed using Mini-Mental State Examination (MMSE) which is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment. Participants with lower MMSE scores (\&lt;10) will be removed from the study.


Eligibility criteria: Inclusion Criteria:

* Age \&gt;65 (PwD or cognitively impaired older adults) (ICD-10)
* People with and without cognitive impairment (MMSE score 13-30)
* Subjects must be able to exercise at a moderate intensity level (see exclusion criteria)
* Subject must be willing and able to provide a blood sample

Exclusion Criteria:

* • Subjects with other neurological disease (stroke, Parkinson's, or multiple sclerosis)

  * Significant current orthopaedic (fractures, hemiplegia, pain, arthritis etc.), cardiovascular and pulmonary conditions (arrhythmias, uncontrolled hypertension, acute bronchitis, cardiac insufficiency etc.) that would limit the ability to perform cardio-respiratory fitness assessment, tasks or exercise
  * Psychiatric conditions (depression, anxiety disorder, etc.) and a history of severe psychiatric disorders (schizoaffective/bipolar disorders, or schizophrenia)
  * Severe vision/hearing impairments that cannot be corrected with aids
  * Unable to comprehend questionnaire material study procedures

Primary outcomes:
measure: BDNF serum level
timeFrame: before and immediately after treatment
Secondary outcomes:
measure: Visual screening
timeFrame: before and immediately after treatment
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
References: