Dementia Clinical Trial
Official title:
Dynamic Neurovascular and Cognitive Response to Dual-task Exercise in People With Cognitive Impairment
Verified date | April 2024 |
Source | Loughborough University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 (<10) will be removed from the study.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | September 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Age >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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Loughborough University | Loughborough | Leicestershire |
Lead Sponsor | Collaborator |
---|---|
Loughborough University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BDNF serum level | Blood samples will be drawn from the antecubital vein by venepuncture in dry vacuum tubes immediately before the beginning of the exercise training and within 5 min from the termination of the exercise session. Serum will be obtained by the centrifugation of blood (2,000 g for 10 min, 4°C) and then all serum samples will be stored at -80°C until analysis (Máderová et al., 2019). | before and immediately after treatment | |
Secondary | Visual screening | visual processing speed | before and immediately after treatment |
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