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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06389812
Other study ID # LoughboroughUni
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 30, 2023
Est. completion date September 30, 2024

Study information

Verified date April 2024
Source Loughborough University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 (<10) will be removed from the study.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Dual-task exercise traning
To assess the dynamic effects of each intervention, only one session (30 mins) will be provided. The chair-based exercise session consists of three parts 5 min of active stretching exercises to warm-up, 20 mins of resistance band exercises in a sitting position (Elliott-King et al., 2019) (please see the link for detailed descriptions for seated resistance band workout) and 5 min of passive stretching exercises to cold down. The motor-cognitive dual-task group will be additionally asked to do horizontal eye movements by watching a TV screen and following a duck moving from side to side (bilateral condition) while performing strengthening exercises. The duck moves successively between left and right banks of a river at a rate of 500 ms (Brunyé et al., 2009) which was previously found to improve cognitive function

Locations

Country Name City State
United Kingdom Loughborough University Loughborough Leicestershire

Sponsors (1)

Lead Sponsor Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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