- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06389812
Dual-task Exercise in People With Cognitive Impairment
April 25, 2024 updated by: Ahmet Begde, Loughborough University
Dynamic Neurovascular and Cognitive Response to Dual-task Exercise in People With Cognitive Impairment
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Leicestershire
-
Loughborough, Leicestershire, United Kingdom, LE11 3TU
- Loughborough University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dual-task group
. 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.
only one session 30 mins.
|
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
|
|
Active Comparator: eye movement exercise group
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.
only one session 30 mins.
|
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
|
|
No Intervention: control
listening a podcast.
only one session 30 mins.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BDNF serum level
Time Frame: before and immediately after treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual screening
Time Frame: before and immediately after treatment
|
visual processing speed
|
before and immediately after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2023
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
April 25, 2024
First Submitted That Met QC Criteria
April 25, 2024
First Posted (Actual)
April 29, 2024
Study Record Updates
Last Update Posted (Actual)
April 29, 2024
Last Update Submitted That Met QC Criteria
April 25, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LoughboroughUni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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