NCT06389812

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 (\<10) will be removed from the study.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

April 25, 2024

Last Update Submit

April 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Visual screening

    before and immediately after treatment

Study Arms (3)

Dual-task group

EXPERIMENTAL

. 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.

Other: Dual-task exercise traning

eye movement exercise group

ACTIVE COMPARATOR

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.

Other: Dual-task exercise traning

control

NO INTERVENTION

listening a podcast. only one session 30 mins.

Interventions

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

Dual-task groupeye movement exercise group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \>65 (PwD or cognitively impaired older adults) (ICD-10)
  • People with and without cognitive impairment (MMSE score 13-30)

You may not qualify if:

  • Subject must be willing and able to provide a blood sample
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

DementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 29, 2024

Study Start

August 30, 2023

Primary Completion

April 30, 2024

Study Completion

September 30, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations