Home » Trials » SLCTR/2024/010


EFFECTS OF AN AEROBIC EXERCISE AND COGNITIVE TRAINING PROGRAM ON COGNITIVE FUNCTION, AND BRAIN ELECTRICAL ACTIVITY AMONG PERSONS WITH STROKE

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SLCTR Registration Number

SLCTR/2024/010


Date of Registration

15 Mar 2024

The date of last modification

Mar 15, 2024



Application Summary


Scientific Title of Trial

EFFECTS OF AN AEROBIC EXERCISE AND COGNITIVE TRAINING PROGRAM ON COGNITIVE FUNCTION, AND BRAIN ELECTRICAL ACTIVITY AMONG PERSONS WITH STROKE


Public Title of Trial

EFFECTS OF ANAEROBIC EXERCISE AND COGNITIVE TRAINING PROGRAM VERSUS STANDARD CARE, ON COGNITIVE FUNCTION, AND BRAIN ELECTRICAL ACTIVITY AMONG PERSONS WITH ISCHAEMIC STROKE


Disease or Health Condition(s) Studied

ischemic stroke


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1301-9868


Any other number(s) assigned to the trial and issuing authority

None


Trial Details


What is the research question being addressed?

What are the effects of an exercise and cognitive training program on cognitive function and brain electrical activity in persons with ischaemic stroke compared with usual care alone?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Participants, Investigators, Healthcare providers


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Prevention


Study Phase

Not Available


Intervention(s) planned

Study site Nakornping hospital, Chiangmai province, Thailand.

Randomization: Eligible participants will be randomly assigned to intervention or control groups using numbers in sealed envelopes (1 = intervention group, 2 = control group). All participants had an equal opportunity for selection.

Intervention: The AEROBIC EXERCISE AND COGNITIVE TRAINING (AECT) program will be conducted in 4 sessions within 4 weeks, one week apart, each session 60-90 minutes, then 4-week follow up for maintaining aerobic exercise and cognitive training by using Line Application at week 5th, 6th, 7th, and home visit at 8th. The interventions will start at separate room of stroke unit or internal medical ward. At pre-test (0 week), post-test (4th week), and follow up (8th week), the research assistant will assess the BMET score, and the researcher will measure brain electrical activity of participants. The interventions consist of 4 sessions as follows:

Session 1: Day 3 or Day 4 of admission in Internal Medicine Ward or Stroke Unit (60-90 minutes), the researcher will meet with participants and their family at stroke unit or internal medical ward. This session focused on understanding the reality of ischemic stroke and cognitive function among persons with ischemic stroke, and set goals for improving cognitive function, and to promote ability of aerobic exercise and cognitive training behavior. The participants will be received usual care 5 days from the internal medical ward nurse, including an orienting about the rules in the ward, information about ischemic stroke, hygiene care, and how to prevent complication. Nurse provides nursing care by monitor and measurement vital sign, assess Barthel ADL modify ranking scale, hygiene care, administer medication, provide emotional support to patients and their families, and preparing discharge planning in collaborative with physician, nurse ward, pharmacist, physiotherapist, and occupational therapist. The session intervened as follows: 1. The researcher introducing researcher and person with stroke and their family with welcoming manner, respect, non-judgmental, and generosity. 2. Explaining research objectives, program details and provides information to persons with stroke about cognitive function among persons with ischemic stroke. 3. Discussing about beliefs, expectation and behaviors relevant to increase AECT behavior wit person with stroke and their family. 4. Explaining the importance of AECT for the recovery of cognitive function. 5. Discussing goal, goal congruence and outcome expectation. 6. Setting the goal and outcome to increasing AECT behavior of person with stroke and family. 7. Describing objectives and outlines of the program. 8. Providing information to person with stroke and family about AECT intervention (Manual: Aerobic exercise and Cognitive Training). 9. Offering the commendation to person with stroke and their family for their intention to increase AECT behavior. 10. Teaching and training skills of person with stroke and their family about knowledge, exercise skill and arranging family environment to promote AECT behavior by providing the manual and information. 11. Encouraging modeling of aerobic exercise and cognitive training behavior to promote self-efficacy.

Session 2: Day 6 or Day 7 of second week (30-60 minutes), this session focus on supporting and maintaining aerobic exercise and cognitive training behavior the researcher will support and maintain behavior by line application. The session intervened as follows: 1. Monitoring the AECT exercise behavior from diary record by asking via line application or calling. 2. Providing the updated information and negotiated collaboration between person with stroke and their family. 3. Encouraging the person with stroke and their family to express their feeling and ability to continue AECT. 4. Discussing the changes and ensuring cognitive and behavioral changes of person with stroke and their family and making commendation on their competence. 5. Inviting person with stroke and their family for reflecting and feedback about the interventions. 6. Discussing with person with stroke and their family about additional plans or ideas related to person with stroke and their family practices that they would like to do next.

Session 3: Day 6 or Day 7 of third week (30-60 minutes), this session focus on supporting and maintaining aerobic exercise and cognitive training behavior the researcher will support and maintain behavior by line application. The session intervened as follows: 1. Monitoring the AECT exercise behavior from diary record by asking via line application or calling. 2. Providing the updated information and negotiated collaboration between person with stroke and their family. 3. Encouraging the person with stroke and their family to express their feeling and ability to continue AECT. 4. Discussing the changes and ensuring cognitive and behavioral changes of person with stroke and their family and making commendation on their competence. 5. Inviting person with stroke and their family for reflecting and feedback about the interventions. 6. Discussing with person with stroke and their family about additional plans or ideas related to person with stroke and their family practices that they would like to do next.

Session 4: Day 6 or Day 7 of forth weeks (60 minute), the researcher will meet persons with stroke and their families at their home-by-home visit. The RA-B will assess BMET, and researcher will measure brain electrical activity for post-test. The intervention will focus on supporting, maintaining and evaluating the aerobic exercise and cognitive training program and change. The session will be intervened as follows: 1. Monitoring the AECT exercise behavior from diary record by asking via line application or calling. 2. Providing the updated information and negotiated collaboration between person with stroke and their family. 3. Encouraging the person with stroke and their family to express their feeling and ability to continue AECT. 4. Discussing the changes and ensuring cognitive and behavioral changes of person with stroke and their family and making commendation on their competence. 5. Inviting person with stroke and their family for reflecting and feedback about the interventions. 6. Discussing with person with stroke and their family about additional plans or ideas related to person with stroke and their family practices that they would like to do next.

The intervention for the control group/standard care The participants in control group will be received usual care 5 days from the internal medical ward nurse, including an orienting about the rules in the ward, information about ischemic stroke, hygiene care, and how to prevent complication. Nurse provides nursing care by monitor and measurement vital sign, assess Barthel ADL modify ranking scale, hygiene care, administer medication, provide emotional support to patients and their families, and preparing discharge planning in collaborative with physician, nurse ward, pharmacist, physiotherapist, and occupational therapist.


Inclusion criteria

1) A first ischemic stroke in early sub-acute phase (the first 3 months) with age 18-60, both male and female who lived in Chiangmai province, 2) No other neurodegenerative disorders such as Alzheimer. 3) No previous psychiatric history or alcoholism from medical record, 3) Able to communicate in Thai language, 4) had muscle strength grading score 4 or more measured by muscle strength grading testing, 5) BMET score below 14, 6) having family caregiver, and 7) right-handed person.


Exclusion criteria

1) Participants are referred or moved to other hospital 2) Are readmitted to the hospital with complications from the stroke or co-morbid disease, 3) Do not completely participate in the program 4) Those who received endovascular thrombectomy (EVT).



Primary outcome(s)

1.

Brain Electrical Activity. Brain electrical activity will be measured by the emotive EPOC neuroheadset, the emotive EPOC neuroheadset has 14-channel EEG for whole brain sensing use to measure an EEG signal brainwave which categorized by frequency of the speed of the electrical oscillations, is measured in cycles per second [one Hertz (Hz) is equal to one cycle per second].

[

At pre-test (0 week), post-test (4th week), and follow up (8th week)

]

Secondary outcome(s)

1.

Cognitive Function Cognitive function will be measured by The Brief Memory and Executive Test (BMET). BMET is a short neuropsychological screening tool which takes approximately 10 minutes to administer. The BMET includes tests of executive functioning, processing speed, memory and orientation.

[

At pre-test (0 week), post-test (4th week), and follow up (8th week)

]

Target number/sample size

50 (25 in each arm)


Countries of recruitment

Thailand


Anticipated start date

2024-03-15


Anticipated end date

2024-12-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals

None



State of Ethics Review Approval


Status

Approved


Date of Approval

2023-11-29


Approval number

IRB3-119/2556


Details of Ethics Review Committee

Name: Burapha University Ethics Committee
Institutional Address:Burapha University 169 Longhard Bangsean Road, Saensuk, Muang Chonburi, 20131
Telephone:+6638102561-62
Email: research@buu.ac.th

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Pennapa tajit
Lecturer
Faculty of Nursing, Chiangrai College 199 Moo 6, Thumbol Pa O Don Chai, Aumpher Muang, Chiangrai, 57000, Thailand.
66-0-5317-0331
66-0-8691-07369
66-053-170335
pennapatajit@gmail.com
http://www.crc.ac.th

Contact Person for Public Queries

Dr. Chintana Wacharasin
Associate Professor.
Faculty of Nursing, Burapha University 169 Long-Hard BangsaenRoad, Tambon Saensook, Amphur Muang, Chonburi 20131, Thailand
+66-0-3810-892


chintana@buu.ac.th
http://www.crc.ac.th


Primary study sponsor/organization

Faculty of Nursing, Burapha University
Educational institution being studied.
Faculty of Nursing, Burapha University 169 Long-Hard BangsaenRoad, Tambon Saensook, Amphur Muang, Chonburi 20131, Thailand.
66-0-3810-2222 Ext 2880
66-038-393746
admin@nurse.buu.ac.th
http://www.nurse.buu.ac.th/en/home.php

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results