Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001489886
Ethics application status
Approved
Date submitted
15/04/2021
Date registered
1/11/2021
Date last updated
14/02/2023
Date data sharing statement initially provided
1/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of game-based in comparison to conventional circuit exercise on functions, motivation level, self-efficacy and quality of life among stroke survivors
Scientific title
The effect of game-based in comparison to conventional circuit exercise on functions, motivation level, self-efficacy and quality of life among stroke survivors
Secondary ID [1] 303954 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Stroke 321560 0
Condition category
Condition code
Stroke 319305 319305 0 0
Haemorrhagic
Stroke 319306 319306 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The game-based circuit exercise perform in the experimental group consisted of; a) resistance exercises including sit to stand, partial squat, step up down, hip raise and heel raise, b) balance exercises including figure of eight walking, tandem walking, backward walking, walking with instruction and walking with sudden change direction and c) aerobic exercises including punching jab, hook, cross straight and combination punching manuovers and squat/kicking.

This game-based circuit exercise program was designed specifically for this study. To play Checkercise board, 4 participants will be divided into 2 small group. “Each group puts their counter on the space that says 'start'. Take it in turns to roll the dice. Move their counter forward the number of spaces shown on the dice. Exercises performed by each group are depending on the landed counter. There is also possibility of punishment if their counter lands on the ‘fate’ such as they must slide back a few spaces, move to certain board number etc. The game is over when the group gets to the space that says 'finish'”.

Exercise adherence and the level of exercise intensity (e.g. low, moderate, vigorous) will be monitored using session attendance checklists and Borg Scale Rate of Perceived Exertion, respectively.

A researcher will supervise the participants performing the Checkercise board exercise in the form of 4 participants per session. Exercise duration in each space is 2-minute interspersed by 2-min rest with total of 10 exercises to be performed in average. All participants in this group will receive 24 x 40- minute sessions, twice/week for 12 weeks.
Intervention code [1] 320266 0
Rehabilitation
Comparator / control treatment
The conventional circuit exercise will be led by 2 physiotherapists who are in charge of Gymnasium in the form of 5 participants per group per session. Exercise duration in each station is 5-minute interspersed by 2-min rest with total of 6 stations to be performed which is consisted of 1) cycling, 2) repeated sit to stand, 3) repeated arm curl, 4) repeated hip & heel raise, 5) stepping up/down and 6) obstacle walking. All participants in this group will receive 24 x 40- minute sessions, twice/week for 12 weeks.

Conventional circuit exercise without the fun and game-based element is relatively differed to the game-based exercise intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 327179 0
Lower limb strength assessed using the 30-second Chair Rise test
Timepoint [1] 327179 0
Baseline, at 12 weeks, 24 weeks and 36 weeks after intervention commencement
Primary outcome [2] 327180 0
Postural stability assessed using the Dynamic Gait Index
Timepoint [2] 327180 0
Baseline, at 12 weeks, 24 weeks and 36 weeks after intervention commencement
Primary outcome [3] 327181 0
Aerobic endurance assessed using the 6-Minute Walk test
Timepoint [3] 327181 0
Baseline, at 12 weeks, 24 weeks and 36 weeks after intervention commencement
Secondary outcome [1] 394090 0
Motivation level assessed using the Intrinsic Motivation Inventory Questionnaire
Timepoint [1] 394090 0
Baseline, at 12 weeks, 24 weeks and 36 weeks after intervention commencement
Secondary outcome [2] 394091 0
Self-efficacy assessed using the Stroke Self-Efficacy Questionnaire
Timepoint [2] 394091 0
Baseline, at 12 weeks, 24 weeks and 36 weeks after intervention commencement
Secondary outcome [3] 394092 0
Quality of life assessed using the SF-36 Quality of Life Questionnaire
Timepoint [3] 394092 0
Baseline, at 12 weeks, 24 weeks and 36 weeks after intervention commencement

Eligibility
Key inclusion criteria
Participants who are; 1) diagnosed either hemorhagic or ischemic by a Neurology physician who could be referred as early as 2 weeks after stroke which stable clinically, 2) able to perform basic instrumental activities of daily living such as walking, stepping up and turning with or without walking, hold a glass full of water with the non-affected hand, 3) an average Montreal Cognitive Assessment (MoCA) score of 22.1 and more will be recruited in this trial.
Minimum age
55 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants had, 1) Having other therapy such as home physiotherapy and traditional therapy; 2) Modified Rankin Scale score 4 to 6; 3) More than one stroke or had other neurologic disorders such as Parkinson’s Disease; 4) Severe medical illness such uncontrolled hypertension, diabetes and severe asthma; 5) Musculoskeletal conditions such as severe osteoarthritis and rheumatoid arthritis; 6) Visual field defects will be excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization will be used. This study is also using stratified randomization as group randomization method. Two confounding factors have been considered for stratification which are age (middle adult aged 55-59 years or young old aged 60-75 years) and baseline disability, which is 1 (no disability), 2 (slight disability) or 3 (moderate disability); based on Modified Rankin scale.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size has been determined by G*Power 3.1.9.7 software using F tests with ANOVA: Repeated measures, between group.

A Mixed Model ANOVA will be used to evaluate the effectiveness of game-based circuit exercises 12-week, 24 weeks and 36 weeks after intervention commencement in improving physical functions, motivation level, self-efficacy and quality of life in stroke survivor

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
1/12/2021
Date of last participant enrolment
Anticipated
1/07/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
82
Accrual to date
54
Final
Recruitment outside Australia
Country [1] 23597 0
Malaysia
State/province [1] 23597 0
WILAYAH PERSEKUTUAN PUTRAJAYA

Funding & Sponsors
Funding source category [1] 308336 0
University
Name [1] 308336 0
Universiti Kebangsaan Malaysia
Country [1] 308336 0
Malaysia
Primary sponsor type
Individual
Name
Assoc. Prof Dr Nor Azlin binti Mohd Nordin
Address
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 309152 0
Individual
Name [1] 309152 0
Dr Yusliza Azreen binti Mohd Yusoff
Address [1] 309152 0
, Medical Department, Hospital Raja Perempuan Zainab II, 15586 Kota Bharu, Kelantan
Country [1] 309152 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308311 0
National Medical Research Review, Ministry of Health
Ethics committee address [1] 308311 0
Kompleks Institut Kesihatan Negara, Blok A, No 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam 40170 Shah Alam Selangor, Malaysia
Ethics committee country [1] 308311 0
Malaysia
Date submitted for ethics approval [1] 308311 0
03/01/2020
Approval date [1] 308311 0
04/06/2020
Ethics approval number [1] 308311 0
NMRR-19-2961-51209-IIR

Summary
Brief summary
The sustainability of the effects of circuit exercises has not been proven and the element of fun in existing circuit exercises is also very lacking. These exercises also have not been tested more functionally from a functional aspect, comprehensively in terms of quality of life, and their effects on motivation level and self-efficacy. Our novelty is to innovate a form of game and turns existing circuit exercise into game-based circuit exercise and to add to literature regarding the effectiveness of game-based circuit exercise on six important post-stroke outcomes of stroke survivors, namely lower limb strength, postural stability, aerobic capacity, motivation level, self-efficacy and quality of life. The research hypothesis is 12-week game-based circuit exercise is more effective conventional circuit exercise in improving physical functions, motivation level, self-efficacy and quality of life in stroke survivor. Thus, aim of this study is to evaluate the effectiveness of 12-week game-based circuit exercise in improving physical functions, motivation level, self-efficacy and quality of life among stroke survivor following game-based in comparison to conventional circuit exercise. This study also aims assess whether the outcomes gained from the two interventions could be sustained at 12-week and 24-weekpost trial. A total of 82 stroke survivors will be allocated either in the experimental group (participants received game-based circuit exercise) or the control group (participants will undergone conventional circuit exercise). Both group will be led by therapist, in-hospital; 24 therapy sessions, twice per week for 12 continuous weeks. Changes in physical functions, motivation level, self-efficacy and quality of life will be assessed using the 30-second Chair Rise test, Dynamic Gait Index, 6-minute Walk test, Intrinsic Motivation Inventory Questionnaire, Stroke Self-Efficacy Questionnaire and Short Form-36, respectively. The baseline status at 0-week, therapy outcomes at 12th-week and sustainability at 24th-week and 36th-week will be measured by an independent assessor. Finding from this study may be used as a therapy option in the rehabilitation of this patient population.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110262 0
Mr Mohd Naqiuddin Johar
Address 110262 0
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia
Country 110262 0
Malaysia
Phone 110262 0
+60326914304
Fax 110262 0
+60392897522
Email 110262 0
[email protected]
Contact person for public queries
Name 110263 0
Mr Mohd Naqiuddin Johar
Address 110263 0
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia
Country 110263 0
Malaysia
Phone 110263 0
+60326914304
Fax 110263 0
+60392897522
Email 110263 0
[email protected]
Contact person for scientific queries
Name 110264 0
Mr Mohd Naqiuddin Johar
Address 110264 0
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia
Country 110264 0
Malaysia
Phone 110264 0
+60326914304
Fax 110264 0
+60392897522
Email 110264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For participants' confidential purposes


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11375Ethical approval    381801-(Uploaded-15-04-2021-11-51-49)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of game-based in comparison to conventional circuit exercise on functions, motivation level, self-efficacy and quality of life among stroke survivors.2022https://dx.doi.org/10.1097/MD.0000000000028580
N.B. These documents automatically identified may not have been verified by the study sponsor.