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Trial registered on ANZCTR


Registration number
ACTRN12616001635459
Ethics application status
Approved
Date submitted
21/11/2016
Date registered
25/11/2016
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Date results provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of combined cognitive-exercise program in older adults with mild cognitive impairment
Scientific title
Effects of combined cognitive-exercise program on cognitive function and functional status in older adults with mild cognitive impairment
Secondary ID [1] 290597 0
UGC/FDS17/M01/16
Universal Trial Number (UTN)
U1111-1190-1675
Trial acronym
Linked study record
ACTRN12610001025022

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 301070 0
Condition category
Condition code
Mental Health 300844 300844 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8-week (group of 4-6; 3 sessions per week, 1 hour per session), center-initiated home based functional task exercise program. For the first 4 weeks, center-based sessions will be scheduled twice weekly supported with once weekly home practice with caregiver, followed by once weekly center-based and twice weekly home practice session for 4 weeks. The intervention program will be conducted by occupational therapist. Physical parameters associated with balance, strength, flexibility, mobility will be incorporated to daily functional task. All exercise sessions will begin with a 5-10 minutes warm-up consisting of light stretching designed to increase flexibility, 30-40 minutes core exercise and end with a 5-10 minutes cool-down. The core exercise includes simulated functional task (table task of placing and collection with five levels and combined with chair rise exercise) will be used according to the training protocol and training guidelines.
Compliance/ Intervention Monitor:
Attendance for center-based sessions will be registered and home exercise log will be recorded by participants and followed up during each first supervised session in the week.
Intervention code [1] 296458 0
Rehabilitation
Intervention code [2] 296467 0
Treatment: Other
Comparator / control treatment
Control group 1: Cognitive training group
The control group will receive an existing center-based computer cognitive training program (group of 4-6; 60-minutes session; 2 times/week) with home exercise for a total of 8 weeks. All the participants will continue with their usual routine medical care.
The group will be supervised by an occupational therapist using the program of RehaCom and CognitPlus for training of attention, memory, executive function, and visual perceptual function. The home program includes a 60-minutes cognitive training with a free online program ‘Love your Brain”. Compliance will be monitored with a log book.

Control group 2: Exercise training group
The control group will receive an existing exercise training program supervised by an occupational therapist (60-minutes session, 2 times/week, with home exercise for a total of 8 weeks). All exercise sessions will begin with a 5-10 minutes warm-up consisting of light stretching designed to increase flexibility, 30-40 minutes moderate intensity aerobic exercise at 4-5/10 Rate of Perceived Exertion and end with a 5-10 minutes cool-down. All the participants will continue with their usual routine medical care. Home program includes at least one session/week of 30 minutes brisk walking/ exercise bike at 4-5/10 Rate of Perceived Exertion. Compliance will be monitored with a log book.

Control group 3: Wait-list control group
No active treatment. Participants in this group may choose to receive an existing available treatment after completion of the study (5 months after randomization).
Control group
Active

Outcomes
Primary outcome [1] 300264 0
1. Chinese version of Neurobehavioral Cognitive Status Examination to assess the general cognitive function
Timepoint [1] 300264 0
Baseline, at completion (8 weeks) and 3 months after completion of intervention
Primary outcome [2] 300274 0
Composite primary outcome
2. Trail making test A and B to assess visual scanning, mental flexibility, and executive functions.
Timepoint [2] 300274 0
Baseline, at completion (8 weeks) and 3 months after completion of intervention
Primary outcome [3] 300275 0
Composite primary outcome
3. Verbal fluency test to assess speed of answer; mental organization; search strategies, and executive function.
Timepoint [3] 300275 0
Baseline, at completion (8 weeks) and 3 months after completion of intervention
Secondary outcome [1] 329538 0
Composite primary outcome
4. Verbal Learning Test to assess memory, new learning, susceptibility to interference, retention of memory and recognition memory.
Timepoint [1] 329538 0
Baseline, at completion (8 weeks) and 3 months after completion of intervention
Secondary outcome [2] 329581 0
Primary outcome
5. Problems in Everyday Living Test to assess ability of practical problem solving related to everyday life.
Timepoint [2] 329581 0
Baseline, at completion (8 weeks) and 3 months after completion of intervention
Secondary outcome [3] 329582 0
1. Berg Balance Scale to assess functional balance
Timepoint [3] 329582 0
Baseline, at completion (8 weeks) and 3 months after completion of intervention
Secondary outcome [4] 329583 0
2.Medical Outcomes 12-Item Short-Form (SF-12) Health Survey to assess health status & Quality of Life
Timepoint [4] 329583 0
Baseline, at completion (8 weeks) and 3 months after completion of intervention
Secondary outcome [5] 329584 0
3. Lawton Instrumental Activities of Daily Living Scale to assess functional status.
Timepoint [5] 329584 0
Baseline, at completion (8 weeks) and 3 months after completion of intervention
Secondary outcome [6] 329585 0
4. Zarit Caregiver Burden Interview to measure the carer burden
Timepoint [6] 329585 0
Baseline, at completion (8 weeks) and 3 months after completion of intervention

Eligibility
Key inclusion criteria
1) Memory/cognitive complaint; (2) Objective cognitive impairment in 1 or more domains (Cognistat); but with (3) intact personal selfcare functions; (4) Absence of Dementia
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) History of brain lesion/ psychoactive substance abuse/co-morbid medical condition associated with cognitive/ functional decline; (2) Clinically significant depression; (3) significant impairment of vision, hearing or communication(4) Medical conditions render patients unable to engage in physical activity, such as severe cardiac failure

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple ramdomisation using computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data set will be analyzed according to the intention-to-treat principle. Statistical comparisons will be made across the groups and across the time. All data will be analyzed using repeated measures ANOVA with two levels corresponding to the groups (interventions and comparison group) as the between subjects factor and the within-subjects factor of time represented as pre/ post and 3-month follow-up.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2017
Actual
2/05/2017
Date of last participant enrolment
Anticipated
31/10/2018
Actual
20/10/2018
Date of last data collection
Anticipated
29/03/2019
Actual
31/05/2019
Sample size
Target
160
Accrual to date
Final
145
Recruitment outside Australia
Country [1] 8407 0
Hong Kong
State/province [1] 8407 0

Funding & Sponsors
Funding source category [1] 295021 0
Government body
Name [1] 295021 0
Research Grant Council
Country [1] 295021 0
Hong Kong
Primary sponsor type
University
Name
Tung Wah College
Address
98 Shantung Street,
Mongkok, Kowloon,
Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 293839 0
None
Name [1] 293839 0
None
Address [1] 293839 0
None
Country [1] 293839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296374 0
Tung Wah College Ethics Committee
Ethics committee address [1] 296374 0
Ethics committee country [1] 296374 0
Hong Kong
Date submitted for ethics approval [1] 296374 0
25/04/2016
Approval date [1] 296374 0
30/06/2016
Ethics approval number [1] 296374 0
Ethics committee name [2] 296377 0
Hospital Authority Clinical Research Ethics Committee (Kowloon Central/Kowloon East)
Ethics committee address [2] 296377 0
Ethics committee country [2] 296377 0
Hong Kong
Date submitted for ethics approval [2] 296377 0
22/11/2016
Approval date [2] 296377 0
Ethics approval number [2] 296377 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70662 0
Dr Lawla Lan Fong Law
Address 70662 0
Occupational Therapy Discipline, James Cook Drive, Douglas. School of Public Health, Tropical Medicine and Rehabilitation Sciences, Rehabilitation and Exercise Sciences Building, James Cook University, Townsville, QLD 4811, Australia
Country 70662 0
Australia
Phone 70662 0
+61 0406480950
Fax 70662 0
Email 70662 0
lan.law@my.jcu.edu.au
Contact person for public queries
Name 70663 0
Lawla Law
Address 70663 0
Occupational Therapy Discipline, James Cook Drive, Douglas. School of Public Health, Tropical Medicine and Rehabilitation Sciences, Rehabilitation and Exercise Sciences Building, James Cook University, Townsville, QLD 4811, Australia
Country 70663 0
Australia
Phone 70663 0
+61 0406480950
Fax 70663 0
Email 70663 0
lan.law@my.jcu.edu.au
Contact person for scientific queries
Name 70664 0
Lawla Law
Address 70664 0
Occupational Therapy Discipline, James Cook Drive, Douglas. School of Public Health, Tropical Medicine and Rehabilitation Sciences, Rehabilitation and Exercise Sciences Building, James Cook University, Townsville, QLD 4811, Australia
Country 70664 0
Australia
Phone 70664 0
+61 0406480950
Fax 70664 0
Email 70664 0
lawla_law@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data are still compiling and being analysed


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of functional tasks exercise on cognitive functions of older adults with mild cognitive impairment: A randomized controlled pilot trial.2019https://dx.doi.org/10.1186/s13195-019-0548-2
N.B. These documents automatically identified may not have been verified by the study sponsor.