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Trial registered on ANZCTR


Registration number
ACTRN12610001025022
Ethics application status
Approved
Date submitted
20/11/2010
Date registered
23/11/2010
Date last updated
10/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Functional Task Exercise Program on Older Adults with Cognitive Impairment at Risk of Alzheimer Disease
Scientific title
Effects of Functional Task Exercise Program on Cognitive, Functional and Health status of Older Adults with Cognitive Impairment at Risk of Alzheimer Disease – A randomized Controlled Trial
Secondary ID [1] 253142 0
Nil
Universal Trial Number (UTN)
U1111-1117-9270
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 258687 0
Condition category
Condition code
Neurological 258835 258835 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10-week (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, then once biweekly center-based sessions for the last 2 weeks. The intervention program will be conducted by occupational therapist. Physical parameters associated with balance, strength, flexibility, mobility will be incorporated to daily functional tasks. All exercise sessions began with a 5-10 minute warm-up consisting of light stretching designed to increase flexibility, 30-40 minute core exercise and end with a 5-10 minute cool-down. Functional tasks for core exercise include table task and dinning task will be used according to the training protocol and training guidelines.
Intervention code [1] 257647 0
Rehabilitation
Comparator / control treatment
The control group will receive an existing computer cognitive training program (1x 60 minute session,once weekly for week1-2 and once bi-weekly for week 3-10, with home exercise in a total of 10 weeks). All the participants will continue with their usual routine medical care.
Control group
Active

Outcomes
Primary outcome [1] 259695 0
Chinese version of Neurobehavioral Cognitive Status Examination
Timepoint [1] 259695 0
Baseline, at completion (10 weeks) and 3 months after completion of intervention
Primary outcome [2] 259696 0
Specific cognitive functions: Trail making test A and B to assess visual scanning mental flexibility, and executive functions. Verbal fluency test to assess speed of answer; mental organization; search strategies, and short- and long-term Memory. Auditory-Verbal Learning Test to assess evaluates immediate memory span, new learning, susceptibility to interference, retention of memory and recognition memory. Problems in Everyday Living Test to assess ability of practical problem solving related to everyday life.
Timepoint [2] 259696 0
Baseline, at completion (10 weeks) and 3 months after completion of intervention
Secondary outcome [1] 266401 0
Health status & Quality of Life: Medical Outcomes 12-Item Short-Form (SF-12) Health Survey
Timepoint [1] 266401 0
Baseline, at completion (10 weeks) and 3 months after completion of intervention
Secondary outcome [2] 266402 0
Functional Status: Activities of Daily Living Questionnaire and Lawton Instrument Activities of Daily Living Scale to assess functional level.
Zarit Caregiver Burden Interview to measure the carer burden
Timepoint [2] 266402 0
Baseline, at completion (10 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; but with (3) intact personal selfcare functions; (4) Absence of Dementia
Minimum age
60 Years
Maximum age
No limit
Gender
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)
Central randomisation by computer
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3059 0
Hong Kong
State/province [1] 3059 0
Kowloon

Funding & Sponsors
Funding source category [1] 258110 0
University
Name [1] 258110 0
James Cook University
Address [1] 258110 0
Occupational Therapy Discipline
School of Public Health, Tropical Medicine & Rehabilitation Sciences
James Cook University, James Cook Drive
Douglas
Townsville QLD 4811
Country [1] 258110 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
Occupational Therapy Discipline
School of Public Health, Tropical Medicine & Rehabilitation Sciences
James Cook University, James Cook Drive
Douglas
Townsville QLD 4811
Country
Australia
Secondary sponsor category [1] 257290 0
Hospital
Name [1] 257290 0
Occupational therapy department, United Christian Hospital, Hong Kong
Address [1] 257290 0
130 Hip Wo Street, Kwun Tong, KLN, Hong Kong
Country [1] 257290 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260094 0
Tasmania Health & Medical Human Research Ethics Committee (EC00337)
Ethics committee address [1] 260094 0
Private Bag 1 Sandy Bay, Hobart, Tasmania 7001
Ethics committee country [1] 260094 0
Australia
Date submitted for ethics approval [1] 260094 0
01/12/2010
Approval date [1] 260094 0
Ethics approval number [1] 260094 0
Ethics committee name [2] 260095 0
James Cook University Human Research Ethics Committee (EC00164)
Ethics committee address [2] 260095 0
Research Ethics and Grants Research Office
Room 021 A, Ground Floor
Kevin Stark Research Building (DB019)
James Cook University
James Cook Drive
Douglas QLD 4811
Ethics committee country [2] 260095 0
Australia
Date submitted for ethics approval [2] 260095 0
01/02/2011
Approval date [2] 260095 0
06/09/2011
Ethics approval number [2] 260095 0
Ethics committee name [3] 286740 0
Research Ethics Committee (Kowloon Central/Kowloon East)
Ethics committee address [3] 286740 0
Queen Elizabeth Hospital,
30 Gascoigne Road, Kowloon,
Hong Kong
Ethics committee country [3] 286740 0
Hong Kong
Date submitted for ethics approval [3] 286740 0
Approval date [3] 286740 0
06/07/2011
Ethics approval number [3] 286740 0
REC (KC/KE): KC-KE 11-0097/ER-3

Summary
Brief summary
The main aim of the present study is to determine whether a functional task exercise program supervised by caregivers would improve the cognitive function of cognitive decline older adults at risk for Alzheimer’s Disease (AD) in a randomized controlled trial. It is also hypothesized that functional task exercises can improve the capacity of everyday problem solving. A further aim is to assess whether the use of meaningful functional tasks as intervention media would reduce functional decline and promote a sense of satisfaction in older adults with cognitive decline.
Trial website
Trial related presentations / publications
1. Lawla L F Law; Fiona Barnett, Matthew K Yau, and Marion A Gray (2013). Development and initial testing of Functional Tasks Exercise on Older Adults with Cognitive Impairment at Risk of Alzheimer Disease –FcTSim program a feasibility study. Occupational Therapy International, June 2013, early view published online.

2. Lawla L F Law; Fiona Barnett, Matthew K Yau, and Marion A Gray (under review). Effects of Functional Tasks Exercise on Older Adults with Cognitive Impairment at Risk of Alzheimer Disease – A randomized controlled trial.
Public notes

Contacts
Principal investigator
Name 31937 0
Dr Lan Fong Law
Address 31937 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 31937 0
Australia
Phone 31937 0
+61 7 47816678
Fax 31937 0
Email 31937 0
lan.law@my.jcu.edu.au
Contact person for public queries
Name 15184 0
Dr Lan Fong Law
Address 15184 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 15184 0
Australia
Phone 15184 0
+61 7 47816678
Fax 15184 0
+61 7 47816868
Email 15184 0
lan.law@my.jcu.edu.au
Contact person for scientific queries
Name 6112 0
Dr Lan Fong Law
Address 6112 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 6112 0
Australia
Phone 6112 0
+61 7 47816678
Fax 6112 0
+61 7 47816868
Email 6112 0
lan.law@my.jcu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary