None listed
Conditions
Brief summary
Mobility and falls are common in people with cognitive impairment/complaints. We aim to test whether a balance and cognitive training program delivered at home via a computer application and tablet will improve risk factors for falls such as mobility, balance and brain function. Hypotheses Compared to a health education program, a 6-month home-based exercise training program delivered via a tablet computer (Standing Tall-COG) will improve the following in people with cognitive impairment (this term includes both objective and subjective cognitive complaints). Primary Outcome 1. Gait speed Secondary Outcome 2. Gait and cognitive dual-task cost 3. Balance under single and dual-task 4. Muscle strength, reaction time 5. Cognitive function 6. Activities of daily living 7. Balance confidence 8. LifeSpace Exploratory outcome - falls over 6 months
Interventions
Brief name: Balance and dual-task training delivered by a computer application and tablet
Full description: Balance and dual-task training exercises will be delivered by a computer application. Examples include: standing semi-tandem, tandem, standing on one leg, squats, lunges, standing on foam, stepping onto a step or in different directions. Activities are progressed to be performed while doing an additional cognitive (eg reciting animals, remembering a location to step) or motor task (eg ben
Brief name: Balance and dual-task training delivered by a computer application and tablet Full description: Balance and dual-task training exercises will be delivered by a computer application. Examples include: standing semi-tandem, tandem, standing on one leg, squats, lunges, standing on foam, stepping onto a step or in different directions. Activities are progressed to be performed while doing an additional cognitive (eg reciting animals, remembering a location to step) or motor task (eg bending elbows). Instructions for each exercise are presented with text or via video on the tablet (provided to participants in the intervention group). A manual will be provided as well as a step and foam square to increase the exercise difficulty. An initial visit to the persons home by an exercise physiologist /physiotherapist will be undertaken to explain the use of the app and equipment, tailor the program to the person’s ability and optimise safety (approximately 1 week after the initial assessment). A further visit will occur in ~ weeks 3 and 8 to ensure correct use, as well as monthly phone calls. Features of the application include an activity planner, reminders and feedback, and participant adherence data is fed back to researchers via a secure server. This will be examined by the trainer and addressed in visits or phone calls as mentioned above. The intervention will last 6 months with the following dose and progression (frequency is optional - the participants can choose to do the prescribed weekly minutes all at once or in part eg 10 min blocks): Week Duration (min) Weeks 1-2= 40min/week Weeks 3-4=60min/week Weeks 5-6=80min/week Weeks 7-8=100min/week Weeks 9-24 =120min/week The difficulty of the exercises increases depending on the rating by the participant of each exercise - this is done by an inbuilt algorithm tested in our previous study - Delbaere Kim et al https://www.ncbi.nlm.nih.gov/pubmed/26493461#. Adherence is also recorded on the app and delivered to a secure server. Both groups will receive a health education fact sheet for every week (most are designed for the study with a few from https://yourbrainmatters.org.au/5-simple-steps).
Sponsors
Dr Michele Callisaya
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures 3. Ability to perform exercises and be willing to adhere to the study intervention regimen for 6 months and attend the pre and post assessments 4. Cognitive impairment (Montreal cognitive assessment 19-26 or medical diagnosis) or reporting a subjective cognitive complaint 5. Ability to walk in own home without a gait aide or needing to hold onto furniture 6. Sufficient vision and English language to read & understand the instructions on the tablet 7. Accept that they may be randomised to either intervention
Exclusion criteria
1. Unstable or acute medical condition that precludes participation 2. Neurological condition such as Parkinson’s disease or multiple sclerosis, stroke 3. Diagnosis of dementia by a health professional OR a score of < 19 on the Montreal Cognitive Assessment OR a score of 19-26 on the Montreal Cognitive Assessment AND a score of >9 on the Functional Activities Questionnaire OR Clinical judgement by psychologist/study staff that participant is unable to carry out the exercises safely and independently and the participant has no partner/friend to assist with the program at home. 4. Residing in a nursing home 5. Currently participating in another clinical trial that would bias outcomes 6. Currently participating in another exercise program designed to improve balance. 7. Chest pain or dizziness with exercise 8. Substantial shortness of breath when walking 9. Life expectancy less than 12 months 10. Insufficient vision to use the computer application.
Outcome results
None listed