None listed
Conditions
Brief summary
This study aims to investigate whether a 12-week combined psychoeducation and home-based exercise intervention can improve dementia risk, mood, health knowledge, cognition, sleep, metabolic markers and brain connectivity in older adults with cognitive difficulties. The active intervention will comprise an individually prescribed, home-based exercise and psychoeducation program. Results will be compared to an active waitlist control group, who will be offered the psychoeducation program at the end of the trial.
Interventions
The ‘CogStep Phase 2.0’ Intervention will comprise a program of combined home based exercise and psycho-education for a period of 12 weeks. The treatment program comprises two distinct parts:
Exercise Prescription: Immediately following the baseline assessments, an Exercise Physiologist will prescribe six individually tailored strength, balance and/or flexibility exercises based on individual results on physical assessment. In addition, participants will be given aerobic exercise goals to achie
The ‘CogStep Phase 2.0’ Intervention will comprise a program of combined home based exercise and psycho-education for a period of 12 weeks. The treatment program comprises two distinct parts: Exercise Prescription: Immediately following the baseline assessments, an Exercise Physiologist will prescribe six individually tailored strength, balance and/or flexibility exercises based on individual results on physical assessment. In addition, participants will be given aerobic exercise goals to achieve each week. The participant will be prescribed exercises and goals tailored to their individual needs encompassing 6 x strength exercises in combination with an aerobic component e.g. walking/jogging (dependent on their ability), with the aim to reach American College of Sport Medicine exercise Guidelines of 150 minutes of moderate exercise per week. This will be outlined with the participant and exercise barriers will be discussed to ensure adherence to the exercises at home. Participants will be provided with an exercise workbook including the prescribed exercises (images demonstrating the exercise, instructions for performing the exercise, options for progression or regression of difficulty, and prescribed volume of exercise), and an exercise tracking sheet for each exercise to monitor compliance. In accordance with standard clinical care, the exercise prescription will be reviewed by an Exercise Physiologist at Week 6 to ensure exercise prescription/intensity is appropriate for the duration of the trial. Psycho-education sessions: Participants will also be given a video CD to take home with a total of 12 sessions, from which participants will be asked to sequentially view one session per week. These will be viewed alongside the implementation of the exercises prescribed. These psycho-education sessions will include 20-30 minute video talks provided by a range of clinicians including Neuropsychologists, Nurses, Clinical Psychologists, Sleep Psychologists, Exercise Physiologists and Nutritionists. Content from the sessions will also be provided in the form of a workbook that will be provided to the participant. This content and the videos have been developed by the Healthy Brain Ageing Program. The sessions include the following content: Session 1: exercise; Session 2: diet; Session 3: brain and cognition; Session 4: memory strategies for ageing individuals; Session 5: managing medications; Session 6: vascular risk factors; Session 7: feeling safe at home in the community; Session 8: anxiety; Session 9: depression and Session 10: sleep. Following the viewing of each session, participants will be encouraged to complete the corresponding activities and/or questions in the provided workbook. Each workbook activity will take participants approximately 10 minutes each week. Participants will be able to clarify any questions during monitoring phone calls at weeks 2, 4 and 9, as well as at the week 6 clinical review. A trained research assistant or other researcher will be asked to administer the monitoring phone calls each week. They will also be asked during this phone call regarding their adherence to the psychoeducation.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Have a The Memory and Ageing Telephone Screen (MATS) score between 13 and 19; • Be greater than 60 years old at time of assessment; • Be willing to attend the baseline (week 1) and follow-up (week 13) assessments at the Brain and Mind centre; • Be willing to undergo Magnetic Resonance Imaging scanning at the Brain and Mind centre; • If randomised to the intervention arm, be willing to view the weekly psychoeducation sessions at home and implement their prescribed exercises at home; and • If randomised to the control arm, be willing to receive health information via text message, email or letter at weeks 2, 4, 6, and 9.
Exclusion criteria
• Have insufficient language skills for neuropsychological assessment; • Have dementia or suspected dementia (MATS <13); • Have history of any other major neurological conditions (e.g., stroke, epilepsy); • Have current severe mood disturbance (K10 score >30); • Have a history of head injury with a loss of consciousness for greater than 30 minutes; • Have a medical condition known to affect cognition (e.g., cancer); • Have a high level of baseline physical activity at study commencement (i.e., meets minimum American College of Sport Medicine exercise guidelines); • Have any exercise contraindications (including unstable angina, uncontrolled cardiac failure, severe aortic stenosis, uncontrolled hypertension, symptomatic hypotension, resting tachycardia or arrhythmia, uncontrolled diabetes or acute illness/fever); • Have any contraindications for magnetic resonance imaging scanning (e.g., aneurysm clip, pacemaker etc); • Have started taking any new medications in the two months prior to commencement of the trial; and/or • Are the current recipient of a cognitive training intervention (therapist or internet-based).
Outcome results
None listed