Category
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Primary study
Registry of Trials»ANZCTR
Year
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2019
INTERVENTION: For the DAMPAA group (name of intervention group) a group centre‐based balance, strengthening and moderate level exercise program will be delivered twice a week for 6 months following intervention protocol, with home/community based exercise to be completed 1 day a week. Group sessions (10 ‐15 participants) will be delivered primarily at the 3 Aboriginal Community Controlled Health Services sites by exercise physiologists or physiotherapists and Aboriginal health workers (Aboriginal care coordinators), with home programs tailored to participants’ needs. The target exercise program will consist of 3 x 50 minutes of moderate level exercise per week (such as brisk walking) and standing balance and strengthening items. Exercise intensity will be monitored with heart rate monitors during the sessions. Home‐based exercise compliance will be monitored by asking participants to self‐rate on a visual scale. Both exercise programs will be progressive in terms of duration of the sessions and the intensity of the exercise over the first 8 weeks until the target exercise is reached. The home‐based program will be a continuation of the program devised by the exercise physiologist/physiotherapist for the centre‐based program. The weekly home‐based session will be a repeat of the centre‐based session with the balance and strengthening exercises prescribed by the exercise physiologist/physiotherapist based on the individual's exercise capacity, mobility and fitness needs. The main exercise component of aerobic or circuit work will also be selected based on the individual's exercise needs and for the home‐based program availability of space and community programs. Progress on both centre and home‐based programs will be monitored (as above) and by written and verbal reports from the participants at the centre‐based sessions and the text replies for the home‐based sessions. The individual’s programs will revised weekly by the exercise physiologist/physiotherapist with any necessary CONDITION: Cardiovascular ‐ Other cardiovascular diseases dementia ;cognitive impairment not dementia;cardiovascular risk factors;functional impairment;falls; ; dementia; ; cognitive impairment not dementia ; cardiovascular risk factors ; functional impairment ; falls Injuries and Accidents ‐ Other injuries and accidents Neurological ‐ Dementias PRIMARY OUTCOME: Cognitive decline measured by the KICA‐Cog assessment (Kimberley Indigenous Cognitive Assessment)[Baseline; 6 months, 12 months and 18 months (primary timepoint) after intervention commencement] Daily function measured by the KICA‐ADL (Kimberley Indigenous Cognitive Assessment Activities of Daily Life questionnaire), or death recorded through hospital linkage data and through follow up with next of kin.[Baseline; 6 months, 12 months and 18 months (primary timepoint) after intervention commencement] Quality of life; measured using the Good Spirit Good Life questionnaire and EQ5D5L tool.[Baseline; 6 months, 12 months and 18 months (primary timepoint) after intervention commencement] SECONDARY OUTCOME: Anxiety and depression status via GAD7 and KICA questionnaires.[Baseline; 6 months, 12 months and 18 months after intervention commencement] Blood glucose control measured as glycated haemoglobin (HbA1c) from fasted blood test[Baseline; 6 months, 12 months and 18 months after intervention commencement] Body weight and body composition using bioimpedance scales[Baseline; 6 months, 12 months and 18 months after intervention commencement] Change in blood lipids (cholesterol, triglycerides) reflecting cardiovascular risk ‐ via fasted blood test[Baseline; 6 months, 12 months and 18 months after intervention commencement] Change in blood pressure ‐ using an automatic blood pressure monitor ; [Baseline; 6 months, 12 months and 18 months after intervention commencement] Cognitive performance measured by Colour Trails test, [Baseline; 6 months, 12 months and 18 months after intervention commencement] Cognitive performance measured by Symbol Digit Modalities test, [Baseline; 6 months, 12 months and 18 months after intervention commencement] Cognitive performance measured via Hopkins Verbal Learning Test,[Baseline; 6 months, 12 months and 18 months after intervention commencement] Functional capacity through step test for balance (Hill, 1996); 2 minute walk, sit‐to‐stand and Timed Up and Go test scores [Baseline; 6 months, 12 months and 18 months after intervention commencement] Health Economic Costing through health data linkage and documentation of resources used throughout the study[18 months after randomisation] Kidney function measured as eGFR and albumin from fasted blood test[Baseline; 6 months, 12 months and 18 months after intervention commencement] Number of falls in last 6 months, measured through questionnaire (Falls Risk in Older People ‐ Community (FROP‐Com) screening tool)[Baseline; 6 months, 12 months and 18 months after intervention commencement] Regular physical activity levels through RAPA questionnaire (Rapid Assessment of Physical Activity)[Baseline; 6 months, 12 months and 18 months after intervention commencement] Smoking status and alcohol intake from KICA smoking and alcohol questionnaires[Baseline; 6 months, 12 months and 18 months after intervention commencement] Waist and hip girths measured with constant tension tape[Baseline; 6 months, 12 months and 18 months after intervention commencement] INCLUSION CRITERIA: 1) Aboriginal Australian and/or Torres Strait Islander 2) aged between 45 and 90 years; 3) community dwelling; 4) cognitive impairment with no dementia (defined by score of 32‐36 out of 39 on KICA Cog, and no functional decline due to cognitive impairment).
Epistemonikos ID: c72a2c65d5dff9e9682e6d80988be13da97825b3
First added on: Aug 24, 2024