Category
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Primary study
Registry of Trials»ANZCTR
Year
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2020
INTERVENTION: Physical activity intervention ‐ Participants from the intervention group will undergo 3 months supervised structured physical activity program using the Seniors Exercise Park outdoor equipment followed by a 3 months maintenance phase (unstructured independent exercise). The Seniors Exercise Park ‐ is outdoor playground equipment specifically designed for older people to improve strength, balance, joint movements and mobility and function. It comprises multiple equipment stations that target specific function or movement (upper and lower limb) such as shoulder range of movement, static and dynamic balance (walking on uneven surfaces, walking on a movable bridge), functional movement of walking up/down stairs, sit to stand. Example of the exercises can be found here: https://www.youtube.com/watch?v=PaYuCMtnlYk Structured supervised 12 weeks exercise program: Participants will undergo a 12‐week supervised exercise intervention program twice a week using the seniors exercise park. Participants will perform exercises that focus on strength, balance, coordination, mobility and flexibility. The exercise park sessions will be provided two times a week (each class approximately 1 to 1.5 hours duration) and will be supervised by a qualified physiotherapist or an accredited exercise physiologist with the assistance of another supervisor (Aged Care staff; Physiotherapist/Diversional Therapist). Each session will consist of 5‐7 minutes warm‐up exercises, followed by 45‐75 minutes on the equipment stations, and will conclude with 5‐7 minutes of cool down exercises. The exercise classes will include 3‐4 participants and will be circuit‐based. A familiarisation session will be organised for each participant prior to commencement of the exercise program. The initial l CONDITION: Dementia; ; Dementia Neurological ‐ Dementias Physical Medicine / Rehabilitation ‐ Other physical medicine / rehabilitation PRIMARY OUTCOME: Feasibility including: recruitment and retention (% approached who agreed to participate and % of completion of the intervention); Will be assessed based on review of study record e.g., attendance log [3 months and 6 months] Physical activity program modifications and adaptations (e.g. exercise length, session duration) ‐ will be assessed by review and audit of study record (forms)[3 months and 6 months] Supervision needs (ratio of supervision to participants) ‐ will be assessed by review and audit of study record (forms).[3 months and 6 months] ; Will be assessed based on attendance logs (from the exercise sessions)[Throughout the 6 months exercise program] PRIMARY OUTCOME ‐ Feasibility ‐ safety (combination falls and events as described below) ; Safety will be assessed based on the following: any falls that occur during the exercise delivery sessions, any adverse events (joint/muscle pain during the exercise or as a result of the exercise sessions), serious adverse events (any report of difficulty breathing that does not settle quickly with rest, new or unrelenting chest pain, or acute changes in the level of consciousness during the session where a medical emergency procedure will be required). ; Study record forms (recorded by staff) will be used to collect information around safety.[Throughout the overall 6 months exercise program ] Social isolation and social support will be assessed using the Lubben Social Network Scale[Baseline, 3 months and 6 months] Staff and participants feedback will be collected using a set of questions (survey) [At the completion the 12‐week exercise intervention ] The Falls Risk Assessment Tool (FRAT) will be used to assess fall risk [Baseline, 3 months and 6 months] Wandering behavior (walking off) will be documented by staff (description, duration and time occurred) ; [At each exercise session] SECONDARY OUTCOME: Cognitive function will be assessed using The Montreal Cognitive Assessment (MoCA) [Baseline, 3 months and 6 months] Engagement in the physical and social activity will be assessed using the Group Observational Measurement of Engagement (GOME) tool[At each exercise session] Engagement with daily activity will be assessed by aged care staff using the Pool Activity Level (PAL)[Baseline, 3 months and 6 months] Enjoyment ‐ will be assessed using a five point likert scale enjoyment scale using a visual smiley [At the end of each exercise session ] Fear of falls will be assessed using the Iconographical Falls Efficacy Scale[Baseline, 3 months and 6 months] General motivation and engagement behavior will be assessed using a five‐point Likert scale (from very negative to very positive)[At 5 time points: at the beginning of the structured physical activity program (week 1), half way through (week 6) and at the end (week 12), half way through the maintenance phase (week 18), at the completion of the maintenance phase (week 24). ] Health‐related quality of life will be assessed using the EQ‐5D‐5L. [Baseline, 3 months and 6 months] Health‐related quality of life will be assessed using the Quality of Life in Alzheimer's disease scale (QoL‐AD) [Baseline, 3 months and 6 months] Loneliness will be assessed using the UCLA 3‐Item Loneliness Scale[Baseline, 3 months and 6 months] Mood ‐ will be assessed using a five point likert scale using a visual smiley face card [At the beginning of each exercise session] Motivation to participate will be assessed by the exercise supervisor their observation and interpretation of participants’ expression, verbal prompt and body language using a five point likert scale [At each exercise session ] Physical function measure ‐ Dynamic balance will be assessed using the Step test [Baseline, 3 months and 6 months] Physical function measure ‐ Exercise tolerance and functional mobility will be assessed using the two‐minute walk test [Baseline, 3 months and 6 months] Physical function measure ‐ Functional lower limb muscle strength will be assessed using the five times sit to stand test [Baseline, 3 months, 6 months] Physical function measure ‐ Walking speed will be assessed using the 4 meters walk test [Baseline, 3 months and 6 months] PRIMARY OUTCOME ‐ Feasibility ‐ Attendance and overall adherence (% number of sessions attended relative to total number of available sessions). INCLUSION CRITERIA: Older people will be included in the study if they meet the following inclusion criteria 1) aged 60 years old or over and reside at the aged care facility 2) have been diagnosed with mild to moderate dementia using the Standardised Mini‐Mental State Examination (sMMSE more than 10) 3) are able to stand by themselves with/without hand support; 4) are able to walk without manual (physical) assistance from staff and 5) who are able to follow simple exercise instructions.
Epistemonikos ID: 1e08a2f5390bb69aee72eac06854356233366044
First added on: Aug 24, 2024