Authors
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Rosendahl, Erik -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2011
INTERVENTION: Exercise intervention: The exercise intervention is based on the High‐Intensity Functional Exercise Program (the HIFE Program). The program includes functional exercises consisting of everyday tasks challenging leg strength, postural stability, and gait ability. The physiotherapists select exercises for each participant according to their functional deficits. All exercises are performed in weight‐bearing positions, eg squats, turning trunk and head while standing, and walking over obstacles. The participants are encouraged by the physiotherapists to exercise with a high intensity and to increase load and difficulty progressively, considering changes in function and health status. Strength exercises are intended to be performed at 8?12 repetition maximum. Balance exercises are intended to challenge the participant?s postural stability fully. Control activity: The control activity program includes activities while sitting. The program is based on themes, e.g. birds, famous persons, and seasons, and is expected to be interesting and stimulating for older persons with dementia. Procedure: The exercise intervention and the control activity starts in October 2011, and are performed in groups of three to eight participants supervised by two Physiotherapists (exercise) and one Occupational Therapist or Occupational Therapy Assistant (control). The sessions last approximately 45 minutes and are held five times every two weeks for four months (16.5 weeks), a total of 40 sessions. After each session the supervisors will register attendance, adverse events, and for the exercise group, the intensity achieved, in a structured report. CONDITION: Dementia disorders ; Mental and Behavioural Disorders ; Dementia PRIMARY OUTCOME: Dependence in personal activities of daily living (ADL) using the Functional Independence Measurement (FIM) and the Barthel ADL Index, at 4 (end of intervention period) and 7 months (follow‐up 3 months after the intervention period), respectively. SECONDARY OUTCOME: 1. Balance using Berg Balance Scale (BBS), at 4 and 7 months, respectively. ; 2. Mobility using self‐paced timed walk (forward and backward, with and without ordinary walking aid if any) and the Chair‐stand test, at 4 and 7 months, respectively; 3. Cognitive functions using the Alzheimer?s Disease Assessment Scale‐Cognitive Subscale (ADAS‐Cog), verbal fluency, and Mini‐Mental State Examination (MMSE), at 4 and 7 months, respectively.; 4. Incidence of falls reported prospectively by staff and analysed at 6 and 12 months, respectively, from the end of intervention period.; 5. Behaviour and psychological symptoms of dementia (BPSD) using the Neuropsychiatric Inventory (NPI) and delirium using the Organic Brain Syndrome (OBS) scale, at 4 and 7 months, respectively.; 6. Attendance, adverse events and, for the exercise group, intensity achieved, using a structured report completed by the supervisors after each session.; 7. Participants experiences of participating in the exercise, by an interview; 8. Depressive symptoms using Geriatric Depression Scale (GDS‐15) and Montgomery Åsberg Depression Rating Scale (MADRS), at 4 and 7 months, respectively.; 9. Psychological wellbeing using Philadelphia Geriatric Centre Morale Scale (PGCMS) and experienced loneliness, at 4 and 7 months, respectively.; 10. Mortality, diseases, and hospital admission, by reviewing participants? hospital records and death certificates for 12 months from the end of the intervention; 11. Analyses of the levels of parathyroid hormone (PTH) and levels of vitamin D of the effect on ADL, falls, and physical and cognitive functions. ; 12. Explanatory analyses of the effect on ADL. Independent variables: FIM, Barthel ADL Index, MMSE, Mini Nutritional Assessment, BBS, depression, type of dementia disorder, drugs, age, sex, self‐perceived health.; 13. Sub‐group analyses of the effect on falls among people able to independently rise up from a chair. INCLUSION CRITERIA: 1. Diagnosed dementia disorder and living in residential care facilities 2. Age 65 or over 3. Dependent on assistance from a person in one or more personal activities of daily living according to the Katz Index 4. Able to stand up from a chair with armrests with help from no more than one person 5. A Mini‐Mental State Examination (MMSE) score of 10 or more 6. An approval from the resident?s physician 7. Able to hear sufficiently well to participate in the assessments 8. Able to understand Swedish language sufficiently well to participate in the assessments
Epistemonikos ID: cb3c050981a13a0d9e06f1c419fb8047401e3b1f
First added on: Aug 22, 2024