A randomized controlled clinical trial that will test how physical exercise will impact outcomes of functional ability, cognitive function and quality of life in older patients with type 2 diabetes who have been diagnosed as Fraity syndrome. The intervention will be 6 months in duration with approximately 72 sessions of exercises. Outcome measures will be collected at baseline, 3 months and 6 months.
Fraity syndrome, prevalent among geriatric populations, is associated with higher susceptibility to falls, comorbidities, and mortality. Multidomain interventions have been shown to be effective in improving quality of life and delaying progression of functional impairment or disability in older adults. Specially, VIVIFRAIL was developed by world experts in the field of physical exercise and frailty, and is considered an important step towards the novel era of precise prescription of physical activity. Nevertheless, the effect of physical exercise as a systematic, structured and repetitive type of physical activity, in the reduction of risk of cognitive decline in the elderly, is not very clear.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Vivifrail exercise programme includes face-to-face education on Multi-component Physical training: A Program for patients with moderate limitation with EXERCISE WHEEL include 7 exercises for 1 course. During the first 8 weeks, the patient exercises 3 times/week with a level of exertion according to Borg's category-ratio 10 (CR10) scale of 4-5 points. For the next 8 weeks, the patient exercises 3 times/week with Borg's CR10 exertion level of 6-7 points. In the last 8 weeks, the patient exercises 3 times/week with Borg's CR10 exertion level of 8-9 points. The six-month intervention involves twenty-four weekly calls, with a focus on building rapport (e.g. providing feedback on the baseline assessment); education reinforcement on resistance training; and skill-building (e.g. self-monitoring and resistance training diary). The emphasis is on helping participants to gain the knowledge and skills necessary to achieve targeted intensity. Every 4 weeks, all patients are re-visite
Phu Tho Province General Hospital
Viet Tri, Phu Tho, Vietnam
Physical performance 1 - Handgrip strength
Handgrip strength is assessed using a hand dynamometer named Jamar Hydraulic Hand Dynamometer: the higher number the better outcome.
Time frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
Physical performance 2 - Gait speed
4-metre gait speed test (the shorter time the better outcome)
Time frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
Physical performance 3 - Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery developed by the National Institute on Aging: scores ranging from 0 (worst) to 12 (best)
Time frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
Nutritional status
Nutritional status is assessed using the Mini Nutritional Assessment Short-Form (MNA-SF): scores ranging from 0 (worst) to 14 (best)
Time frame: Prior to the start of intervention,3 months and 6 months (completion of the intervention)
Activities of Daily Living (ADLs)
Katz Index of Independence in Activities of Daily Living (scores range from 0-worst to 6-best)
Time frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
The Mini-Cog Score
The Mini-Cog Score uses a three-item recall for memory and intuitive clock-drawing test to screen a dementia (scores range from 0-worst to 5-best)
Time frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
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21-item Fall Risk Index questionnaire
The 21-item Fall Risk Index (FRI-21) has been used to detect elderly persons at risk for falls: scores ranging from 0 (best) to 21 (worst)
Time frame: Prior to the start of intervention,3 months and 6 months (completion of the intervention)
Instrumental Activities of Daily Living (IADLs)
Lawton Instrumental Activities of Daily Living Scale (scores range from 0-low function \& dependent to 8-high function \& independent for women, and 0-worst to 5-best for men)
Time frame: First visit, 3 months, 6 months