Exercise Intervention, Fraity Syndrome, Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Fraity syndrome, Exercise intervention, Vivifrail exercise programme, Fall Risk
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVivifrail Exercise Programme Training
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
Sponsors
National Geriatric Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetic patients diagnosed using American Diabetes Association 2022 criteria * HbA1c ≥ 6.5 and ≤ 9.0% * Frailty diagnosed using criteria from the The Fried frailty phenotype (FP) * Age ≥ 60 and ≤ 80
Exclusion criteria
* Acute diabetic complications * Patients are in the acute phase of musculoskeletal disorders: acute gout, progressing low-grade arthritis, acute joint pain due to joint degeneration, sciatic pain, and infectious arthritis. * Patients suffer from conditions significantly affecting cognition and mobility: sequelae of stroke (with weakness, limb paralysis), muscular weakness, limb disabilities, severe heart failure, severe cognitive decline, and psychiatric disorders. * Patients have been bedridden due to illness for more than 1 month within the past 3 months up to the recruitment time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance 1 - Handgrip strength | Prior to the start of intervention, 3 months and 6 months (completion of the intervention) | Handgrip strength is assessed using a hand dynamometer named Jamar Hydraulic Hand Dynamometer: the higher number the better outcome. |
| Physical performance 2 - Gait speed | Prior to the start of intervention, 3 months and 6 months (completion of the intervention) | 4-metre gait speed test (the shorter time the better outcome) |
| Physical performance 3 - Short Physical Performance Battery (SPPB) | Prior to the start of intervention, 3 months and 6 months (completion of the intervention) | The Short Physical Performance Battery developed by the National Institute on Aging: scores ranging from 0 (worst) to 12 (best) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status | Prior to the start of intervention,3 months and 6 months (completion of the intervention) | Nutritional status is assessed using the Mini Nutritional Assessment Short-Form (MNA-SF): scores ranging from 0 (worst) to 14 (best) |
| Activities of Daily Living (ADLs) | Prior to the start of intervention, 3 months and 6 months (completion of the intervention) | Katz Index of Independence in Activities of Daily Living (scores range from 0-worst to 6-best) |
| The Mini-Cog Score | Prior to the start of intervention, 3 months and 6 months (completion of the intervention) | 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) |
| 21-item Fall Risk Index questionnaire | Prior to the start of intervention,3 months and 6 months (completion of the intervention) | 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) |
| Instrumental Activities of Daily Living (IADLs) | First visit, 3 months, 6 months | 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) |
Countries
Vietnam
Contacts
STUDY_DIRECTORNgan Thi Kim Duong, Master
Phu Tho Province General Hospital
Outcome results
None listed