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Completed

NCT Number: NCT07506278

Results Of Vivifrail Exercise In Older Type 2 Diabetic Patients With Fraity Syndrome

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Exercise Intervention Fraity Syndrome Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phu Tho Province General Hospital

Viet Tri, Phu Tho, 35100, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vivifrail Exercise Programme Training

Behavioral

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

Primary outcomes

  1. Physical performance 1 - Handgrip strength

    Time frame: 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.

  2. Physical performance 2 - Gait speed

    Time frame: 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)

  3. Physical performance 3 - Short Physical Performance Battery (SPPB)

    Time frame: 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 outcomes

  1. Nutritional status

    Time frame: 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)

  2. Activities of Daily Living (ADLs)

    Time frame: 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)

  3. The Mini-Cog Score

    Time frame: 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)

  4. 21-item Fall Risk Index questionnaire

    Time frame: 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)

  5. Instrumental Activities of Daily Living (IADLs)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

National Geriatric Hospital

Other Gov

Registry information

Official study title

Evaluating The Effect Of Fraity Intervention In Older Adults With Typ 2 Diabetes Using Exercise

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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