NCT07506278

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: National Geriatric Hospital · Other Government
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• Fraity Syndrome
• Exercise Intervention

Interventions

Type	Name	Description
BEHAVIORAL	Vivifrail 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

Timeline

• Start date: 2024-09-13
• Primary completion: 2025-07-28
• Completion: 2026-01-30
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: Vietnam