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The Band-Frail Study: A Provincial Intervention to Outweigh Diabetes and Frailty in New Brunswick

Not Applicable
Completed
Conditions
Frailty
Type 2 Diabetes
Interventions
Behavioral: Band-Frail Program
Registration Number
NCT06462534
Lead Sponsor
University of New Brunswick
Brief Summary

The goal of this study is to test whether psychological, social, and physical health outcomes of older adults living with type 2 diabetes and frailty are improved when participating in the Band-Frail Program.

Detailed Description

Individuals considered fragile or frail and living with type 2 diabetes (T2D) have a 5-fold increased risk of being moved to a long-term care facility and a 4-fold increased risk of an emergency department visit. In 2013, the Mid-Frail study found that 16 weeks of combined exercise, diet, and education intervention significantly improved functional abilities in older adults living with T2D and frailty.

The goal of The Band-Frail Study is to implement an adapted version of the Mid-Frail program in New Brunswick (NB), while ensuring its sustainability by leveraging existing resources in the future as NB has one of the highest rates of diabetes in Canada and one of the highest average age of residents.

This project will include adults aged 65 years and above living with T2D and frailty across the province of New Brunswick (NB). Participants will meet in groups of 4-8 people twice a week for 16 weeks. One session will consist of diabetes management education delivered by a Certified Diabetes Educator and elastic band resistance training, while the second session will only involve the elastic band resistance training.

Participants will undergo pre- and post-testing including questionnaires, physical function tests, and interviews to assess the viability of this program in the province and determine the physical and psychological benefits.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
203
Inclusion Criteria
  • Aged over 65 years old
  • Classified as frail or pre-frail on Fried's Frailty Scale
  • Self-reported diagnosis of type 2 diabetes
  • Not physically active (3+ days of physical activity per week)
Exclusion Criteria
  • Aged under 65 years old
  • Classified as robust of Fried's Frailty Scale
  • Not diagnosed with type 2 diabetes
  • Regularly physically active (3+ days of physical activity per week)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Band-Frail InterventionBand-Frail ProgramIndividuals 65 years or older living with T2D and frailty will participate in elastic band resistance training and diabetes education sessions.
Primary Outcome Measures
NameTimeMethod
Physical Functioning16 weeks

Physical functioning will be measured using the Short Physical Performance Battery (SPPB). The SPPB is a three-part standardized test including balance, gait, and chair stand components each scored out of 4 points for a total possible score ranging from 0 to 12 points. A higher SPPB score suggests high levels of physical functioning, while a lower SPPB score suggests functional limitations.

Secondary Outcome Measures
NameTimeMethod
Frailty Status16 weeks

Frailty status will be measured using Fried's Frailty Scale. The scale includes five frailty criteria: unintentional weight loss, exhaustion, low physical activity, slowness, and weak grip strength.

Participants will be scored in each of the five criteria and then given a cumulative score ranging from 0 to 5 to represent their frailty status. Participants who score three or more criteria will be considered frail, individuals who score one or two criteria will be considered pre-frail, and those who score zero criteria will be considered robust (non-frail).

Trial Locations

Locations (1)

University of New Brunswick- Faculty of Kinesiology

🇨🇦

Fredericton, New Brunswick, Canada

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