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Clinical Trials/NCT06462534
NCT06462534
Completed
Not Applicable

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

University of New Brunswick1 site in 1 country203 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
University of New Brunswick
Enrollment
203
Locations
1
Primary Endpoint
Physical Functioning
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
December 31, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martin Senechal

Full Professor, Martin Senechal, Ph.D.

University of New Brunswick

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Physical Functioning

Time Frame: 16 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 Outcomes

  • Frailty Status(16 weeks)

Study Sites (1)

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