Clinical trial NCT06462534: The Band-Frail Study: A Provincial Intervention to Outweigh Diabetes and Frailty in New Brunswick
Official title: The Band-Frail Study: A Provincial Intervention to Outweigh Diabetes and Frailty in New Brunswick
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Frailty
Keywords: elastic band resistance training
exercise intervention
aging
community intervention
Lead sponsor: University of New Brunswick
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2024-06-17
Enrollment: 203
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Physical Functioning
timeFrame: 16 weeks
Secondary outcomes:
measure: Frailty Status
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Fredericton
country: Canada
facility: University of New Brunswick- Faculty of Kinesiology
state: New Brunswick
Study officials:
affiliation: University of New Brunswick
name: Martin Senechal, PhD
role: PRINCIPAL_INVESTIGATOR
References: