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

NCT ID: NCT06462534

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-12-31

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.

Conditions

Type 2 Diabetes; Frailty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Band-Frail Intervention

Individuals 65 years or older living with T2D and frailty will participate in elastic band resistance training and diabetes education sessions.

Group Type: EXPERIMENTAL

Band-Frail Program

Intervention Type: BEHAVIORAL

Participants will complete 16 weeks of elastic band resistance training and diabetes management education.

Exercise Component:

The elastic band resistance training involves 12 exercises: chair sit-to-stands, seated chest press, seater upper back reverse fly, seated single arm row, seated single arm lateral raise, seated single arm bicep curl, seated single arm triceps extension, seated single leg quadriceps extension, standing hamstring curl, standing leg extension, and seated abdominal crunches.

There will be a one-minute rest between each set and a self-determined rest period between exercises.

Education Component:

A certified Diabetes Educator and registered dietitian will present information to participants covering topics relating to T2D management and nutritional information.

Interventions

Band-Frail Program

Participants will complete 16 weeks of elastic band resistance training and diabetes management education.

Exercise Component:

The elastic band resistance training involves 12 exercises: chair sit-to-stands, seated chest press, seater upper back reverse fly, seated single arm row, seated single arm lateral raise, seated single arm bicep curl, seated single arm triceps extension, seated single leg quadriceps extension, standing hamstring curl, standing leg extension, and seated abdominal crunches.

There will be a one-minute rest between each set and a self-determined rest period between exercises.

Education Component:

A certified Diabetes Educator and registered dietitian will present information to participants covering topics relating to T2D management and nutritional information.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role: collaborator

University of New Brunswick

OTHER

Sponsor Role: lead

Responsible Party

Martin Senechal

Full Professor, Martin Senechal, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Senechal, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New Brunswick

Locations

University of New Brunswick- Faculty of Kinesiology

Fredericton, New Brunswick, Canada

Countries

Canada

Other Identifiers

2020-029

Identifier Type: -

Identifier Source: org_study_id