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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06462534
• Other study ID #: 2020-029
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2024
• Source: University of New Brunswick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Frailty
• Type 2 Diabetes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	University of New Brunswick- Faculty of Kinesiology	Fredericton	New Brunswick

Sponsors (2)

Lead Sponsor	Collaborator
University of New Brunswick	Public Health Agency of Canada (PHAC)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Functioning	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.	16 weeks
Secondary	Frailty Status	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).	16 weeks