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

NCT06462534 | Completed

• 1 other identifier: 2020-029
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Frailty

Keywords

elastic band resistance training; exercise intervention; aging; community intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frailty Status

  16 weeks

Study Arms (1)

Band-Frail Intervention

EXPERIMENTAL

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

Behavioral: Band-Frail Program

Interventions

Band-Frail Program 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.

Band-Frail Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of New Brunswick: lead
• Public Health Agency of Canada (PHAC): collaborator

Study Sites (1)

University of New Brunswick- Faculty of Kinesiology

Fredericton, New Brunswick, E3B5A3, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Frailty

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Senechal, PhD

  University of New Brunswick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Martin Senechal, Ph.D.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: March 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CA (1)