Type 2 DiabetesNCT06462534
The Band-Frail Study: A Provincial Intervention to Outweigh Diabetes and Frailty in New Brunswick
A study testing Band-Frail Program in people with Type 2 Diabetes and Frailty, run by University of New Brunswick at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes, Frailty
- What is being tested?
- Band-Frail Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of New Brunswick- Faculty of Kinesiology
Fredericton, New Brunswick, E3B5A3
About this study
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.
Read the 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
- Being tested
- Band-Frail Program
- Keywords
- elastic band resistance training, exercise intervention, aging, community intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Band-Frail ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Band-Frail Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (1)
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).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Mar 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Responsible party
- Principal investigator, Martin Senechal, University of New Brunswick
- Investigators
- Martin Senechal, PhD, Principal investigator, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462534
- Sponsor's protocol ID
- 2020-029
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Band-Frail Study: A Provincial Intervention to Outweigh Diabetes and Frailty in New Brunswick
- ClinicalTrials.gov ID
- NCT06462534
- Acronym / sponsor ID
- 2020-029
- Conditions
- Type 2 Diabetes, Frailty
- Keywords
- elastic band resistance training, exercise intervention, aging, community intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Band-Frail Intervention | Experimental | Behavioral: Band-Frail ProgramIndividuals 65 years or older living with T2D and frailty will participate in elastic band resistance training and diabetes education sessions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Band-Frail ProgramParticipants 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. | Behavioural | Band-Frail Intervention |
Primary outcome
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.
1 secondary outcome
Frailty Status
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Senechal, PhD principal investigator
University of New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Band-Frail Program in people with Type 2 Diabetes and Frailty, run by University of New Brunswick at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Functioning (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.