Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 Exercise | Behavioral: CrossFit group exercise classes | Not Applicable |
The Canadian Diabetes Association 2018 Clinical Practice Guidelines state that moderate to high levels of physical activity and cardiorespiratory fitness are associated with substantially lower morbidity and mortality in people with diabetes. The recommendations include a combination of aerobic, resistance, and flexibility exercises. The Guidelines specifically advocate for strategies that increase self-efficacy and motivation in order to increase physical activity uptake and maintenance.
Similarly, the importance of exercise counselling in primary care is widely recognized. Exercise is frequently identified as a key intervention for many chronic conditions, yet it remains under-prescribed. Physical activity counselling during routine diabetes care often takes a back seat to other issues, or lacks specific, actionable details that are important for patients to successfully integrate regular physical activity into their lifestyle. Moreover, even when prescribed, the successful implementation of physical activity behaviour changes remains a challenge for patients.
Eligible Rosemount Family Health Organization adult patients age >=18 years with type 2 diabetes mellitus will receive an email or mail invitation to self-refer to a structured, facility-based, supervised aerobic and resistance exercise program. Interested patients will be invited to attend a 1-hour information session at the exercise facility at the time of implementation start up where they will complete an initial survey. Patients will then be free to attend up to 6 regularly-scheduled, group, free classes per week at a local exercise facility for a period of 3-months. Classes will be supervised by experienced trainers.
Measures of program success will focus around four themes, informed in part by the Institute for Healthcare Improvement's Triple Aim: (i) adherence to CDA guidelines for physical activity, (ii) patient experience, and (iii) health impact. Our balancing measure will be potential costs incurred by patients. Adherence measures, including percentage uptake (i.e. attend introductory session and one class), retention (at 1, 2 and 3-months), and percentage who meet CDA recommendations for exercise will be collected. Reasons for declined or discontinued participation will also be collected voluntarily from patients to help identify concrete or perceived barriers to structured exercise programs. Health-related measures will include quality of life (EQ-5D-5L) and exercise self-efficacy (Basic Psychological Needs in Exercise Scale, BP-NES). These will be measured by patient-report at 0, 1, 2, and 3-months. Participants will be asked to rate their "willingness to recommend" (Likert scale 1-10) the program to other individuals with T2DM. Additionally, pre- and post-exercise program hemoglobin A1c and blood pressure measurements (both of which are routinely collected for all patients with T2DM) will be obtained from patient charts. Finally, while this program will be free to patients, a hypothetical cost per patient will be estimated in order to gain an understanding of the financial costs compared to the value added through patient experience and health outcome measures.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Implementation of a Multi-component, Supervised Exercise Program for Patients With Type 2 Diabetes Mellitus From a Primary Care Practice: A Quality Improvement Study. |
Estimated Study Start Date : | September 2019 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | February 2020 |
Arm | Intervention/treatment |
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Self-referral to group exercise classes
Structured, multi-component, supervised group exercise classes are the health related intervention proposed for this study. The group classes will occur at a local CrossFit gym facility. For the purposes of this project, all eligible Rosemount Clinic patients with type 2 diabetes mellitus will receive an email or letter mail invitation to self-refer to a structured, facility-based, supervised aerobic and resistance exercise program. Interested patients will be invited to attend a 1-hour information session at the exercise facility at the time of implementation start up where they will complete an initial baseline survey. This session will also serve as an initial meet and greet for participants to meet exercise trainers prior to starting exercise classes and to receive a tour of the facility. |
Behavioral: CrossFit group exercise classes
The group classes will occur at a local CrossFit gym facility. Participants will be free to attend up to 6 regularly-scheduled, free, 1-hr group classes per week at the local exercise facility for a period of 3-months. The recommendation will be to aim to attend at least three classes/week but there will no prescribed minimum. Classes will be supervised by experienced trainers. Trainers will work collaboratively with participants to adapt the skill and workout of the day within each group class to the individual participant's physical limitations and needs. As such, each participant may complete a slightly different movement or workout on any given day based on their functional status at that time. However, all participants will be actively included in the community of the group class and will experience a relative stimulus that is moderately challenging for them. |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria are primarily based off of those employed in the Look AHEAD (Action for Health in Diabetes) trial. The Look AHEAD trial is the largest randomized trial to date evaluating the efficacy of a physical activity and dietary control intervention in older adults with type 2 diabetes (Espeland, M. et al. 2003. Look AHEAD [Action for Health in Diabetes]: design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes. Controlled Clinical Trials. 24:610-628.).
Contact: Jennifer Crichton, MD | 6132744851 | jcrichton@qmed.ca |
Tracking Information | |||||
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First Submitted Date ICMJE | July 5, 2019 | ||||
First Posted Date ICMJE | July 24, 2019 | ||||
Last Update Posted Date | September 6, 2019 | ||||
Estimated Study Start Date ICMJE | September 2019 | ||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Implementation of a Multi-component, Supervised Exercise Program for Patients With Type 2 Diabetes Mellitus. | ||||
Official Title ICMJE | Implementation of a Multi-component, Supervised Exercise Program for Patients With Type 2 Diabetes Mellitus From a Primary Care Practice: A Quality Improvement Study. | ||||
Brief Summary | This quality improvement study aims to implement a supervised, multi-component exercise program for patients type 2 diabetes mellitus (T2DM) from a primary care practice. Rosemount Clinic patients with T2DM will be invited to participate in free group exercise classes as part of a 3-month program of structured exercise to enhance adherence to the Canadian Diabetes Association (CDA) clinical best practice guidelines. Interested patients will attend an initial 1-hour information session and then will complete short, monthly questionnaires about their current quality of life and experience with the exercise program. Participation is voluntary and patients may drop out at any time. | ||||
Detailed Description |
The Canadian Diabetes Association 2018 Clinical Practice Guidelines state that moderate to high levels of physical activity and cardiorespiratory fitness are associated with substantially lower morbidity and mortality in people with diabetes. The recommendations include a combination of aerobic, resistance, and flexibility exercises. The Guidelines specifically advocate for strategies that increase self-efficacy and motivation in order to increase physical activity uptake and maintenance. Similarly, the importance of exercise counselling in primary care is widely recognized. Exercise is frequently identified as a key intervention for many chronic conditions, yet it remains under-prescribed. Physical activity counselling during routine diabetes care often takes a back seat to other issues, or lacks specific, actionable details that are important for patients to successfully integrate regular physical activity into their lifestyle. Moreover, even when prescribed, the successful implementation of physical activity behaviour changes remains a challenge for patients. Eligible Rosemount Family Health Organization adult patients age >=18 years with type 2 diabetes mellitus will receive an email or mail invitation to self-refer to a structured, facility-based, supervised aerobic and resistance exercise program. Interested patients will be invited to attend a 1-hour information session at the exercise facility at the time of implementation start up where they will complete an initial survey. Patients will then be free to attend up to 6 regularly-scheduled, group, free classes per week at a local exercise facility for a period of 3-months. Classes will be supervised by experienced trainers. Measures of program success will focus around four themes, informed in part by the Institute for Healthcare Improvement's Triple Aim: (i) adherence to CDA guidelines for physical activity, (ii) patient experience, and (iii) health impact. Our balancing measure will be potential costs incurred by patients. Adherence measures, including percentage uptake (i.e. attend introductory session and one class), retention (at 1, 2 and 3-months), and percentage who meet CDA recommendations for exercise will be collected. Reasons for declined or discontinued participation will also be collected voluntarily from patients to help identify concrete or perceived barriers to structured exercise programs. Health-related measures will include quality of life (EQ-5D-5L) and exercise self-efficacy (Basic Psychological Needs in Exercise Scale, BP-NES). These will be measured by patient-report at 0, 1, 2, and 3-months. Participants will be asked to rate their "willingness to recommend" (Likert scale 1-10) the program to other individuals with T2DM. Additionally, pre- and post-exercise program hemoglobin A1c and blood pressure measurements (both of which are routinely collected for all patients with T2DM) will be obtained from patient charts. Finally, while this program will be free to patients, a hypothetical cost per patient will be estimated in order to gain an understanding of the financial costs compared to the value added through patient experience and health outcome measures. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: CrossFit group exercise classes
The group classes will occur at a local CrossFit gym facility. Participants will be free to attend up to 6 regularly-scheduled, free, 1-hr group classes per week at the local exercise facility for a period of 3-months. The recommendation will be to aim to attend at least three classes/week but there will no prescribed minimum. Classes will be supervised by experienced trainers. Trainers will work collaboratively with participants to adapt the skill and workout of the day within each group class to the individual participant's physical limitations and needs. As such, each participant may complete a slightly different movement or workout on any given day based on their functional status at that time. However, all participants will be actively included in the community of the group class and will experience a relative stimulus that is moderately challenging for them. |
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Study Arms ICMJE | Self-referral to group exercise classes
Structured, multi-component, supervised group exercise classes are the health related intervention proposed for this study. The group classes will occur at a local CrossFit gym facility. For the purposes of this project, all eligible Rosemount Clinic patients with type 2 diabetes mellitus will receive an email or letter mail invitation to self-refer to a structured, facility-based, supervised aerobic and resistance exercise program. Interested patients will be invited to attend a 1-hour information session at the exercise facility at the time of implementation start up where they will complete an initial baseline survey. This session will also serve as an initial meet and greet for participants to meet exercise trainers prior to starting exercise classes and to receive a tour of the facility. Intervention: Behavioral: CrossFit group exercise classes
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | February 2020 | ||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: Exclusion criteria are primarily based off of those employed in the Look AHEAD (Action for Health in Diabetes) trial. The Look AHEAD trial is the largest randomized trial to date evaluating the efficacy of a physical activity and dietary control intervention in older adults with type 2 diabetes (Espeland, M. et al. 2003. Look AHEAD [Action for Health in Diabetes]: design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes. Controlled Clinical Trials. 24:610-628.).
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04030364 | ||||
Other Study ID Numbers ICMJE | 20190116-01H | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Ottawa Hospital Research Institute | ||||
Study Sponsor ICMJE | Ottawa Hospital Research Institute | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Ottawa Hospital Research Institute | ||||
Verification Date | September 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |