4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Implementation of a Multi-component, Supervised Exercise Program for Patients With Type 2 Diabetes Mellitus.

Implementation of a Multi-component, Supervised Exercise Program for Patients With Type 2 Diabetes Mellitus.

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Exercise Behavioral: CrossFit group exercise classes Not Applicable

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.

Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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.


Outcome Measures
Primary Outcome Measures :
  1. Program adherence [ Time Frame: 3-months ]
    Percentage of participants who meet or exceed Canadian Diabetes Association guideline recommendations for exercise in type 2 diabetes

  2. Program uptake [ Time Frame: 3-months ]
    Percentage of participants who attend the introductory session and at least one group class

  3. Program retention [ Time Frame: 3-months ]
    Retention rate of participants


Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 0, 1, 2 and 3-months ]
    Change from baseline in 5-level EuroQol-5 Domain score (this is a quality of life scale where higher values indicate better quality of life) with Canadian index scores ranging from -0.148 (worst state) to 0.949 (best state).

  2. Psychological experience with exercise [ Time Frame: 0, 1, 2 and 3-months ]
    Change from baseline in Basic Psychological Needs in Exercise Scale (measuring basic psychological needs in healthy physical exercise) score with scores ranging from 11 (worst) to 55 (best) (in other words higher scores indicate that needs are better met).

  3. Willingness to recommend [ Time Frame: 3-months ]
    Participants will be asked to rate their "willingness to recommend" (Likert scale) the program to other individuals with type 2 diabetes (this is a 10-point scale where higher values indicate higher likelihood to recommend).

  4. Blood pressure [ Time Frame: 0 and 3-months ]
    Baseline and post-intervention blood pressure measurements will be obtained from patient charts, as routinely collected during type 2 diabetes care every 3-months.

  5. Hemoglobin A1c [ Time Frame: 0 and 3-months ]
    Baseline and post-intervention hemoglobin A1c measurements will be obtained from patient charts, as routinely collected during type 2 diabetes care every 3-months.

  6. Hypothetical program cost per patient [ Time Frame: 3-months ]
    A hypothetical program cost per patient will be estimated to balance against the program benefits.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult (age >= 18 years) patients rostered with one of the Rosemount Clinic physicians with a clinical diagnosis of type 2 diabetes mellitus (fasting plasma glucose of >= 7.0 mmol/L, a 2-hour plasma glucose value in a 75 g oral glucose tolerance test of >= 11.1 mmol/L or a glycated hemoglobin (A1C) of >= 6.5%).

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.).

  • Pregnant
  • A1C > 11%
  • Blood pressure >= 160/100 mmHg
  • Fasting triglycerides >= 600 mg/dL
  • Underlying diseases that may limit life span and/or affect the safety of the intervention:
  • Currently pregnant or less than 3 months post-partum
  • CVD event within the past 3 months (STEMI or NSTEMI)
  • CVD manifesting any of the following criteria: Unstable angina pectoris or angina pectoris at rest, positive cardiac stress testing without completed work up or intervention, history of cardiac arrest, complex ventricular arrhythmia at rest or with exercise, uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more), New York Heart Association Class III or IV congestive heart failure, acute myocarditis, pericarditis, hypertrophic cardiomyopathy, clinically significant aortic stenosis, cardiac pacemaker - unless approved by a Cardiologist, implantable cardioverter defribrillator (ICD) device in situ, history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair, resting heart rate < 45 beats per minute or > 100 beats per minute, or heart transplantation.
  • Documented history of pulmonary embolus in past 6 months
  • Currently undergoing active cancer treatment
  • Renal disease manifesting any of the following criteria: Urine dipstick protein 4+, rerum creatinine > 124 µmol/L (female) or > 133 µmol/L (male), or currently receiving dialysis
  • Untreated proliferative neuropathy
  • Actively infected foot ulcer
  • Chronic obstructive pulmonary disease that would limit ability to participate in intervention
  • Chronic hepatitis B or C cirrhosis
  • Inflammatory bowel disease requiring corticosteroid treatment for acute flare within the past year
  • Endocrine disorder: Type 1 Diabetes, Cushing's syndrome or acromegaly
  • Any major organ transplant
  • HIV-positive
  • Active tuberculosis
  • Factors that may limit adherence to intervention: Inability to walk two blocks, lack of fluency in spoken English or French, hospitalization for depression in past 6 months, current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder, self-report of alcohol or substance use disorder within the past 12 months, or lack of support from Rosemount Clinic physician.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jennifer Crichton, MD 6132744851 jcrichton@qmed.ca

Sponsors and Collaborators
Ottawa Hospital Research Institute
Tracking Information
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
 (submitted: July 22, 2019)
  • Program adherence [ Time Frame: 3-months ]
    Percentage of participants who meet or exceed Canadian Diabetes Association guideline recommendations for exercise in type 2 diabetes
  • Program uptake [ Time Frame: 3-months ]
    Percentage of participants who attend the introductory session and at least one group class
  • Program retention [ Time Frame: 3-months ]
    Retention rate of participants
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
  • Health-related quality of life [ Time Frame: 0, 1, 2 and 3-months ]
    Change from baseline in 5-level EuroQol-5 Domain score (this is a quality of life scale where higher values indicate better quality of life) with Canadian index scores ranging from -0.148 (worst state) to 0.949 (best state).
  • Psychological experience with exercise [ Time Frame: 0, 1, 2 and 3-months ]
    Change from baseline in Basic Psychological Needs in Exercise Scale (measuring basic psychological needs in healthy physical exercise) score with scores ranging from 11 (worst) to 55 (best) (in other words higher scores indicate that needs are better met).
  • Willingness to recommend [ Time Frame: 3-months ]
    Participants will be asked to rate their "willingness to recommend" (Likert scale) the program to other individuals with type 2 diabetes (this is a 10-point scale where higher values indicate higher likelihood to recommend).
  • Blood pressure [ Time Frame: 0 and 3-months ]
    Baseline and post-intervention blood pressure measurements will be obtained from patient charts, as routinely collected during type 2 diabetes care every 3-months.
  • Hemoglobin A1c [ Time Frame: 0 and 3-months ]
    Baseline and post-intervention hemoglobin A1c measurements will be obtained from patient charts, as routinely collected during type 2 diabetes care every 3-months.
  • Hypothetical program cost per patient [ Time Frame: 3-months ]
    A hypothetical program cost per patient will be estimated to balance against the program benefits.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Health-related quality of life [ Time Frame: 0, 1, 2 and 3-months ]
    Change from baseline in 5-level EQ-5D score (EuroQol Group) with Canadian index scores ranging from -0.148 (worst state) to 0.949 (best state).
  • Psychological experience with exercise [ Time Frame: 0, 1, 2 and 3-months ]
    Change from baseline in Basic Physiologic Needs in Exercise Scale (BP-NES) score with scores ranging from 11 (worst) to 55 (best).
  • Willingness to recommend [ Time Frame: 3-months ]
    Participants will be asked to rate their "willingness to recommend" (Likert scale) the program to other individuals with type 2 diabetes.
  • Blood pressure [ Time Frame: 0 and 3-months ]
    Baseline and post-intervention blood pressure measurements will be obtained from patient charts, as routinely collected during type 2 diabetes care every 3-months.
  • Hemoglobin A1c [ Time Frame: 0 and 3-months ]
    Baseline and post-intervention hemoglobin A1c measurements will be obtained from patient charts, as routinely collected during type 2 diabetes care every 3-months.
  • Hypothetical program cost per patient [ Time Frame: 3-months ]
    A hypothetical program cost per patient will be estimated to balance against the program benefits.
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.

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
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Exercise
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.

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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2019)
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:

  • Adult (age >= 18 years) patients rostered with one of the Rosemount Clinic physicians with a clinical diagnosis of type 2 diabetes mellitus (fasting plasma glucose of >= 7.0 mmol/L, a 2-hour plasma glucose value in a 75 g oral glucose tolerance test of >= 11.1 mmol/L or a glycated hemoglobin (A1C) of >= 6.5%).

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.).

  • Pregnant
  • A1C > 11%
  • Blood pressure >= 160/100 mmHg
  • Fasting triglycerides >= 600 mg/dL
  • Underlying diseases that may limit life span and/or affect the safety of the intervention:
  • Currently pregnant or less than 3 months post-partum
  • CVD event within the past 3 months (STEMI or NSTEMI)
  • CVD manifesting any of the following criteria: Unstable angina pectoris or angina pectoris at rest, positive cardiac stress testing without completed work up or intervention, history of cardiac arrest, complex ventricular arrhythmia at rest or with exercise, uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more), New York Heart Association Class III or IV congestive heart failure, acute myocarditis, pericarditis, hypertrophic cardiomyopathy, clinically significant aortic stenosis, cardiac pacemaker - unless approved by a Cardiologist, implantable cardioverter defribrillator (ICD) device in situ, history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair, resting heart rate < 45 beats per minute or > 100 beats per minute, or heart transplantation.
  • Documented history of pulmonary embolus in past 6 months
  • Currently undergoing active cancer treatment
  • Renal disease manifesting any of the following criteria: Urine dipstick protein 4+, rerum creatinine > 124 µmol/L (female) or > 133 µmol/L (male), or currently receiving dialysis
  • Untreated proliferative neuropathy
  • Actively infected foot ulcer
  • Chronic obstructive pulmonary disease that would limit ability to participate in intervention
  • Chronic hepatitis B or C cirrhosis
  • Inflammatory bowel disease requiring corticosteroid treatment for acute flare within the past year
  • Endocrine disorder: Type 1 Diabetes, Cushing's syndrome or acromegaly
  • Any major organ transplant
  • HIV-positive
  • Active tuberculosis
  • Factors that may limit adherence to intervention: Inability to walk two blocks, lack of fluency in spoken English or French, hospitalization for depression in past 6 months, current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder, self-report of alcohol or substance use disorder within the past 12 months, or lack of support from Rosemount Clinic physician.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jennifer Crichton, MD 6132744851 jcrichton@qmed.ca
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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