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

NCT04030364 | Unknown

• 1 other identifier: 20190116-01H
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2; Exercise

Outcome Measures

Primary Outcomes (3)

• Program adherence

  Percentage of participants who meet or exceed Canadian Diabetes Association guideline recommendations for exercise in type 2 diabetes

  3-months

• Program uptake

  Percentage of participants who attend the introductory session and at least one group class

  3-months

• Program retention

  Retention rate of participants

  3-months

Secondary Outcomes (6)

• Health-related quality of life

  0, 1, 2 and 3-months

• Psychological experience with exercise

  0, 1, 2 and 3-months

• Willingness to recommend

  3-months

• Blood pressure

  0 and 3-months

• Hemoglobin A1c

  0 and 3-months

Study Arms (1)

Self-referral to group exercise classes

OTHER

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

Interventions

CrossFit group exercise classes BEHAVIORAL

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.

Self-referral to group exercise classes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Central Study Contacts

Jennifer Crichton, MD

CONTACT

6132744851; jcrichton@qmed.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 24, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share