Exercise and Technology to Reduce Risk in a Rural Population With Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome X
• Interventions: Behavioral: Exercise Prescription; Behavioral: Mobile Health

• Registration Number: NCT01944124
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

Cardiovascular diseases are the leading cause of death among Canadians. In those with diabetes, cardiovascular complications are responsible for more than 70% of deaths. While there is much interest in identifying and treating risk factors, the exact biological mechanisms, their measurement and optimal ways to prevent and manage them are poorly understood.

Physical activity and regular exercise can prevent diabetes and effectively manage risk factors, but most Canadians do not exercise enough to beneficially manage risk. Tailored exercise prescribed by a family physician has shown promise as a means to increase fitness and reduce risk, but optimal implementation practices remain unknown - especially in rural and remote communities with reduced access to healthcare. Mobile health technologies have proved to be a beneficial tool to achieve blood pressure and blood glucose control in patients with diabetes. These technologies may address the limited access to health interventions in rural and remote regions. However, the potential as a tool to support exercise-based prevention activities unknown.

Therefore, this study was undertaken to investigate the effects of a tailored exercise prescription alone or supported by mobile health technologies to improve cardiovascular risk factors in rural community-dwelling adults at risk for cardiovascular disease and type 2 diabetes.

Adults with cardiovascular risk factors were recruited from rural communities and randomized to either: 1) an intervention group receiving an exercise prescription and devices for monitoring of risk factors with a smartphone data portal equipped with a mobile health application; or 2) an active control group receiving only an exercise prescription.

It was hypothesized that the intervention group would reduce their risk to a greater extent than the active control group following 12 weeks, and that these improvements would be better maintained in the intervention group at 24 and 52 weeks compared to the active control group.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2011-03
• Study Completion: 2011-12
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-17
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-21
• Last Update Posted: 2013-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• aged 18-70 years
• two or more metabolic syndrome risk factors according to National Cholesterol Education Program Adult Treatment Panel III criteria: waist circumference ≥ 88 cm (women) or ≥ 102 cm (men); systolic blood pressure ≥ 135 mmHg and/or diastolic blood pressure ≥ 85 mmHg; fasting plasma glucose ≥ 6.1 mmol/L; triglycerides ≥ 1.7 mmol/L; and high density lipoprotein cholesterol ≤ 1.29 mmol/L (women) or ≤ 1.02 mmol/L (men)

Exclusion Criteria

• systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110mmHg
• type 1 diabetes
• history of myocardial infarction, angioplasty, coronary artery bypass or cerebrovascular ischemia/stroke
• symptomatic congestive heart failure
• atrial flutter
• unstable angina
• unstable pulmonary disease
• use of medications known to affect heart rate
• second or third degree heart block
• history of alcoholism, drug abuse or other emotional cognitive or psychiatric problems
• pacemaker
• unstable metabolic disease and orthopedic or rheumatologic problems that could impair the ability to exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Prescription	Exercise Prescription	Received a tailored exercise prescription only.
Exercise Prescription + Mobile Health	Exercise Prescription	Received a tailored exercise prescription and mobile health technology kit to track blood pressure, blood glucose, physical activity and body weight.
Exercise Prescription + Mobile Health	Mobile Health	Received a tailored exercise prescription and mobile health technology kit to track blood pressure, blood glucose, physical activity and body weight.

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	12 weeks

Trial Locations

Locations (1)

Gateway Rural Health Research Institute; 🇨🇦 Seaforth, Ontario, Canada