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

Metabolic Syndrome X Clinical Trial

Official title:

A Lifestyle Intervention Supported by Mobile Health Technologies to Improve the Cardiometabolic Risk Profile of Individuals at Risk for Cardiovascular Disease and Type 2 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944124
• Other study ID #: 15828
• Status: Completed
• Phase: N/A
• First received: September 12, 2013
• Last updated: October 21, 2013
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2013
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome X

Intervention

Behavioral:
• Mobile Health
Participants monitored their blood pressure 3x per week, blood glucose 1x per week, pedometer steps daily and body weight monthly. Measures from devices were transferred or inputted to a smartphone data portal. Planned exercise was logged electronically on the smartphone.
• Exercise Prescription
An exercise program was prescribed tailored to participant fitness level (using the Step Test Exercise Prescription (STEP-TM) protocol). Briefly, STEP-TM required participants to step up and down a set of 2 steps 20 times at a comfortable pace. A predictive equation including post-test heart rate, time to complete test, age, body weight and sex was used to calculate fitness. An exercise program was prescribed including aerobic exercise most days of the week for 30-60 minutes in duration at a target heart rate tailored to fitness level. Light resistance training was also prescribed 2-4 times per week.

Locations

Country	Name	City	State
Canada	Gateway Rural Health Research Institute	Seaforth	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Diabetes Association, Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure		12 weeks	No