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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Canadian Diabetes Association
Information provided by (Responsible Party):
Rob Petrella, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01944124
First received: September 12, 2013
Last updated: October 21, 2013
Last verified: October 2013

September 12, 2013
October 21, 2013
November 2009
March 2011   (final data collection date for primary outcome measure)
Systolic Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01944124 on ClinicalTrials.gov Archive Site
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Exercise and Technology to Reduce Risk in a Rural Population With Metabolic Syndrome
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.

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.

Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Metabolic Syndrome X
  • 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.
  • Behavioral: 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.
  • Experimental: Exercise Prescription + Mobile Health
    Received a tailored exercise prescription and mobile health technology kit to track blood pressure, blood glucose, physical activity and body weight.
    Interventions:
    • Behavioral: Mobile Health
    • Behavioral: Exercise Prescription
  • Active Comparator: Exercise Prescription
    Received a tailored exercise prescription only.
    Intervention: Behavioral: Exercise Prescription

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
December 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01944124
15828
No
Rob Petrella, Lawson Health Research Institute
Lawson Health Research Institute
  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Canada
  • Canadian Diabetes Association
Principal Investigator: Robert J Petrella, MD, PhD Lawson Health Research Institute
Lawson Health Research Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP