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
  Purpose

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.


Condition Intervention
Metabolic Syndrome X
Behavioral: Mobile Health
Behavioral: Exercise Prescription

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Active Comparator: Exercise Prescription
Received a tailored exercise prescription only.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944124

Locations
Canada, Ontario
Gateway Rural Health Research Institute
Seaforth, Ontario, Canada, N0K 1W0
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Canadian Diabetes Association
Investigators
Principal Investigator: Robert J Petrella, MD, PhD Lawson Health Research Institute
  More Information

No publications provided by Lawson Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rob Petrella, Beryl and Ivey Research Chair, Aging, Rehabilitation and Geriatric Care Research Centre, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01944124     History of Changes
Other Study ID Numbers: 15828
Study First Received: September 12, 2013
Last Updated: October 21, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Lawson Health Research Institute:
Mobile health
Metabolic syndrome
Exercise prescription
Exercise intervention
Disease prevention
Rural health

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014