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.
1 other identifier
interventional
149
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 12, 2013
CompletedFirst Posted
Study publicly available on registry
September 17, 2013
CompletedOctober 22, 2013
October 1, 2013
1.3 years
September 12, 2013
October 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systolic Blood Pressure
12 weeks
Study Arms (2)
Exercise Prescription + Mobile Health
EXPERIMENTALReceived a tailored exercise prescription and mobile health technology kit to track blood pressure, blood glucose, physical activity and body weight.
Exercise Prescription
ACTIVE COMPARATORReceived a tailored exercise prescription only.
Interventions
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.
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 Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gateway Rural Health Research Institute
Seaforth, Ontario, N0K 1W0, Canada
Related Publications (3)
Stuckey MI, Gill DP, Petrella RJ. Does Systolic Blood Pressure Response to Lifestyle Intervention Indicate Metabolic Risk and Health-Related Quality-of-Life Improvement Over 1 Year? J Clin Hypertens (Greenwich). 2015 May;17(5):375-80. doi: 10.1111/jch.12531. Epub 2015 Mar 10.
PMID: 25757039DERIVEDPetrella RJ, Stuckey MI, Shapiro S, Gill DP. Mobile health, exercise and metabolic risk: a randomized controlled trial. BMC Public Health. 2014 Oct 18;14:1082. doi: 10.1186/1471-2458-14-1082.
PMID: 25326074DERIVEDStuckey MI, Shapiro S, Gill DP, Petrella RJ. 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: study rationale and protocol. BMC Public Health. 2013 Nov 7;13:1051. doi: 10.1186/1471-2458-13-1051.
PMID: 24199747DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Petrella, MD, PhD
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Beryl and Ivey Research Chair, Aging, Rehabilitation and Geriatric Care Research Centre
Study Record Dates
First Submitted
September 12, 2013
First Posted
September 17, 2013
Study Start
November 1, 2009
Primary Completion
March 1, 2011
Study Completion
December 1, 2011
Last Updated
October 22, 2013
Record last verified: 2013-10