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

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mobile Health
Exercise Prescription
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome X focused on measuring Mobile health, Metabolic syndrome, Exercise prescription, Exercise intervention, Disease prevention, Rural health

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gateway Rural Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Prescription + Mobile Health

Exercise Prescription

Arm Description

Received a tailored exercise prescription and mobile health technology kit to track blood pressure, blood glucose, physical activity and body weight.

Received a tailored exercise prescription only.

Outcomes

Primary Outcome Measures

Systolic Blood Pressure

Secondary Outcome Measures

Full Information

First Posted
September 12, 2013
Last Updated
October 21, 2013
Sponsor
Lawson Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Canadian Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT01944124
Brief Title
Exercise and Technology to Reduce Risk in a Rural Population With Metabolic Syndrome
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Canadian Diabetes Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
Mobile health, Metabolic syndrome, Exercise prescription, Exercise intervention, Disease prevention, Rural health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Prescription + Mobile Health
Arm Type
Experimental
Arm Description
Received a tailored exercise prescription and mobile health technology kit to track blood pressure, blood glucose, physical activity and body weight.
Arm Title
Exercise Prescription
Arm Type
Active Comparator
Arm Description
Received a tailored exercise prescription only.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Health
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Prescription
Intervention Description
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.
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Petrella, MD, PhD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gateway Rural Health Research Institute
City
Seaforth
State/Province
Ontario
ZIP/Postal Code
N0K 1W0
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25757039
Citation
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.
Results Reference
derived
PubMed Identifier
25326074
Citation
Petrella 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.
Results Reference
derived
PubMed Identifier
24199747
Citation
Stuckey 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.
Results Reference
derived

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

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