Adverse events among high-risk participants in a home-based walking study: a descriptive study
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BioMed Central
Open Access
Research
Adverse events among high-risk participants in a home-based walking study: a descriptive study David E Goodrich1,2, Angela R Larkin1, Julie C Lowery1, Robert G Holleman1,2 and Caroline R Richardson*1,2 Address: 1HSR&D Center for Excellence, VA Health Care Medical Center, P.O. Box 130170, Ann Arbor, MI 48113-0170, USA and 2Department of Family Medicine, University of Michigan, 1018 Fuller St. SPC: 5708, Ann Arbor, MI 48109-5708, USA Email: David E Goodrich - [email protected]; Angela R Larkin - [email protected]; Julie C Lowery - [email protected]; Robert G Holleman - [email protected]; Caroline R Richardson* - [email protected] * Corresponding author
Published: 23 May 2007 International Journal of Behavioral Nutrition and Physical Activity 2007, 4:20 5868-4-20
doi:10.1186/1479-
Received: 25 January 2007 Accepted: 23 May 2007
This article is available from: http://www.ijbnpa.org/content/4/1/20 © 2007 Goodrich et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract Background: For high-risk individuals and their healthcare providers, finding the right balance between promoting physical activity and minimizing the risk of adverse events can be difficult. More information on the prevalence and influence of adverse events is needed to improve providers' ability to prescribe effective and safe exercise programs for their patients. Methods: This study describes the type and severity of adverse events reported by participants with cardiovascular disease or at-risk for cardiovascular disease that occurred during an unsupervised, home-based walking study. This multi-site, randomized controlled trial tested the feasibility of a diet and lifestyle activity intervention over 1.5 years. At month 13, 274 eligible participants (male veterans) were recruited who were ambulatory, BMI > 28, and reporting one or more cardiovascular disease risk factors. All participants attended five, face-to-face dietitian-delivered counseling sessions during the six-month intervention. Participants were randomized to three study arms: 1) time-based walking goals, 2) simple pedometer-based walking goals, and 3) enhanced pedometer-based walking goals with Internet-mediated feedback. Two physicians verified adverse event symptom coding. Results: Enrolled participants had an average of five medical comorbidities. During 1110 person months of observation, 87 of 274 participants reported 121 adverse events. One serious study-related adverse event (atrial fibrillation) was reported; the individual resumed study participation within three days. Non-serious, study related adverse events made up 12% of all symptoms – predominantly minor musculoskeletal events. Serious, non-study related adverse events represented 32% of all symptoms while non-serious,
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