Dataset Information

Adverse events among high-risk participants in a home-based walking study: a descriptive study.

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, non-study related adverse events made up 56% of symptoms. Cardiovascular disease events represented over half of the non-study related adverse event symptoms followed by musculoskeletal complaints. Adverse events caused 50 temporary suspensions averaging 26 days in duration before physician medical clearance was obtained to resume walking.

Conclusion

Men at high risk for adverse cardiovascular events can safely be advised to start a progressive walking program. Results suggest that minor to serious medical problems unrelated to exercise are a major barrier to walking adherence. Helping individuals with chronic illness return to physical activity quickly but safely after an adverse event is an important component of any physical activity intervention targeting this population.

SUBMITTER: Goodrich DE

PROVIDER: S-EPMC1891313 | biostudies-literature | 2007 May

REPOSITORIES: biostudies-literature

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Publications

Adverse events among high-risk participants in a home-based walking study: a descriptive study.

Goodrich David E DE Larkin Angela R AR Lowery Julie C JC Holleman Robert G RG Richardson Caroline R CR

The international journal of behavioral nutrition and physical activity 20070523

<h4>Background</h4>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.<h4>Methods</h4>This study describes the type and severity of adverse events reported by participants with cardiovascular dis ...[more]

PMID: 17521443

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Project description:BackgroundWhilst the benefits of physical activity for health and wellbeing are recognised, population levels of activity remain low. Significant inequalities exist, with socioeconomically disadvantaged populations being less physically active and less likely to participate in community events. We investigated the perceived benefits from participation in a weekly running/walking event called parkrun by those living in the most socioeconomically deprived areas and doing the least physical activity.MethodsA cross-sectional online survey was emailed to 2,318,135 parkrun participants in the UK. Demographic and self-reported data was collected on life satisfaction, happiness, health status, physical activity, motives, and the perceived benefits of parkrun. Motivation, health status and benefits were compared for sub-groups defined by physical activity level at parkrun registration and residential Index of Multiple Deprivation.Results60,000 completed surveys were received (2.7% of those contacted). Respondents were more recently registered with parkrun (3.1 v. 3.5 years) than the parkrun population and had a higher frequency of parkrun participation (14.5 v. 3.7 parkruns per year). Those inactive at registration and from deprived areas reported lower happiness, lower life satisfaction and poorer health compared to the full sample. They were more likely to want to improve their physical health, rather than get fit or for competition. Of those reporting less than one bout of activity per week at registration, 88% (87% in the most deprived areas) increased their physical activity level and 52% (65% in the most deprived areas) reported improvements to overall health behaviours. When compared to the full sample, a greater proportion of previously inactive respondents from the most deprived areas reported improvements to fitness (92% v. 89%), physical health (90% v. 85%), happiness (84% v. 79%) and mental health (76% v. 69%).ConclusionThe least active respondents from the most socioeconomically deprived areas reported increases to their activity levels and benefits to health and wellbeing since participating in parkrun. Whilst the challenge of identifying how community initiatives like parkrun can better engage with underrepresented populations remains, if this can be achieved they could have a critical public health role in addressing inequalities in benefits associated with recreational physical activity.

Project description:Background:Poor oral hygiene is strongly associated with oral and systemic diseases. Alongside mechanical tooth cleaning, the adjunctive use of mouthrinses has been widely advocated. Although research on the efficacy of various mouthrinse formulations is very active, there are a lack of conclusive data regarding their adverse effects. Methods:We undertook a systematic review in accordance wih PRISMA guidelines of electronic databases of clinical trials of any duration with daily home use of mouthwashes, presenting clinical and subjective side effects (PROSPERO registration: CRD42016054037). Results:After evaluating 614 titles and abstracts, 154 studies were selected for full-text analysis; 85 final papers were included. Based on the active ingredient in the test product, nine categories were created: cetyl pyridinium chloride, essential oils, chlorhexidine, triclosan, natural products, diclofenac, fluorides, delmopinol, and miscellaneous active substances. Most of the studies were of short duration (less than 6 months) with a defective 'methods' description; the reporting of adverse events often being overlooked. Both local morphological (oral mucosa and dental-crown staining, mucosal lesions) and functional (taste modifications, abnormal oral sensation) alterations were reported. Tooth staining was the most commonly listed adverse event, but it was quantitatively assessed only in a very small number of papers; most studies relied on patient reports. Staining was time associated; the longer the study, the higher its reported incidence and severity. Conclusions:The reduced report of side effects may partly be due to a lack of an objective measure and lack of general guidelines that demand studies report their adverse events. The most frequently reported adverse effect was teeth staining. As in most studies, the effect was associated with trial duration; clinical trials should be of sufficient duration. New investigations meeting the suggested criteria of a minimal duration of 6 months should be planned.

Project description:ObjectiveTo assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports.DesignSystematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report.Setting9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval.Data sourcesClinical study reports obtained from the EMA in 2011.ResultsSix trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used.ConclusionData on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives of adverse events can provide additional information, including original investigator reported adverse event terms, which can enable a more accurate estimate of harms.

Dataset Information

Adverse events among high-risk participants in a home-based walking study: a descriptive study.

Background

Methods

Results

Conclusion

Publications

Adverse events among high-risk participants in a home-based walking study: a descriptive study.

Similar Datasets

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