Dataset Information

A randomised controlled trial of three pragmatic approaches to initiate increased physical activity in sedentary patients with risk factors for cardiovascular disease.

ABSTRACT:

Background

Physical activity is a major modifiable risk factor for cardiovascular disease, but it is unclear what combination of feasible approaches, using existing resources in primary care, work best to initiate increased physical activity.

Aim

To assess three approaches to initiate increased physical activity.

Design of study

Randomised controlled (2 X 2 X 2) factorial trial.

Setting

Four general practices.

Method

One hundred and fifty-one sedentary patients with computer documented risk factors for cardiovascular disease were randomised to eight groups defined by three factors: prescription by general practitioners (GPs) for brisk exercise not requiring a leisure facility (for example, walking) 30 minutes per day, 5 days per week; counselling by practice nurses, based on psychological theory to modify intentions and perceived control of behaviour, and using behavioural implementation techniques (for example, contracting, 'rehearsal'); use of the Health Education Authority booklet 'Getting active, feeling fit'.

Results

Single interventions had modest effects. There was a trend from the least intensive interventions (control +/- booklet) to the more intensive interventions (prescription and counselling combined +/- booklet) for both increased physical activity and fitness (test for trend, P = 0.02 and P = 0.05, respectively). Only with the most intense intervention (prescription and counselling combined) were there significant increases in both physical activity and fitness from baseline (Godin score = 14.4, 95% confidence interval [CI] = 7.8 to 21, which was equivalent to three 15-minute sessions of brisk exercise and a 6-minute walking distance = 28.5 m, respectively, 95% CI = 11.1 to 45.8). Counselling only made a difference among those individuals with lower intention at baseline.

Conclusion

Feasible interventions using available staff, which combine exercise prescription and counselling explicitly based on psychological theory, can probably initiate important increases in physical activity.

SUBMITTER: Little P

PROVIDER: S-EPMC1314829 | biostudies-literature | 2004 Mar

REPOSITORIES: biostudies-literature

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Publications

A randomised controlled trial of three pragmatic approaches to initiate increased physical activity in sedentary patients with risk factors for cardiovascular disease.

Little Paul P Dorward Martina M Gralton Sarah S Hammerton Louise L Pillinger John J White Peter P Moore Michael M McKenna Jim J Payne Sheila S

The British journal of general practice : the journal of the Royal College of General Practitioners 20040301 500

<h4>Background</h4>Physical activity is a major modifiable risk factor for cardiovascular disease, but it is unclear what combination of feasible approaches, using existing resources in primary care, work best to initiate increased physical activity.<h4>Aim</h4>To assess three approaches to initiate increased physical activity.<h4>Design of study</h4>Randomised controlled (2 X 2 X 2) factorial trial.<h4>Setting</h4>Four general practices.<h4>Method</h4>One hundred and fifty-one sedentary patient ...[more]

PMID: 15006124

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Project description:BackgroundPhysical activity (PA) improves many facets of health. Despite this, the majority of American adults are insufficiently active. Adults who visit a physician complaining of chest pain and related cardiovascular symptoms are often referred for further testing. However, when this testing does not reveal an underlying disease or pathology, patients typically receive no additional standard care services. A PA intervention delivered within the clinic setting may be an effective strategy for improving the health of this population at a time when they may be motivated to take preventive action.ObjectiveOur aim was to determine the effectiveness of a tailored, computer-based, interactive personal action planning session to initiate PA among a group of sedentary cardiac patients following exercise treadmill testing (ETT).MethodsThis study was part of a larger 2x2 randomized controlled trial to determine the impact of environmental and social-cognitive intervention approaches on the initiation and maintenance of weekly PA for patients post ETT. Participants who were referred to an ETT center but had a negative-test (ie, stress tests results indicated no apparent cardiac issues) were randomized to one of four treatment arms: (1) increased environmental accessibility to PA resources via the provision of a free voucher to a fitness facility in close proximity to their home or workplace (ENV), (2) a tailored social cognitive intervention (SC) using a "5 As"-based (ask, advise, assess, assist, and arrange) personal action planning tool, (3) combined intervention of both ENV and SC approaches (COMBO), or (4) a matched contact nutrition control (CON). Each intervention was delivered using a computer-based interactive session. A general linear model for repeated measures was conducted with change in PA behavior from baseline to 1-month post interactive computer session as the primary outcome.ResultsSedentary participants (n=452; 34.7% participation rate) without a gym membership (mean age 58.57 years; 59% female, 78% white, 12% black, 11% Hispanic) completed a baseline assessment and an interactive computer session. PA increased across the study sample (F1,441=30.03, P<.001). However, a time by condition interaction (F3,441=8.33, P<.001) followed by post hoc analyses indicated that SC participants exhibited a significant increase in weekly PA participation (mean 45.1, SD 10.2) compared to CON (mean -2.5, SD 10.8, P=.004) and ENV (mean 8.3, SD 8.1, P<.05). Additionally, COMBO participants exhibited a significant increase in weekly PA participation (mean 53.4, SD 8.9) compared to CON (P<.001) and ENV (P=.003) participants. There were no significant differences between ENV and CON or between SC and COMBO.ConclusionsA brief, computer-based, interactive personal action planning session may be an effective tool to initiate PA within a health care setting, in particular as part of the ETT system.Trial registrationClinicaltrials.gov NCT00432133, http://clinicaltrials.gov/ct2/show/NCT00432133 (Archived by WebCite at http://www.webcitation.org/6aa8X3mw1).

Project description:BackgroundImplementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.MethodsA pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.ResultsNineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.ConclusionsThis was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.Trial registrationISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

Project description:BackgroundInterventions to increase physical activity or reduce sedentary behaviour within the workplace setting have shown mixed effects. This cluster randomised controlled trial assessed whether multi-component interventions, focusing on changes at the individual, environmental, and organisational levels, either increased physical activity or reduced sedentary behaviour, compared to a passive control group.MethodsTeams of office-workers from two companies participated in one of two interventions (iPA: targeting physical activity; or iSED: targeting sedentary behaviour), or wait-list control group (C). Exclusion criterion was very high physical activity level (MVPA ≥30 min/day in ≥10 min bouts every day). Randomisation occurred at the level of workplace cluster, and groups were randomly allocated (1:1) with stratification for company and cluster size. Personnel involved in data collection and processing were blinded to group allocation. Both interventions included five sessions of cognitive behavioural therapy counselling for 6 months. iPA included counselling focused on physical activity, access to a gym, and encouragement to exercise, and go for lunch walks. iSED included counselling on sedentary behaviour and encouragement to reduce sitting and increase engagement in standing- and walking-meetings. At baseline and the 6-month mark accelerometers were worn on the hip and thigh for 7 days. The primary outcomes were group differences in time spent in moderate-to-vigorous intensity physical activity (%MVPA) and in sedentary behaviour (%), analysed using Bayesian multilevel modelling for those with complete data.ResultsTwo-hundred and sixty three office workers (73% women, mean age 42 ± 9 years, education 15 ± 2 years) were randomised into 23 cluster teams (iPA n = 84, 8 clusters; iSED n = 87, 7 clusters; C n = 92, 7 clusters). No significant group differences (posterior mean ratios: 95% credible interval) were found after the intervention for %MVPA or for %Sedentary. %MVPA: iPA vs C (0·04: - 0·80-0·82); iSED vs C (0·47: - 0·41-1·32); iPA vs iSED (0·43: - 0·42-1·27). %Sedentary: iPA vs C (1·16: - 1·66-4·02); iSED vs C (- 0·44: - 3·50-2·64); iPA vs iSED (- 1·60: - 4·72-1·47).ConclusionsThe multi-component interventions focusing on either physical activity or sedentary behaviour were unsuccessful at increasing device-measured physical activity or reducing sedentary behaviour compared to a control group.Trial registrationISRCTN, ISRCTN92968402 . Registered 27/2/2018, recruitment started 15/03/2018.

Project description:Objective To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies.Design Pragmatic, multicentre, randomised controlled trial.Setting 42 general practices in three areas of England.Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score.Interventions Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone.Main outcome measures The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked.Results 50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic -2.7 mm Hg (95% confidence interval -4.7 to -0.6 mm Hg), mean diastolic -2.8 (-4.0 to -1.6 mm Hg); weight -1.0 kg (-1.8 to -0.3 kg), and body mass index -0.4 ( -0.6 to -0.1) but not cholesterol -0.1 (-0.2 to 0.0), smoking status (adjusted odds ratio 0.4, 0.2 to 1.0), or overall cardiovascular risk as a continuous measure (-0.4, -1.2 to 0.3)). The intervention was associated with improvements in diet, physical activity, drug adherence, and satisfaction with access to care, treatment received, and care coordination. One serious related adverse event occurred, when a participant was admitted to hospital with low blood pressure.Conclusions This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk, and there was no overall improvement in average risk. The Healthlines service was, however, associated with improvements in some risk behaviours, and in perceptions of support and access to care.Trial registration Current Controlled Trials ISRCTN 27508731.

Project description:BackgroundEvidence that higher sedentary time is associated with higher risk for cardiovascular disease (CVD) is based mainly on self-reported measures. Few studies have examined whether patterns of sedentary time are associated with higher risk for CVD.MethodsWomen from the Objective Physical Activity and Cardiovascular Health (OPACH) Study (n=5638, aged 63-97, mean age=79±7) with no history of myocardial infarction (MI) or stroke wore accelerometers for 4-to-7 days and were followed for up to 4.9 years for CVD events. Average daily sedentary time and mean sedentary bout duration were the exposures of interest. Cox regression models estimated hazard ratios (HR) and 95% confidence intervals (CI) for CVD using models adjusted for covariates and subsequently adjusted for potential mediators (body mass index (BMI), diabetes, hypertension, and CVD-risk biomarkers [fasting glucose, high-density lipoprotein, triglycerides, and systolic blood pressure]). Restricted cubic spline regression characterized dose-response relationships.ResultsThere were 545 CVD events during 19,350 person-years. Adjusting for covariates, women in the highest (≥ ~11 hr/day) vs. the lowest (≤ ~9 hr/day) quartile of sedentary time had higher risk for CVD (HR=1.62; CI=1.21-2.17; p-trend <0.001). Further adjustment for potential mediators attenuated but did not eliminate significance of these associations (p-trend<.05, each). Longer vs. shorter mean bout duration was associated with higher risks for CVD (HR=1.54; CI=1.27-2.02; p-trend=0.003) after adjustment for covariates. Additional adjustment for CVD-risk biomarkers attenuated associations resulting in a quartile 4 vs. quartile 1 HR=1.36; CI=1.01-1.83; p-trend=0.10). Dose-response associations of sedentary time and bout duration with CVD were linear (P-nonlinear >0.05, each). Women jointly classified as having high sedentary time and long bout durations had significantly higher risk for CVD (HR=1.34; CI=1.08-1.65) than women with both low sedentary time and short bout duration. All analyses were repeated for incident coronary heart disease (MI or CVD death) and associations were similar with notably stronger hazard ratios.ConclusionsBoth high sedentary time and long mean bout durations were associated in a dose-response manner with increased CVD risk in older women, suggesting that efforts to reduce CVD burden may benefit from addressing either or both component(s) of sedentary behavior.

Dataset Information

A randomised controlled trial of three pragmatic approaches to initiate increased physical activity in sedentary patients with risk factors for cardiovascular disease.

Background

Aim

Design of study

Setting

Method

Results

Conclusion

Publications

A randomised controlled trial of three pragmatic approaches to initiate increased physical activity in sedentary patients with risk factors for cardiovascular disease.

Similar Datasets

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