Reducing sedentary time using an innovative mHealth intervention among patients with total knee replacement: Rationale and study protocol.
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ABSTRACT: Introduction
Although knee replacement is effective for improving pain and physical function, subsequent improvements in physical activity typically do not follow. As a result, many patients spend most of their day engaged in sedentary behavior, which may put them at higher risk of experiencing poor function and disability. Intervening on sedentary time, rather than physical activity, may be a more feasible first-step approach for modifying activity-related behaviors in adults who received knee replacement.Objective
The purpose of this study is to examine the use of a mobile health (mHealth) intervention to reduce sedentary time among adults who received a knee replacement at 3 and 6 months after surgery.Methods
Patients (n = 92) scheduled for knee replacement will be recruited and at 4 weeks after surgery, they will be randomized to either NEAT!2 or Control. NEAT!2 participants will use the NEAT!2 smartphone app, which provides a vibration and/or audible tone to interrupt prolonged bouts of sitting detected from the smartphone's internal accelerometer, until 3 months after surgery. NEAT!2 participants will receive biweekly coaching calls between 4 and 12 weeks after surgery. Control participants will receive an education control app and receive non-intervention calls to assess general surgery recovery. Both groups will receive 3 retention calls between 3 and 6 months. Data collection will occur pre-operatively and at 3 and 6 months after surgery.Discussion
The results of this study will help to determine whether an innovative remotely-delivered, mHealth sedentary reduction intervention can decrease sedentary time in adults after knee replacement.
SUBMITTER: Pellegrini CA
PROVIDER: S-EPMC8239442 | biostudies-literature |
REPOSITORIES: biostudies-literature
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2017-12-13 | E-MTAB-6266 | biostudies-arrayexpress
Project description:BackgroundThe definitive treatment for knee osteoarthritis is a total knee replacement, which results in a clinically meaningful improvement in pain and physical function. However, evidence suggests that physical activity (PA) remains unchanged after total knee replacement (TKR).ObjectiveThe objective of this study is to investigate the efficacy, fidelity, and safety of a physical therapist-administered PA intervention for people after TKR.DesignThis study will be a randomized controlled trial.SettingThe setting is an outpatient physical therapy clinic.ParticipantsThe participants are 125 individuals who are over the age of 45 and are seeking outpatient physical therapy following a unilateral TKR.InterventionIn addition to standardized physical therapy after TKR, the intervention group will receive, during physical therapy, a weekly PA intervention that includes a wearable activity tracking device, individualized step goals, and face-to-face feedback provided by a physical therapist.ControlThe control group will receive standardized physical therapy alone after TKR.MeasurementsThe efficacy of the intervention will be measured as minutes per week spent in moderate to vigorous PA at enrollment, at discharge, and at 6 months and 12 months after discharge from physical therapy. The fidelity and safety of the intervention will be assessed throughout the study.LimitationsParticipants will not be masked, PA data will be collected after randomization, and the trial will be conducted at a single site.ConclusionsThe goal of this randomized controlled trial is to increase PA after TKR. A protocol for investigating the efficacy, fidelity, and safety of a physical therapist-administered PA intervention for people after TKR is presented. The findings will be used to support a large multisite clinical trial to test the effectiveness, implementation, and cost of this intervention.
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Project description:BackgroundImproving physical activity and reducing sedentary behavior represent important areas for intervention in childhood in order to reduce the burden of chronic disease related to obesity and physical inactivity in later life. This paper aims to determine the cost-effectiveness of a multi-arm primary school-based intervention to increase physical activity and/or reduce sedentary time in 8-9 year old children (Transform-Us!).MethodsModelled cost-utility analysis, using costs and effects from a cluster randomized controlled trial of a 30-month intervention that used pedagogical and environmental strategies to reduce and break up sedentary behaviour (SB-I), promote physical activity (PA-I), or a combined approach (PA + SB-I), compared to current practice. A validated multiple-cohort lifetable model (ACE-Obesity Policy model) estimated the obesity and physical activity-related health outcomes (measured as change in body mass index and change in metabolic equivalent task minutes respectively) and healthcare cost-savings over the cohort's lifetime from the public-payer perspective, assuming the intervention was delivered to all 8-9 year old children attending Australian Government primary schools. Sensitivity analyses tested the impact on cost-effectiveness of varying key input parameters, including maintenance of intervention effect assumptions.ResultsCost-effectiveness results demonstrated that, when compared to control schools, the PA-I and SB-I intervention arms were "dominant", meaning that they resulted in net health benefits and healthcare cost-savings if the intervention effects were maintained. When the costs and effects of these intervention arms were extrapolated to the Australian population, results suggested significant potential as obesity prevention measures (PA-I: 60,780 HALYs saved (95% UI 15,007-109,413), healthcare cost-savings AUD641M (95% UI AUD165M-$1.1B); SB-I: 61,126 HALYs saved (95% UI 11,770 - 111,249), healthcare cost-savings AUD654M (95% UI AUD126M-1.2B)). The PA-I and SB-I interventions remained cost-effective in sensitivity analysis, assuming the full decay of intervention effect after 10 years.ConclusionsThe PA-I and SB-I Transform-Us! intervention arms represent good value for money and could lead to health benefits and healthcare cost-savings arising from the prevention of chronic disease in later life if intervention effects are sustained.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN83725066). Australia and New Zealand Clinical Trials Registry Number (ACTRN12609000715279).
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Project description:BackgroundThere is little scientific evidence to support the usual practice of providing outpatient rehabilitation to patients undergoing total knee replacement surgery (TKR) immediately after discharge from the orthopaedic ward. It is hypothesised that the lack of clinical benefit is due to the low exercise intensity tolerated at this time, with patients still recovering from the effects of major orthopaedic surgery. The aim of the proposed clinical trial is to investigate the clinical and cost effectiveness of a novel rehabilitation strategy, consisting of an initial home exercise programme followed, approximately six weeks later, by higher intensity outpatient exercise classes.Methods/designIn this multicentre randomised controlled trial, 600 patients undergoing primary TKR will be recruited at the orthopaedic pre-admission clinic of 10 large public and private hospitals in Australia. There will be no change to the medical or rehabilitative care usually provided while the participant is admitted to the orthopaedic ward. After TKR, but prior to discharge from the orthopaedic ward, participants will be randomised to either the novel rehabilitation strategy or usual rehabilitative care as provided by the hospital or recommended by the orthopaedic surgeon. Outcomes assessments will be conducted at baseline (pre-admission clinic) and at 6 weeks, 6 months and 12 months following randomisation. The primary outcomes will be self-reported knee pain and physical function. Secondary outcomes include quality of life and objective measures of physical performance. Health economic data (health sector and community service utilisation, loss of productivity) will be recorded prospectively by participants in a patient diary. This patient cohort will also be followed-up annually for five years for knee pain, physical function and the need or actual incidence of further joint replacement surgery.DiscussionThe results of this pragmatic clinical trial can be directly implemented into clinical practice. If beneficial, the novel rehabilitation strategy of utilising outpatient exercise classes during a later rehabilitation phase would provide a feasible and potentially cost-effective intervention to optimise the physical well-being of the large number of people undergoing TKR.Trial registrationACTRN12609000054213.
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