Dataset Information

Efficacy of a Community-Based Technology-Enabled Physical Activity Counseling Program for People With Knee Osteoarthritis: Proof-of-Concept Study.

ABSTRACT: BACKGROUND:Current practice guidelines emphasize the use of physical activity as the first-line treatment of knee osteoarthritis; however, up to 90% of people with osteoarthritis are inactive. OBJECTIVE:We aimed to assess the efficacy of a technology-enabled counseling intervention for improving physical activity in people with either a physician-confirmed diagnosis of knee osteoarthritis or having passed two validated criteria for early osteoarthritis. METHODS:We conducted a proof-of-concept randomized controlled trial. The immediate group received a brief education session by a physical therapist, a Fitbit Flex, and four biweekly phone calls for activity counseling. The delayed group received the same intervention 2 months later. Participants were assessed at baseline (T0) and at the end of 2 months (T1), 4 months (T2), and 6 months (T3). Outcomes included (1) mean time on moderate-to-vigorous physical activity (MVPA ?3 metabolic equivalents [METs], primary outcome), (2) mean time on MVPA ?4 METs, (3) mean daily steps, (4) mean time on sedentary activities, (5) Knee Injury and Osteoarthritis Outcome Score (KOOS), and (6) Partners in Health scale. Mixed-effects repeated measures analysis of variance was used to assess five planned contrasts of changes in outcome measures over measurement periods. The five contrasts were (1) immediate T1-T0 vs delayed T1-T0, (2) delayed T2-T1 vs delayed T1-T0, (3) mean of contrast 1 and contrast 2, (4) immediate T1-T0 vs delayed T2-T1, and (5) mean of immediate T2-T1 and delayed T3-T2. The first three contrasts estimate the between-group effects. The latter two contrasts estimate the effect of the 2-month intervention delay on outcomes. RESULTS:We recruited 61 participants (immediate: n=30; delayed: n=31). Both groups were similar in age (immediate: mean 61.3, SD 9.4 years; delayed: mean 62.1, SD 8.5 years) and body mass index (immediate: mean 29.2, SD 5.5 kg/m2; delayed: mean 29.2, SD 4.8 kg/m2). Contrast analyses revealed significant between-group effects in MVPA ?3 METs (contrast 1 coefficient: 26.6, 95% CI 4.0-49.1, P=.02; contrast 3 coefficient: 26.0, 95% CI 3.1-49.0, P=.03), daily steps (contrast 1 coefficient: 1699.2, 95% CI 349.0-3049.4, P=.02; contrast 2 coefficient: 1601.8, 95% CI 38.7-3164.9, P=.045; contrast 3 coefficient: 1650.5, 95% CI 332.3-2968.7; P=.02), KOOS activity of daily living subscale (contrast 1 coefficient: 6.9, 95% CI 0.1-13.7, P=.047; contrast 3 coefficient: 7.2, 95% CI 0.8-13.6, P=.03), and KOOS quality of life subscale (contrast 1 coefficient: 7.4, 95% CI 0.0-14.7, P=.049; contrast 3 coefficient: 7.3, 95% CI 0.1-14.6, P=.048). We found no significant effect in any outcome measures due to the 2-month delay of the intervention. CONCLUSIONS:Our counseling program improved MVPA ?3 METs, daily steps, activity of daily living, and quality of life in people with knee osteoarthritis. These findings are important because an active lifestyle is an important component of successful self-management. TRIAL REGISTRATION:ClinicalTrials.gov NCT02315664; https://clinicaltrials.gov/ct2/show/NCT02315664 (Archived by WebCite at http://www.webcitation.org/6ynSgUyUC).

SUBMITTER: Li LC

PROVIDER: S-EPMC5952118 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Efficacy of a Community-Based Technology-Enabled Physical Activity Counseling Program for People With Knee Osteoarthritis: Proof-of-Concept Study.

Li Linda C LC Sayre Eric C EC Xie Hui H Xie Hui H Falck Ryan S RS Best John R JR Liu-Ambrose Teresa T Grewal Navi N Hoens Alison M AM Noonan Greg G Feehan Lynne M LM

Journal of medical Internet research 20180430 4

<h4>Background</h4>Current practice guidelines emphasize the use of physical activity as the first-line treatment of knee osteoarthritis; however, up to 90% of people with osteoarthritis are inactive.<h4>Objective</h4>We aimed to assess the efficacy of a technology-enabled counseling intervention for improving physical activity in people with either a physician-confirmed diagnosis of knee osteoarthritis or having passed two validated criteria for early osteoarthritis.<h4>Methods</h4>We conducted ...[more]

PMID: 29712630

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Project description:BackgroundCurrent evidence indicates physical activity wearables could support persons with knee osteoarthritis (OA) to be more physically active. However, recent evidence also identifies some persons with arthritis experience guilt or worry while using a wearable if they are not as active as they feel they should be. Questions remain around how persons with knee OA experience benefits or downsides using a wearable in their everyday lives. Better understanding is needed if wearables are to be incorporated in arthritis self-management in ethically aware ways.ObjectiveUsing an ethics lens, we aimed to describe a range of experiences from persons with knee OA who used a wearable during a physical activity counseling intervention study.MethodsThis is a secondary analysis of qualitative interviews nested within a randomized controlled trial. Guided by phenomenography, we explored the experiences of persons with knee OA following participation in a physical activity counseling intervention that involved using a Fitbit Flex and biweekly phone calls with a study physiotherapist (PT) in an 8-week period. Benefits or downsides experienced in participants' relationships with themselves or the study PT when using the wearable were identified using a relational ethics lens.ResultsInterviews with 21 participants (12 females and 9 males) aged 40 to 82 years were analyzed. Education levels ranged from high school graduates (4/21, 19%) to bachelor's degrees or above (11/21, 52%). We identified 3 categories of description: (1) participants experienced their wearable as a motivating or nagging influence to be more active, depending on how freely they were able to make autonomous choices about physical activity in their everyday lives; (2) some participants felt a sense of accomplishment from seeing progress in their wearable data, which fueled their motivation; (3) for some participants, sharing wearable data helped to build mutual trust in their relationship with the study PT. However, they also expressed there was potential for sharing wearable data to undermine this trust, particularly if this data was inaccurate.ConclusionsFindings provide an early glimpse into positive and negative emotional impacts of using a wearable that can be experienced by participants with knee OA when participating in a randomized controlled trial to support physical activity. To our knowledge, this is the first qualitative study that uses a relational ethics lens to explore how persons with arthritis experienced changes in their relationship with a health professional when using a wearable during research participation.

Project description:BACKGROUND:Physical activity (PA) reduces pain and improves functioning in people with knee osteoarthritis (OA), but few people with the condition meet recommended PA guidelines. Successful intervention strategies to increase PA include goal setting, action planning, self-monitoring, and follow-up feedback from a healthcare professional. Recently developed consumer wearable activity trackers allow users to set activity goals, self-monitor daily goal-progress, and provide feedback on goal attainment. It is hypothesized that a multi-component physiotherapist-led intervention that includes a short (40-min) education module, guided goal-setting and action planning, the use of a wristband activity tracker, and weekly follow-up phone calls will lead to increased PA outcomes. METHODS/DESIGN:Thirty-six participants will be recruited from the community for a two-group pilot randomized controlled trial with a stepped-wedge design using an intention-to-treat analysis. Computer-generated block randomization will be performed using varying block sizes and a 1:1 allocation ratio. The 4-week intervention will be delivered immediately (immediate-intervention group) or after a 5-week delay (delayed-intervention group). Outcome measures of pain and disability (Knee Injury and OA Outcome Score), disease self-management ability (Partners in Health Scale), and objective bouted moderate-to-vigorous PA and sedentary time (BodyMedia SenseWear Mini Armband) will be collected at baseline (week 0) and two follow-ups (weeks 5 and 10), for a total study duration of 11 weeks. Feasibility data relating to process, resource, management, and scientific elements of the trial will be collected. Outcome measure and feasibility data will be summarized, and an estimate of intervention efficacy will be obtained by regression model with planned comparisons. The trial began recruiting in February 2015. To date, 34 subjects have been recruited. DISCUSSION:This study will evaluate the feasibility and preliminary efficacy of a novel intervention to promote PA in people living with knee OA. The results will provide valuable information to inform a larger randomized trial to assess intervention effectiveness. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02313506 (registration date 8 December 2014). First participant randomized 20 February 2015.

Project description:Physical activity can improve health outcomes in people with knee osteoarthritis (OA); however, participation in physical activity is very low in this population.The objective of our study was to assess the feasibility and preliminary efficacy of the use of wearables (Fitbit Flex) and telephone counselling by a physical therapist (PT) for improving physical activity in people with a physician-confirmed diagnosis of knee OA, or who have passed 2 validated criteria for early OA.We conducted a community-based feasibility randomized controlled trial. The immediate group (n=17) received a brief education session by a physical therapist, a Fitbit Flex activity tracker, and a weekly telephone call for activity counselling with the physical therapist. The delayed group (n=17) received the same intervention 1 month later. All participants were assessed at baseline (T0), and the end of 1 month (T1) and 2 months (T2). Outcomes were (1) mean moderate to vigorous physical activity time, (2) mean time spent on sedentary behavior, (3) Knee Injury and Osteoarthritis Outcome Score (KOOS), and (4) Partners in Health Scale. Feasibility data were summarized with descriptive statistics. We used analysis of covariance to evaluate the effect of the group type on the outcome measures at T1 and T2, after adjusting for blocking and T0. We assessed planned contrasts of changes in outcome measures over measurement periods.We identified 46 eligible individuals; of those, 34 (74%) enrolled and no one dropped out. All but 1 participant adhered to the intervention protocol. We found a significant effect, with the immediate intervention group having improved in the moderate to vigorous physical activity time and in the Partners in Health Scale at T0 to T1 compared with the delayed intervention group. The planned contrast of the immediate intervention group at T0 to T1 versus the delayed group at T1 to T2 showed a significant effect in the sedentary time and the KOOS symptoms subscale, favoring the delayed group.This study demonstrated the feasibility of a behavioral intervention, supported by the use of a wearable device, to promote physical activity among people with knee OA.ClinicalTrials.gov NCT02313506; https://clinicaltrials.gov/ct2/show/NCT02313506 (Archived by WebCite at http://www.webcitation.org/6r4P3Bub0).

Project description:BackgroundThe global burden of osteoarthritis (OA) is steadily increasing due to demographic and lifestyle changes. The nervous system can undergo peripheral and central neuroplastic changes (sensitization) in patients with OA impacting the options to manage the pain adequately. As a result of sensitization, patients with OA show lower pressure pain thresholds (PPTs), facilitated temporal summation of pain (TSP), and impaired conditioned pain modulation (CPM). As traditional analgesics (acetaminophen and non-steroidal anti-inflammatory drugs) are not recommended for long-term use in OA, more fundamental knowledge related to other possible management regimes are needed. Duloxetine is a serotonin-noradrenalin reuptake inhibitor, and analgesic effects are documented in patients with OA although the underlying fundamental mechanisms remain unclear. The descending pain inhibitory control system is believed to be dependent on serotonin and noradrenalin. We hypothesized that the analgesic effect of duloxetine could act through these pathways and consequently indirectly reduce pain and sensitization. The aim of this mechanistic study is to investigate if PPTs, TSP, CPM, and clinical pain parameters are modulated by duloxetine.MethodsThis proof of concept study is a randomized, placebo-controlled, double-blinded, crossover trial, which compares PPTs, TSP, and CPM before and after 18 weeks of duloxetine and placebo in forty patients with knee OA. The intervention periods include a titration period (2 weeks), treatment period (60 mg daily for 14 weeks), and a discontinuation period (2 weeks). Intervention periods are separated by 2 weeks.DiscussionDuloxetine is recommended for the treatment of chronic pain, but the underlying mechanisms of the analgesic effects are currently unknown. This study will investigate if duloxetine can modify central pain mechanisms and thereby provide insights into the underlying mechanisms of the analgesic effect.Trial registrationClinicalTrials.gov NCT04224584 . Registered on January 6, 2020. EudraCT 2019-003437-42 . Registered on October 22, 2019. The North Denmark Region Committee on Health Research Ethics N-20190055. Registered on October 31, 2019.

Project description:BackgroundA patient-engagement and pathway-management program for patients undergoing primary total hip and knee replacement was evaluated. Health-service and multimedia features supported by technology were integrated with existing enhanced recovery after surgery (ERAS) practices. The primary objective was to demonstrate the impact on length of stay. The secondary objective was to assess the impact on clinical, patient-focused, and financial outcomes.MethodsTwo thousand and eighty consecutive patients undergoing primary total hip replacement (n = 1,034) and total knee replacement (n = 1,046) were classified into "pre-program" (retrospectively assessed [n = 1,038]) and "program" (prospectively assessed [n = 1,042]) cohorts. Patients in the program cohort were subdivided according to those who were eligible for criteria-based outreach support (OS) (n = 401) and those who were ineligible for this service (NOS) (n = 641). Clinical outcomes were assessed for all patients, and patient-focused outcomes were assessed for a subset (n = 223).ResultsThe mean reduction in length of stay ranged from 20% (1.2 days) to 42% (2.5 days) following total hip replacement and from 9% (0.6 day) to 31% (2 days) following total knee replacement (p < 0.001). Clinical outcomes (readmissions, complications, emergency department re-attendance rates) were not significantly negatively impacted. The Oxford Hip Score had numerically larger improvement after total hip replacement in the OS group than in the pre-program group (4.1-point increase), and the Oxford Knee Score had numerically larger improvement after total knee replacement in the NOS group than in the pre-program group (0.8-point increase). The patients in the program cohort (either OS or NOS) rated overall health gain as higher than those in the pre-program cohort (gain in numerical rating scale, 1.4 points for patients managed with total hip replacement, 0.6 points for patients managed with total knee replacement). Older patients and those with higher comorbidity indices benefited most with respect to length of stay and multiple clinical outcomes. Patient experience was significantly improved across domains (p < 0.001 to p = 0.003). Potential savings for patients managed with total hip replacement (£401.64 [$267.76] per patient) exceeded estimated program charges of £50 [$33.33] to £60 [$40] per patient, whereas the potential savings for patients managed with total knee replacement (£76.67 [$51.11] per patient) were sufficient to achieve a reduction of total system costs.ConclusionsTechnology-enabled programs may deliver enhanced care at lower costs for patients undergoing lower-limb arthroplasty. Shorter durations of inpatient stay without a negative impact on clinical outcomes and improved patient-focused outcomes and experience can deliver substantial value that can be especially beneficial for older patients and those with greater medical complexity.Level of evidenceTherapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

Efficacy of a Community-Based Technology-Enabled Physical Activity Counseling Program for People With Knee Osteoarthritis: Proof-of-Concept Study.

Publications

Efficacy of a Community-Based Technology-Enabled Physical Activity Counseling Program for People With Knee Osteoarthritis: Proof-of-Concept Study.

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