ABSTRACT
Purpose: Disability in knee osteoarthritis (KOA) is known to be largely due to pain, the mechanism of which is complex and multidimensional with alterations in nociceptive processing in the peripheral and central nervous system (CNS) leading to persistent pain. Current clinical practice guidelines for KOA provide strong recommendations for education and exercise including land-based or mind-body approaches. However, individually these strategies are only moderately effective. One potential reason for this is a lack of understanding of their underlying mechanisms and how their combination might impact nervous system modulation. Neuromuscular exercise is known to improve lower extremity strength. Mind-body approaches as well as pain neuroscience education (PNE) are uniquely positioned to potentially reverse CNS adaptations by inducing positive neuroplastic changes and improving descending modulation of pain resulting in decreased pain. To our knowledge, neuromuscular exercise, mind-body techniques, and PNE have not been studied in combination. We therefore aimed to establish the feasibility of an intervention consisting of these three elements referred to as Pain Informed Movement (PIM). The results of this study will inform necessary modifications for a two-arm pilot randomized controlled trial (RCT). Method(s): This study was a single-arm feasibility trial with a nested qualitative component and the primary feasibility outcome of complete follow up. Inclusion criteria: age >= 40 years, KOA clinical diagnosis or people fulfilling the NICE diagnostic criteria, and average pain intensity >=3/10 on the numeric pain rating scale. PIM consisted of twice weekly in-person exercise sessions and a third home exercise session for 8 weeks. In addition, PNE, provided as online videos, covered the following topics: purpose of pain, neurophysiological changes associated with pain, movement guidelines when pain persists, mind-body techniques to impact neurophysiology and support moving with ease that included breath awareness and regulation, muscle tension regulation, awareness of pain related thoughts and emotions, and relaxation. The mind-body techniques and the PNE topics were implemented during the group exercise sessions that included evidence-based neuromuscular exercises aimed at improving sensorimotor control and functionality of the knee joint. Participants completed questionnaires and in-person assessments at baseline and at program completion. Assessments included weight and height, chair stands as a measure of functional leg strength, and conditioned pain modulation to assess efficiency of the descending modulatory pathways. Participants also had their blood drawn to monitor changes in brain derived neurotrophic factor (BDNF), a marker of neuroplasticity. Questionnaires included the Pain Catastrophizing Scale, Hospital Anxiety and Depression Scale, the Knee Injury and Osteoarthritis Outcome Score - function and pain subscales, Chronic Pain Self Efficacy scale, pain intensity rated in the past 24 hours, the past week, and worst pain in the past 24 hours. Secondary feasibility outcomes included acceptability of the intervention, burden of assessments, recruitment rate, compliance rate, adherence rate, and self-reported adverse events. Feasibility findings were evaluated against a-priori success criteria. In the qualitative component, participants were invited to an online focus group and were asked about their experience and perceptions of the program. Interview recordings were analyzed using thematic content analysis to identify suggestions for program modification. Result(s): In total, 19 participants (mean age 63.3 years (SD 10.5), 73% female) were enrolled, with a complete follow up rate of 74% (n=14) for our primary objective, indicating that modifications would be needed to proceed. Of the 5 dropouts, only one was study related. We will be adding additional inclusion criteria of: ability to get up and down from the floor independently, and no use of mobility aids. Adherence to in-person treatment sessions was 91%, hich indicates proceeding with the protocol for the next phase (i.e., pilot RCT). Some absences were due to unmodifiable factors (e.g., COVID-19). We will make protocol amendments for the purpose of improving the adherence rate to include 'no planned absences'. All other success criteria were met: recruitment rate, compliance to exercise sessions, program acceptability, duration, frequency, and delivery, likelihood of recommending the program to others and taking the program again, burden, and adverse events (Table 1). Analysis of the focus groups revealed that the video content pertaining to the mind-body techniques would benefit from on screen demonstrations by the instructor to assist with participants' execution of breath and muscle tension regulation. The majority of participants improved in most of the physical assessment outcomes and questionnaires (Table 2). Conclusion(s): The PIM program is feasible, acceptable, not burdensome, does not cause adverse events, and had an excellent compliance rate. Minor modifications are needed to optimize enrolment and adherence rates. Although improvements in pain, function, and psychological measures were observed, the feasibility nature of this study precludes any conclusions regarding efficacy. A pilot two-arm RCT will be conducted to establish the feasibility and explore potential effects of PIM when compared to conventional neuromuscular exercise and standard OA education. [Formula presented] [Formula presented]Copyright © 2023
ABSTRACT
Knee osteoarthritis (KOA) among obese people is a common joint pain with loss of physical functioning, disability and reduction in quality of life QoL). This study aimed to compare the effect of aquatic and Thera-band exercise on pain intensity and QoL among obese people with KOA. A total of 45 KOA participants with BMI ≥ 27.5 kg.m-² were randomly recruited and randomly assigned into three groups;aquatic (AQG), Thera-band exercise (TBG) and control (CG);carried out the exercise program, two times weekly, 60 minutes per session, for eight weeks. Quality of life was measured using modified KOOS questionnaire with five sub-domains;pain, symptoms, activities of daily living (ADL), sports/ recreation and knee-related QoL. The results showed no significant difference in age, weight, BMI, and KOA involvement background in all groups. The MANCOVA results displayed a significant interaction of group×time effect on all sub-domains of QoL;pain, symptoms, ADL, sports/recreation and total QoL. In addition, pairwise comparisons between groups among QoL sub-domains revealed that there was significant difference between AQG and TBG in all dimensions of QoL (pain, symptom, ADL and knee-related QoL) exception in sports/recreation domain. For overall aquatic exercise could reduce pain and improve QoL greater that Thera-band exercise after eight weeks of the exercise program. As a conclusion, this progressive aquatic exercise program had a superior effectiveness to reduce all dimensions of QoL, although Thera-band exercise cannot be ignored as an effective, simple and inexpensive method to create a self-exercise program among obese people who suffering from KOA.
ABSTRACT
Purpose: Osteoarthritis (OA) is a chronic and disabling condition affecting morbidity and mortality. Despite its high prevalence and the availability of international management guidelines, nearly half of patients do not receive recommended treatments. OA Management Programs (OAMPs) are an alternative care model to reduce barriers and enhance the receipt of evidence-based care. This study was designed to evaluate the fidelity and feasibility of an OAMP in a United States academic medical center and understand its patients' baseline characteristics. Methods: The OAMP, which opened on July 1, 2017, is focused on knee and hip osteoarthritis. A multi-disciplinary group, including patients with OA, designed the clinic model and operations based on international OAMP implementation recommendations considering local factors. The intended treatment dose was 1-6 appointments over 4-12 months with no more than two months between visits. At each appointment, patients had the opportunity to meet with a care team comprised of a medical provider (physician or advanced practice provider), registered dietitian, physical therapist, and mental health counselor. All providers had completed OA clinical competency training. Telemedicine video visits were also available after June 2020 due to the COVID-19 pandemic. Patients are asked to complete the patient questionnaires before their visit through a patient portal in the electronic health record. They are also provided with a tablet computer to complete the VR-12 and the HOOS and/or KOOS while in the clinic waiting room. For this study, a database was created for all adult patients who had at least one clinic visit from July 1, 2017, to January 15, 2021. Data was collected by an electronic health record data pull and a manual audit of visit notes. Primary outcomes related to clinic feasibility and fidelity included clinic operations and expansion, treatment duration, and number and type of appointments attended. Secondary outcomes included patients' baseline characteristics. Results: The 938 eligible patients attended an average of 2.7 visits over a mean of 114.4 days (±5.9). Patients utilized the OAMP differently: 371 (39.5%) of patients attended 1 visit, 348 (37.1%) attended 2-3, and 232 (24.7%) attended 4 or more. A total of 175 (18.66%) completed at least one telemedicine visit. Patient referrals came predominantly from primary care (61%%) and orthopedics (20.3%);8.6% were self-referred. The average time between seeking care and the first appointment is just over six weeks. Due to patient demand, the program has expanded from seeing six patients per week to seeing more than 40 patients per week. The expansion has required hiring and training an increased number of clinicians, starting with four clinicians in different specialties to 11 clinicians. The average patient was 62.2 years (±10.2), and most were female (72%). Nearly all were Caucasian (91.3%). Medicare (51.4%) was the most common type of insurance, followed by commercial insurance (38.3%). Half of the patients were employed (49%), while 32% were retired. At the initial visit, the average BMI was 40.9 (±10). The average Charlson Comorbidity Index score (CCI) was 2.1 (±1.3), indicating moderate severity of comorbid conditions. The baseline pain rating was moderate at 4.44 (±2.37) on a 1-10 pain scale. The Knee Injury and Osteoarthritis Outcome Score (KOOS) and Hip Injury and Osteoarthritis Outcome Score (HOOS) pain scores were 47.9 (±18) and 44.9 (±23.6), respectively showing moderate baseline levels of pain. Veterans-Rand 12 scores were low at the initial visit. The VR-12 physical and mental subscales were 25.66 (±7.35) and 48.15 (±10.76) lower than expected for an adult population. The average number of repetitions obtained from the 30-second chair rise test was 10.65 (±3.49), which is lower than age and gender norms. The completion rate of self-administered patient questionnaires was low, with less than half of patients completing all questionnaires at the initial visit. Conclusions: Baseline data reveals patie ts with high levels of pain, low function, and multiple comorbid conditions who are willing to attend multiple visits. The program has continued to expand to meet increased patient demand. Patient utilization of the clinic varied, with some patients attending only one appointment and others returning numerous times. Despite being invited back within two months, a subset of patients returned for a second appointment more than six months after their initial appointment. Completion rates of the self-questionnaires (HOOS/KOOS, VR-12) were low despite having options of how to complete these. The low completion rate indicates that instruments should be selected judiciously with careful consideration for which should be administered at every clinic visit. Clinic operations and growth are feasible with variable fidelity. The next steps will be an evaluation of patient utilization of the clinic and its impact on patients outcomes.
ABSTRACT
Purpose: Osteoarthritis (OA) affects more than 300 million people worldwide with the knee and hip joints among the most clinically prevalent. Pain, stiffness, and physical disability are hallmark symptoms that impair quality of life. Good Life with osteoArthritis from Denmark (GLA:D®) is an evidence-based program providing education and exercise-therapy for people with knee and hip OA, now offered in 8 countries. A key barrier to GLA:D® is the need to attend 14 in-person sessions over 8-weeks, particularly for those in rural areas or with substantial occupational or family caring responsibilities. In the COVID-19 pandemic we expanded implementation support for GLA:D®in Australia to provide it via telehealth. The aim of this mixed methods project was to evaluate the implementation of GLA:D® via telehealth in Australia using the Reach, Effectiveness, Adoption, Implementation, and Maintenance Qualitative Evaluation for Systematic Translation (RE-AIM QuEST) framework. Methods: Quantitative: People with knee or hip OA who reported completing GLA:D® via telehealth-only or a hybrid model of in-person and telehealth (minimum 3 telehealth sessions) at 3-month follow-up from March 2020-October 2021 were identified from the GLA:D®Australia registry. RE-AIM dimensions were examined descriptively. For the effectiveness domain mean differences [MD, (95% confidence intervals (CI)), effect size (ES)] from baseline to 3-month follow-up were calculated for pain (visual analogue scale, 0-100) and joint-related quality of life (knee injury and osteoarthritis outcome score or hip disability and osteoarthritis outcome score -quality of life sub-scales). Participants rated perceived recovery on a global rating of change (scale -3 to 3;1-3=recovered) and how satisfied they were with the GLA:D® program (scale 1-5;4,5=satisfied) at 3-month follow-up. Qualitative: One-on-one semi-structured interviews were conducted with 23 GLA:D® trained physiotherapists (n=12 telehealth adopters;n=11 non-adopters) from diverse (private/public practice, urban/rural) settings. Interviews were transcribed and analysed using a reflexive thematic approach guided by the RE-AIM QuEST framework. Results: Reach: 138 people (39 telehealth-only and 99 hybrid model;69% female) completed GLA:D.® Mean (SD) age and BMI were 64 (9) years 29.8 (5.5) kg/m2, respectively. Key themes on patient barriers and enablers for telehealth reach were technology literacy and access, personal preference and perceived value of telehealth, and availability of exercise equipment. Pandemic restrictions limiting access to in-person GLA:D® was an enabler. Effectiveness: For telehealth-only, average pain [MD=-10 (95%CI=-16, -4), ES=-0.54] and joint-related quality of life [MD=9 (95%CI=3, 14), ES=0.51] improved significantly. This was similar for hybrid model with average pain [MD=-11 (95%CI=-16, -6, ES=-0.43)] and joint-related quality of life [MD=12 (95%CI=8, 16, ES=0.65)] also improved. At 3-months, 81% of participants reported recovery and 88% were satisfied with GLA:D®. Most physiotherapists who adopted GLA:D® telehealth believed it was as effective as in-person for most patients and felt patients were better able to continue exercising at home upon completion. Adoption: 92 physiotherapists (74 health services) delivered GLA:D® via telehealth. Most physiotherapists who had adopted GLA:D® via telehealth stated it had become a normal part of their practice. Barriers to adoption included preferring, and greater confidence with providing, in-person GLA:D®. Implementation: Both education sessions were attended by 70% (n=96) of participants and 91% (n=125) attended more than 10 exercise-therapy sessions. GLA:D® telehealth implementation involved program modifications, including to assessment, exercise instruction, equipment modifications, and reduced fee structures. Maintenance: GLA:D® telehealth participants completed 3-month follow-ups throughout the entire study timeframe, with 16 (12%) in the final 2 months of evaluation, indicating ongoing participant engagement. Physio herapists stated GLA:D® telehealth was an opportunity for increased program access to immunocompromised, rural, and working patients. Barriers to sustainability identified included lack of personnel capacity, low patient demand, and a need for future telehealth training and support. Conclusions: Telehealth delivery of GLA:D® in Australia during the pandemic was most used as part of a hybrid model, combined with in-person delivery. Patient outcomes following GLA:D® via telehealth were comparable to published data related to in-person delivery, indicating it is an effective method to implement group-based care for OA. Yet, implementation was limited, impeded by low perceived value by patients and lack of confidence and training of physiotherapists. This evaluation will guide new strategies and training to support GLA:D via telehealth as a viable mode of program delivery in the future in Australia and internationally.
ABSTRACT
Purpose: Knee Osteoarthritis (KOA) is a leading cause of physical disability worldwide. Individuals who suffer from KOA experience pain, reduced mobility, and lower quality of life. Considering the upward trend in KOA diagnoses, the economic burden of knee replacement, and the surgical backlog from COVID-19, the need for alternative conservative treatments is pressing. Bracing is an economical and accessible form of conservative treatment. Traditional KOA braces only offload one knee compartment. However, over 50% of the KOA population suffers from cartilage damage in multiple compartments. The Levitation™ “Tri-Compartment Offloader” (TCO) knee brace contains embedded liquid springs that provide flexion support and extension assist to simultaneously offload joint forces in all three knee compartments. Similar to the effect of weight loss, biomechanical studies have demonstrated that the TCO provides clinically relevant reductions in tibiofemoral and patellofemoral joint contact forces ranging between 30-50%. However, there is a need to validate whether the TCO improves real world outcomes in KOA patients. Therefore, the current objective is to examine the influence of a TCO brace on knee pain and function in a population suffering from KOA. Methods: Individuals with KOA who purchased the TCO are being enrolled in the ongoing study following informed consent (n=113). Participants receive 4 online surveys administered using Qualtrics (USA). The first survey is completed before brace wear commences (0-months), and follow-up surveys are scheduled after 1-month, 3-months and 9-months of TCO brace wear. The surveys contain validated questionnaires including the Visual Analog Scale (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score (KOOS), EuroQol 5D-5L, International Physical Activity Questionnaire, Orthotics and Prosthetics Users Survey;as well as custom questionnaires to collect demographic information. This preliminary analysis includes 54 participants who completed the 1-month and 3-months surveys (mean age 55.7±9.1 yrs;43 male). Variables of interest include knee pain (VAS) and function (KOOS). Pain was assessed during four common activities: 1) walking on a flat surface (Flat Walking);2) rising from seated (Sit & Stand);3) going up and down stairs (Stairs);and 4) Squatting. A VAS pain score of 0 represents no pain, and 100 represents the worst pain imaginable. KOOS domains included: 1) Pain;2) Symptoms;3) function in activities of daily living (ADL);4) function in sport and recreation (S&R);and 5) knee-related quality of life (QoL). A KOOS score of 0 represents severe problems, and 100 represents no problems. Statistical analysis was conducted using SPSS (IBM, USA). Pain (VAS score) between timepoints was assessed using four one-way repeated measures ANOVAs with Bonferroni correction for multiple comparisons (α = 0.0125). Post-hoc analyses were used to compare timepoints. Effects of TCO use on knee function were assessed using Wilcoxon's signed-rank test with Bonferroni correction (α = 0.01). Results: Participants wore the TCO for an average of 5.1±3.4 hours/day, and 5.2±1.8 days/week at 1-month and 5.0±3.1 hours/day and 4.9±1.7 days/week at 3-months. One participant did not complete the 1-month survey. Further, two participants did not provide complete VAS responses (Table 1) and a number of participants did not provide answers to all KOOS domains (Table 2). Significant effects of TCO use on pain were observed during all activities (p<0.001) (Figure 1, Table 1). Post-hoc analyses indicated significantly decreased pain for all activities at 1-month (p <0.001) and 3-months (p-value range 0.001-0.01) compared to baseline (0-months). There were no significant differences in pain between 1-month and 3-months of TCO use (p-value range 0.318-1). The scores for all 5 domains of KOOS increased after 1-month and 3-months of TCO brace wear compared to baseline. TCO use resulted in a significant increase in ADL (0-1 months: p<0.001;0-3 months: p<0.001), Pain (0-1 months: p<0.001), and S&am ;R (0-1 months: p<0.002) (Figure 2, Table 2). [Formula presented] [Formula presented] [Formula presented] [Formula presented] Conclusions: This study demonstrates that the TCO brace significantly decreased knee pain for KOA patients when worn during common daily activities. The mean difference in pain scores after 1-month of TCO wear was greater than the minimally clinically important difference (-19.9mm) for all activities suggesting a clinically significant improvement in pain. These significant reductions in pain were maintained after 3-months of TCO wear, demonstrating continued pain management benefits at 3-months. This suggests that the TCO is an effective conservative treatment option over a moderate period of time. Brace usage data indicated good compliance and consistent duration of brace wear between 1-month and 3-months, which could be a result of the continued reduction in knee pain. An improvement in all 5 dimensions of KOOS was also observed, with significant improvements in Pain, ADL, and S&R after 1-month of wearing the TCO. These findings indicate that the Levitation™ TCO brace has a strong potential to manage pain and improve knee function for patients suffering from KOA. Future work includes continued data collection and investigating the effects of the TCO on pain and function in the KOA population over a longer time period.
ABSTRACT
Purpose: Knee osteoarthritis (OA) is an inflammatory disease, with a probable role for IL-1β. Calcium and urate crystals may promote OA by activating the NLRP3 inflammasome to produce IL-1β. Colchicine is a well-tolerated anti-inflammatory agent that inhibits the inflammasome and suppresses IL-1β. Studies examining the impact of colchicine on knee OA have yielded varying results, with some reporting pain relief, others improvement of inflammatory markers, and none assessing synovial effusions. We report the interim, blinded results of our ongoing colchicine trial for knee OA. Methods: CLOAK is a randomized, double-blind, placebo-controlled trial of colchicine (0.8 mg daily for 3 months) (Figure 1). Subjects are ≥ 40 years of age, with symptomatic knee OA, Kellgren-Lawrence grade 2 or 3 radiographs, and willingness to forego other anti-inflammatory therapy during the trial. The primary outcomes are the difference in knee pain improvement between treatment and placebo groups by Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale (VAS). Secondary outcomes include KOOS axes pre- to post-treatment, mean doses of analgesics used, and changes in plasma and peripheral blood leukocyte inflammatory markers. Patients undergo knee ultrasound (US) pre- and post-treatment to assess for synovitis and effusions. We aspirate synovial fluid when appropriate, and will analyze all available blood and synovial samples after study completion. Results: To date, 360 potential subjects have been contacted, 69 screened, and 59 enrolled (target enrollment 120). Among the first 48 who completed the study, 52.2% were male, 60.4% White, 27% Black, 6.3% Asian and 6.3% other, with mean BMI of 27.5 kg/m2 and age of 66.9 years. The mean VAS pain score among all completing participants (receiving either colchicine or placebo) declined by 1.0 units in the index knee, and mean KOOS scores improved for symptoms, pain, activities of daily living (ADL), sports activity, and quality of life (QOL). Overall 29 (60.4%) demonstrated VAS improvement (mean decline 2.2) whereas 19 (39.6%) demonstrated no change or worsening. Most subjects whose VAS improved also showed improvement in KOOS: mean symptoms by 9.6, pain by 12.8, ADL by 15.2, sports activity by 9.1 and QOL by 10.2 units. The subsets of patients with baseline VAS ≥6 and baseline KOOS ≤60 (i.e., more severe disease) showed significantly more 3-month KOOS pain improvement than those with milder disease, even with the blinded inclusion of placebo (Figure 2). All subjects underwent baseline and post-treatment US, except for 6 who received their final visit by telephone and missed the second US because of COVID-19 restrictions. KOOS improvement was unaffected by baseline effusion status. Among 24 patients with VAS improvement over 3 months, 5 had baseline synovial effusions ≥4 mm (in longitudinal and transverse views) and all effusions were smaller post-treatment. Conclusions: The results of this blinded analysis support a potential benefit of colchicine for pain, function and effusion in subjects not taking other anti-inflammatory agents. Enrollment is ongoing and the study will be unblinded and fully analyzed after completion. Supported by an investigator-initiated grant from Hikma Pharmaceuticals. [Formula presented] [Formula presented]
ABSTRACT
Purpose: Current walking interventions for people with knee osteoarthritis (OA) focus on either reducing knee joint loading or on increasing physical activity. There is a need for interventions that could address both quality and quantity of walking for people with knee OA. The goal of this randomized controlled trial (clinicaltrials.gov # NCT03064139) was to determine the feasibility of a mindful walking intervention to improve quality and quantity of walking in people with knee OA. Methods: Individuals with symptomatic knee OA were recruited from the community using advertisements. Study criteria are shown in Table 1. [Formula presented] During enrollment, the more symptomatic knee, or a knee selected at random in case of equal symptoms, was designated as the study knee. After the baseline visit, participants were randomized to either a mindful walking group (MWG) or an attention-matched self-management group (SMG). Participants in both groups received 11 intervention sessions delivered over a 6-month period (4 in 1 st month, 2 each in 2nd and 3rd months, 1 each in 4th, 5th, and 6th months). Interventions were delivered via in-person groups (4-10 in each group) and each session was 1.5-3 hours in duration. For MWG, a certified instructor provided training in mindful walking that includes whole-body movement retraining and mindful body-awareness skill building. Biomechanical elements include: shorter stride length, higher cadence, greater toe-in, and more aligned posture. Participants were coached to progressively increase their mindful walking activity each week. Mindfulness elements include mindful body-awareness skills to increase sensitivity and awareness of deviations from the taught techniques. The approach is based on “ChiWalking®” so called because the movement approaches are drawn in part from T’ai Chi. For SMG, a researcher delivered a curriculum consisting of education and self-management techniques (e.g., importance of physical activity and exercise, nutrition, weight-management, etc.). This information was also provided to MWG in a condensed form. Gait analyses and physical performance tests were completed at baseline and 6-months. Physical activity was assessed using a commercial wrist-worn activity monitor (Charge 3, Fitbit Inc, San Francisco, CA). Participant-reported outcomes (PROs) were completed at baseline and every 3-months. Participants were remotely followed for an additional 6-months after the end of the intervention. Given the feasibility nature of the study, primary outcomes included recruitment, adherence, retention and number of adverse events. Secondary outcomes included peak external knee adduction moment [KAM], daily step count, Knee injury and osteoarthritis outcome score (KOOS) Pain, Five Facet Mindfulness Questionnaire (FFMQ), Arthritis Self-Efficacy Scale (ASES), 30-second chair stand test (30STS), 40-meter fast paced walk test (40FPW), and Stair Climbing Test (SCT). Analyses were conducted on intention-to-treat basis with all randomized participants included and missing values were not imputed. Results: Participants were recruited between March 2019 and January 2020. During this period, ∼450 individuals completed pre-screening questionnaires (∼41 per month), 66 completed in-person screening visits, 47 were enrolled, and 44 were randomized (Table 2). Interventions for 19 participants were interrupted, delayed for 3-months, and then transitioned to virtual format due to the COVID-19 pandemic. While the original recruitment goal was 62, the trial was halted earlier due to COVID-19. [Formula presented] Attendance is shown in Table 3. On average, MWG group attended 63% of the sessions vs. 70% in the SMG group. Among those who attended at least 1 session, MWG group attended 69% vs. 77% for SMG. Among those who attended at least 3 sessions, MWG group attended 75% vs. 84% for SMG. Post-intervention, 65% (n=15) and 87% (n=20) of MWG completed the in-person visits and PROs, respectively. In SMG, 81% (n=17) completed in-person visits and PROs. At 12-months, 91% (n=21) and 71% (n 15) completed the PROs for MWG and SMG, respectively. [Formula presented] Participant feedback at 6- and 12-months showed that the intervention was acceptable (Table 4). There were no serious adverse events related to the intervention in either group. Within group and between group differences for secondary outcomes are shown in Table 5. [Formula presented] [Formula presented] Conclusions: Our benchmarks were recruitment over 1.5 years, attendance of 75% in MWG group, and retention of 80% of participants at 6-months. While all of these benchmarks were negatively impacted by COVID-19, the recruitment rates over the period studied, adherence in those who attended at least 3 sessions, and retention for some secondary outcomes were acceptable. Participants in both groups found the interventions helpful, enjoyable, and rated it highly. At 12-month follow-up, MWG participants continued to practice mindful walking 1-2 days a week. Between group differences for secondary outcomes were small. Given the feasibility nature of the study, conclusions regarding efficacy cannot be made and larger trial would be needed. Our results show that our methods are appropriate for conducting such a larger trial.
ABSTRACT
Purpose: The COVID-19 pandemic has accelerated the adoption of digital health technologies for remote monitoring of participants in clinical trials, including measuring physical function. For trials in people with knee osteoarthritis (OA), standardized measures of function such as gait and chair stand are considered important outcomes. Wearable sensors have the potential to monitor these outcomes remotely. However, the reliability of wearable sensor metrics of gait and chair stand in participants’ homes and agreement between these metrics collected in laboratory and at-home have not been reported to date. Hence, our objective was to assess the reliability of wearable sensors for remote monitoring of gait and chair stand in people with knee OA. Methods: We used data from a substudy (n=20) embedded within an ongoing, single-arm clinical trial of an exercise intervention in people with knee OA (clinicaltrials.gov NCT04243096). Key inclusion criteria were age ≥ 50, BMI ≤ 40 kg/m2, physician diagnosed knee OA, score ≥ 3 on weight-bearing questions from the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale in the index knee, and ability to walk for 20 minutes without assistance. Key exclusion criteria included other major health conditions;prior, current, or planned major knee OA treatment;prior surgeries for knee OA;and contraindications to exercise. All assessments took place prior to initiation of the intervention. Participants completed two visits, an in-person lab visit and a remote at-home visit. The order of these visits was randomized across participants, with participants completing both visits between 1 and 20 days of each other. For the remote visit, participants were provided a wearable system consisting of three inertial sensors (Opal, APDM, Portland, OR, USA), two cones connected by a 7-meter rope, and an armless chair. Identical equipment was used during the in-person lab visit. During the remote visit, researchers guided the participants via video conference. Participants self-applied the sensors on each foot and on the lower back. They performed two trials each of a standardized gait task (self-selected walk for two laps of a 7-meter path defined by the cones and rope totaling 28 meters of walking) and chair stand task (five chair stands as quickly as possible with arms across the chest) in their home. Then, the participants removed the sensors, waited 15-minutes, re-applied the sensors, and performed two more trials of each task. At the end of the remote visit, participants completed a survey on their experience. During the in-person lab visit, participants performed two trials of the same tasks after a researcher placed the sensors on the participants. Spatiotemporal metrics of gait function and duration of chair stand were extracted from the sensor data using software (MoveoExplorer) provided by the sensor manufacturer. The mean of sensor metrics across each set of two trials were used in the analyses. We used Pearson’s correlation R2 and the intra-class correlation coefficients (ICC) to determine the correlation and the test-retest reliability of sensor metrics from the two repetitions of the tasks during the remote visit. We used ICCs and Bland-Altman plots and their 95% limits of agreement to examine agreement between sensor metrics from the remote (first two trials) and lab visits. Results: Participant characteristics are shown in Table 1. All ICCs were good to excellent (between 0.85 and 0.96) for the test-retest reliability during the remote visit and R2 ranged between 0.81 and 0.95 (Table 2, Figure 1). ICCs were moderate to excellent (between 0.63 and 0.91) for agreement between remote and lab visits (Table 2). Bland-Altman plots showed small bias in all metrics due to participants walking slightly faster during the lab visit compared to the remote visit (Figure 2). Participants were highly accepting of the remote visit (Table 3). Conclusions: In this cohort of people with knee OA who had moderate pain and disability, our method of estimating gait and chair stand fu ction remotely was found to be reliable, feasible, and acceptable. Wearable sensors could be used to remotely monitor gait and chair stand function in participant’s natural environments at a lower cost, reduced participant and researcher burden, and greater ecological validity overcoming many limitations of lab visits. Hence, our approach could be used in future clinical trials of people with knee OA. [Formula presented] [Formula presented] [Formula presented] [Formula presented] [Formula presented]