Virtual Mind-Body Program for Obese Knee Osteoarthritis Patients with Comorbid Depression: Development and Feasibility Pilot (Preprint)

2021 ◽  
Author(s):  
Ryan A. Mace ◽  
Jonathan Greenberg ◽  
Nicole Lemaster ◽  
Brooke Duarte ◽  
Terence Penn ◽  
...  

BACKGROUND Knee osteoarthritis (KOA) is the most common joint disorder in the U.S. and a leading cause of disability. Depression and obesity are highly comorbid with KOA and accelerate knee degeneration and disability through biopsychosocial mechanisms. Mind-body physical activity programs can engage biological, mechanical, and psychological mechanisms to improve outcomes in KOA, but such programs are not currently available. OBJECTIVE Here, we report on a mixed-methods study to adapt a mind-body activity program for the unique needs of patients with KOA, depression, and obesity (GetActive-OA) delivered via live video. METHODS Participants were adults (age ≥ 45) from rural Kentucky with obesity (BMI ≥ 30 kg/m2), idiopathic KOA with mild to moderate radiographic changes, and elevated depressive symptoms (PHQ-9 ≥ 10) recruited from two orthopedic centers. In Phase 1, we developed GetActive-OA and the study protocol using qualitative focus group feedback from the study population (N = 9; 2 focus groups, 90 minutes) and multidisciplinary expertise from clinical psychologists and orthopedic researchers. In Phase 2, we explored the initial feasibility, credibility, and acceptability of GetActive-OA, live video delivery, and study procedures via an open pilot with exit interviews (N = 5, 1 group). This research was guided by the NIH Model Stage 1A. RESULTS Phase 1 qualitative analyses revealed nuanced information about: 1) challenges with coping and increasing activity, 2) high interest in a mind-body activity program, 3) program participation facilitators (flexibility with technology) and barriers (amotivation, forgetfulness), and 4) perceived challenges with data collection procedures (blood and urine samples, homework). Phase 2 quantitative analyses showed that GetActive-OA met most a priori feasibility markers (e.g., feasibility of recruitment, acceptability, expectancy, credibility, adherence, and program satisfaction). Adherence to ActiGraph wear and collection of blood samples was low. Participation in GetActive-OA was associated with signals of improvements in pain, KOA symptoms, depression, anxiety, pain catastrophizing, self-efficacy, and general coping. Qualitative exit interviews confirmed quantitative findings and provided valuable information to optimize the program and protocol. CONCLUSIONS Patients with KOA, depression, and obesity from rural Kentucky are interested in a virtual mind-body activity program this comorbidity GetActive-OA shows promise, but the program and protocol require further NIH stage 1 refinement before formal efficacy testing (NIH model stage II). INTERNATIONAL REGISTERED REPORT RR2-10.1016/j.conctc.2021.100720

2021 ◽  
Author(s):  
James D Doorley ◽  
Ryan A Mace ◽  
Paula J Popok ◽  
Victoria A Grunberg ◽  
Anya Ragnhildstveit ◽  
...  

Abstract Background and Objectives Chronic pain (CP) and cognitive decline (CD) are highly co-morbid and debilitating among older adults. We iteratively developed Active Brains–Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. Research Design and Methods Older adults (age ≥ 60) with CP and CD (2 cohorts) completed eight weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. Results AB-F met a-priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. Discussion and Implications Results provide evidence for the feasibility of our completely remote study, and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial.


10.2196/25351 ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. e25351
Author(s):  
Ryan A Mace ◽  
James D Doorley ◽  
Paula J Popok ◽  
Ana-Maria Vranceanu

Background Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. Objective We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. Methods This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). Results The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). Conclusions Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic. Trial Registration ClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183 International Registered Report Identifier (IRRID) DERR1-10.2196/25351


2020 ◽  
Author(s):  
Ryan A Mace ◽  
James D Doorley ◽  
Paula J Popok ◽  
Ana-Maria Vranceanu

BACKGROUND Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. OBJECTIVE We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. METHODS This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). RESULTS The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). CONCLUSIONS Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic. CLINICALTRIAL ClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/25351


2021 ◽  
pp. rapm-2020-102258
Author(s):  
Asokumar Buvanendran ◽  
Amanda C Sremac ◽  
Patricia A Merriman ◽  
Craig J Della Valle ◽  
John W Burns ◽  
...  

IntroductionCognitive–behavioral therapy (CBT) can reduce preoperative pain catastrophizing and may improve postsurgical pain outcomes. We hypothesized that CBT would reduce pain catastrophizing more than no-CBT controls and result in improved pain outcomes.MethodsThe study was a randomized controlled trial of patients undergoing elective total knee arthroplasty between January 2013 and March 2020. In phase 1, the change in pain catastrophizing scores (PCS) among 4-week or 8-week telehealth, 4-week in person and no-CBT sessions was compared in 80 patients with a PCS >16. In phase 2, the proportion of subjects that achieved a 3-month decrease in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain subscale >4 following 4-week telehealth CBT with no-CBT controls were compared in 80 subjects.ResultsIn phase 1, 4-week telehealth CBT had the highest completion rate 17/20 (85%), demonstrated an adjusted median reduction in PCS of −9 (95% CI −1 to −14, p<0.01) compared with no-CBT and was non-inferior to 8-week telehealth CBT at a margin of 2 (p=0.02). In phase 2, 29 of 35 (83%) in the 4-week telehealth CBT and 26 of 33 (79%) subjects in the no-CBT demonstrated a decrease in the WOMAC pain subscale >4 at 3 months, difference 4% (95% CI −18% to 26%, p=0.48), despite a median decrease in the PCS for the 4-week CBT and no-CBT group of −6 (−10 to −2, p=0.02).ConclusionsOur findings demonstrate that CBT interventions delivered prior to surgery in person or via telehealth can reduced PCS scores; however, this reduction did not lead to improved 3-month pain outcomes.Trial registration numberClinicalTrials.gov (NCT 01772329, registration date 21 January 2013).


Author(s):  
Ryan A Mace ◽  
Melissa V Gates ◽  
Paula J Popok ◽  
Ron Kulich ◽  
Yakeel T Quiroz ◽  
...  

Abstract Background and Objectives The relationship between chronic pain (CP) and cognitive decline (CD) is bidirectional among older adults. The CP–CD comorbidity can progressively worsen cognitive, physical, emotional, and social functioning with aging. We explored the feasibility and outcomes associated with 2 mind–body activity programs for CP and CD that focus on increasing walking using time goals (Active Brains) or step-count reinforced via Fitbit (Active Brains–Fitbit). Research Design and Methods Older adults with CP and CD participated in a nonrandomized open pilot of Active Brains (n = 6) and Active Brains–Fitbit (n = 6) followed by exit interviews. Quantitative analysis explored feasibility markers and signals of improvement on physical, cognitive, and emotional function, as well as additional program targets. Qualitative analyses were predominantly deductive and applied the Framework Method to enhance the programs and methodology. Results Both programs met a priori feasibility benchmarks. We found within-group improvements for pain intensity, pain-specific coping, physical function, and cognitive function in both programs. Exit interviews confirmed high satisfaction with both programs. Discussion and Implications Our mixed-methods data provide preliminary evidence of feasibility, showed promise for improving outcomes, and yielded critical information to further enhance the programs. We discuss “lessons learned” and future directions.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jéssica Garcia Jorge ◽  
Ana Luiza Costa e Silva Cabral ◽  
Vanessa Martins Pereira Silva Moreira ◽  
Wallisen Tadashi Hattori ◽  
Valdeci Carlos Dionisio

Abstract Background The effect of hyperalgesia on functionality remains uncertain for individuals with knee osteoarthritis (KOA). This study aimed examine the clinical measures and hyperalgesia’s effect on muscle activity, knee range of motion (ROM) and postural control during the single-leg mini squat (SLMS) in individuals with KOA, determining the correlation between variables. Methods In this cross-sectional study, 60 individuals, 30 healthy (HG, 57.4 ± 6.86 years), and 30 with mild to moderate KOA (KOAG, 59.4 ± 5.46 years) were evaluated by the visual analog scale (VAS), Western Ontario and McMaster Universities Index (WOMAC), and the pressure pain threshold (PPT) in subcutaneous, myotomal, and sclerotomal structures. Muscle activity, knee ROM and postural control were assessed during a SLMS. The analyses were performed in the two phases of the SLMS. Phase 1 - during descending movement (eccentric contraction), Phase 2 - during ascending movement (concentric contraction). Analysis of covariance was applied for each variable separately, using weight as a co-variable. We used Spearman’s test for determining the correlation. Results There was no difference between groups for age, height, and postural control (p > 0.059), but KOAG presented the highest values for VAS and WOMAC (p = 0.000). In addition, EMG activity was higher in KOAG for gastrocnemius medialis and tibialis anterior muscles during phase 1 (p < 0.027), and for gastrocnemius medialis and gluteus medius muscles during phase 2 (p < 0.007), and reduced values for PPT and knee ROM (p = 0.000). Also, the correlations between PPT with muscle activity and postural control were moderate (rho< 0.482), while strong relationships were observed between some PPT points with VAS and WOMAC (rho> 0.507). Conclusion Hyperalgesia affects the functionality during a single-limb mini squat. There is an important correlation between hyperalgesia and muscle activity, postural control, and clinical measures in individuals with KOA.


2001 ◽  
Vol 60 (4) ◽  
pp. 215-230 ◽  
Author(s):  
Jean-Léon Beauvois

After having been told they were free to accept or refuse, pupils aged 6–7 and 10–11 (tested individually) were led to agree to taste a soup that looked disgusting (phase 1: initial counter-motivational obligation). Before tasting the soup, they had to state what they thought about it. A week later, they were asked whether they wanted to try out some new needles that had supposedly been invented to make vaccinations less painful. Agreement or refusal to try was noted, along with the size of the needle chosen in case of agreement (phase 2: act generalization). The main findings included (1) a strong dissonance reduction effect in phase 1, especially for the younger children (rationalization), (2) a generalization effect in phase 2 (foot-in-the-door effect), and (3) a facilitatory effect on generalization of internal causal explanations about the initial agreement. The results are discussed in relation to the distinction between rationalization and internalization.


2013 ◽  
Vol 5 (1) ◽  
Author(s):  
Abdul Hasan Saragih

This classroom research was conducted on the autocad instructions to the first grade of mechinary class of SMK Negeri 1 Stabat aiming at : (1) improving the student’ archievementon autocad instructional to the student of mechinary architecture class of SMK Negeri 1 Stabat, (2) applying Quantum Learning Model to the students of mechinary class of SMK Negeri 1 Stabat, arising the positive response to autocad subject by applying Quantum Learning Model of the students of mechinary class of SMK Negeri 1 Stabat. The result shows that (1) by applying quantum learning model, the students’ achievement improves significantly. The improvement ofthe achievement of the 34 students is very satisfactory; on the first phase, 27 students passed (70.59%), 10 students failed (29.41%). On the second phase 27 students (79.41%) passed and 7 students (20.59%) failed. On the third phase 30 students (88.24%) passed and 4 students (11.76%) failed. The application of quantum learning model in SMK Negeri 1 Stabat proved satisfying. This was visible from the activeness of the students from phase 1 to 3. The activeness average of the students was 74.31% on phase 1,81.35% on phase 2, and 83.63% on phase 3. (3) The application of the quantum learning model on teaching autocad was very positively welcome by the students of mechinary class of SMK Negeri 1 Stabat. On phase 1 the improvement was 81.53% . It improved to 86.15% on phase 3. Therefore, The improvement ofstudent’ response can be categorized good.


2020 ◽  
Vol 70 (suppl 1) ◽  
pp. bjgp20X711425
Author(s):  
Joanna Lawrence ◽  
Petronelle Eastwick-Field ◽  
Anne Maloney ◽  
Helen Higham

BackgroundGP practices have limited access to medical emergency training and basic life support is often taught out of context as a skills-based event.AimTo develop and evaluate a whole team integrated simulation-based education, to enhance learning, change behaviours and provide safer care.MethodPhase 1: 10 practices piloted a 3-hour programme delivering 40 minutes BLS and AED skills and 2-hour deteriorating patient simulation. Three scenarios where developed: adult chest pain, child anaphylaxis and baby bronchiolitis. An adult simulation patient and relative were used and a child and baby manikin. Two facilitators trained in coaching and debriefing used the 3D debriefing model. Phase 2: 12 new practices undertook identical training derived from Phase 1, with pre- and post-course questionnaires. Teams were scored on: team working, communication, early recognition and systematic approach. The team developed action plans derived from their learning to inform future response. Ten of the 12 practices from Phase 2 received an emergency drill within 6 months of the original session. Three to four members of the whole team integrated training, attended the drill, but were unaware of the nature of the scenario before. Scoring was repeated and action plans were revisited to determine behaviour changes.ResultsEvery emergency drill demonstrated improved scoring in skills and behaviour.ConclusionA combination of: in situ GP simulation, appropriately qualified facilitators in simulation and debriefing, and action plans developed by the whole team suggests safer care for patients experiencing a medical emergency.


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