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Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one).

ABSTRACT: BACKGROUND:Osteoarthritis (OA) is not limited to joint pain and stiffness, which can lead to disability; it is also linked to comorbidities such as overweight, obesity and fears and beliefs related to the pathology. The knee OA population appears more affected by these risk factors and has a lower physical activity (PA) level than the general population. The key challenge for OA treatment is increasing the PA level to decrease the risk factors. METHODS:We aim to perform a prospective, multicentric, quasi-randomized controlled trial with an alternate-month design (1-month periods). People aged 50-75 years old with symptomatic knee OA (stage I-IV Kellgren and Lawrence scale) with low and moderate PA level will be included in 3 spa therapy resorts. The experimental arm will receive 5 self-management exercise sessions (1.5 h each; education, aerobics, strength training, range of motion)?+?an information booklet +?18 sessions (1 h each) of spa therapy treatment (STT). The active comparator arm will receive an information booklet +?18 sessions of STT. The primary outcome will be a change at 3 months in PA level (International Physical Activity Questionnaire short form score). Secondary outcomes will be function (WOMAC) pain (numerical scale), anxiety/depression (HAD), fears and beliefs about OA (KOFBeQ) and arthritis self-efficacy (ASES). The barriers to and facilitators of regular PA practice will be assessed by using specific items specifically designed for the study because of lack of any reference scale. DISCUSSION:The study could demonstrate the impact of a self-management exercise program associated with spa therapy in the medium term by increasing PA level in people with OA. A benefit for ameliorating fears and beliefs and anxiety/depression and improving self-efficacy will also be analysed. The findings could offer new prospects while establishing best clinical practice guidelines for this population. TRIAL REGISTRATION:ClinicalTrials.gov NCT02598804 (November 5, 2015).

SUBMITTER: Gay C

PROVIDER: S-EPMC6192279 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one).

Gay Chloe C Guiguet-Auclair Candy C Pereira Bruno B Goldstein Anna A Bareyre Loïc L Coste Nicolas N Coudeyre Emmanuel E

BMC complementary and alternative medicine 20181016 1

<h4>Background</h4>Osteoarthritis (OA) is not limited to joint pain and stiffness, which can lead to disability; it is also linked to comorbidities such as overweight, obesity and fears and beliefs related to the pathology. The knee OA population appears more affected by these risk factors and has a lower physical activity (PA) level than the general population. The key challenge for OA treatment is increasing the PA level to decrease the risk factors.<h4>Methods</h4>We aim to perform a prospect ...[more]

PMID: 30326906

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Project description:BackgroundEvidence-based models are needed to deliver exercise-related services for knee osteoarthritis efficiently and according to patient needs.ObjectiveTo examine a stepped exercise program for patients with knee osteoarthritis (STEP-KOA).DesignRandomized controlled trial. (ClinicalTrials.gov: NCT02653768).Setting2 U.S. Department of Veterans Affairs sites.Participants345 patients (mean age, 60 years; 15% female; 67% people of color) with symptomatic knee osteoarthritis.InterventionParticipants were randomly assigned in a 2:1 ratio to STEP-KOA or an arthritis education (AE) control group, respectively. The STEP-KOA intervention began with 3 months of an internet-based exercise program (step 1). Participants who did not meet response criteria for improvement in pain and function after step 1 progressed to step 2, which involved 3 months of biweekly physical activity coaching calls. Participants who did not meet response criteria after step 2 went on to in-person physical therapy visits (step 3). The AE group received educational materials via mail every 2 weeks.MeasurementsPrimary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scores for the STEP-KOA and AE groups at 9 months were compared by using linear mixed models.ResultsIn the STEP-KOA group, 65% of participants (150 of 230) progressed to step 2 and 35% (81 of 230) to step 3. The estimated baseline WOMAC score for the full sample was 47.5 (95% CI, 45.7 to 49.2). At 9-month follow-up, the estimated mean WOMAC score was 6.8 points (CI, -10.5 to -3.2 points) lower in the STEP-KOA than the AE group, indicating greater improvement.LimitationParticipants were mostly male veterans, and follow-up was limited.ConclusionVeterans in STEP-KOA reported modest improvements in knee osteoarthritis symptoms compared with the control group. The STEP-KOA strategy may be efficient for delivering exercise therapies for knee osteoarthritis.Primary funding sourceDepartment of Veterans Affairs, Health Services Research and Development Service.

Project description:Certain exercises could overload the osteoarthritic knee. We developed an exercise program from yoga postures with a minimal knee adduction moment for knee osteoarthritis. The purpose was to compare the effectiveness of this biomechanically-based yoga exercise (YE), with traditional exercise (TE), and a no-exercise attention-equivalent control (NE) for improving pain, self-reported physical function and mobility performance in women with knee osteoarthritis.Single-blind, three-arm randomized controlled trial.Community in Southwestern Ontario, Canada.A convenience sample of 31 women with symptomatic knee osteoarthritis was recruited through rheumatology, orthopaedic and physiotherapy clinics, newspapers and word-of-mouth.Participants were stratified by disease severity and randomly allocated to one of three 12-week, supervised interventions. YE included biomechanically-based yoga exercises; TE included traditional leg strengthening on machines; and NE included meditation with no exercise. Participants were asked to attend three 1-hour group classes/sessions each week.Primary outcomes were pain, self-reported physical function and mobility performance. Secondary outcomes were knee strength, depression, and health-related quality of life. All were assessed by a blinded assessor at baseline and immediately following the intervention.The YE group demonstrated greater improvements in KOOS pain (mean difference of 22.9 [95% CI, 6.9 to 38.8; p = 0.003]), intermittent pain (mean difference of -19.6 [95% CI, -34.8 to -4.4; p = 0.009]) and self-reported physical function (mean difference of 17.2 [95% CI, 5.2 to 29.2; p = 0.003]) compared to NE. Improvements in these outcomes were similar between YE and TE. However, TE demonstrated a greater improvement in knee flexor strength compared to YE (mean difference of 0.1 [95% CI, 0.1 to 0.2]. Improvements from baseline to follow-up were present in quality of life score for YE and knee flexor strength for TE, while both also demonstrated improvements in mobility. No improvement in any outcome was present in NE.The biomechanically-based yoga exercise program produced clinically meaningful improvements in pain, self-reported physical function and mobility in women with clinical knee OA compared to no exercise. While not statistically significant, improvements in these outcomes were larger than those elicited from the traditional exercise-based program. Though this may suggest that the yoga program may be more efficacious for knee OA, future research studying a larger sample is required.ClinicalTrials.gov (NCT02370667).

Project description:BackgroundKnee osteoarthritis (KOA) is common in elderly people, causes pain, loss of physical functioning, and disability. This was a two-arm, superiority, quasi-experimental trial. The aim of this study was to evaluate the effectiveness of a home-based exercise intervention (HBEI) to reduce KOA symptoms and improve the physical functioning of elderly patients.MethodsA total of 171 elderly patients (60 years of age or older) with KOA were recruited from four community centers. Patients from two community centers were randomly assigned to the intervention group (IG) and the other two centers were randomly assigned to the control group (CG). Participants in the IG received a 12-week HBEI (including four 2-h sessions supervised by a physiotherapist and fortnightly telephone support) combined with health education, while patients in the CG only received health education. The participants and physiotherapists were aware of the group assignment and alternative treatment components, but the study's hypotheses were not disclosed to the participants. Pain intensity, joint stiffness, lower-limb muscle strength, balance, mobility, and quality of life were measured before and after the intervention by the same blinded assessor.ResultsA total of 171 patients (IG: n = 84, CG: n = 87) were enrolled. Data were obtained from 141 patients with an average age of 68 (range, 60-86 years) who completed the 12-week study (IG: n = 71, CG: n = 70). No significant group differences were found in any outcome measures at baseline. At week 12, the pretest/posttest changes 3significant between-group differences in decreases in pain intensity (- 1.60 (CI, - 2.75 to - 0.58)) and stiffness (- 0.79 (CI, - 1.37 to - 0.21)), with the IG exhibiting significantly larger improvements on both measures than the CG. The IG also showed significantly greater improvements on all the secondary outcomes than the CG did.ConclusionsHBEI may be effective for relieving KOA symptoms, increasing the physical functioning, and improving quality of life in community-dwelling KOA elderly patients. A large randomized controlled trial with long-term follow-up is needed to confirm these findings.Trial registrationChinese Clinical Trails Registry number ChiCTR1800017026 (retrospectively registered). Registered 9 July 2018.

Project description:BackgroundPhysical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions.Methods / designStep-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA.DiscussionSTEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA.Trial registrationClinicaltrials.gov, NCT02653768 (STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)), Registered January 12, 2016.

Dataset Information

Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one).

Publications

Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one).

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