Dataset Information

Effects of a periodized circuit training protocol delivered by telerehabilitation compared to face-to-face method for knee osteoarthritis: a protocol for a non-inferiority randomized controlled trial.

ABSTRACT:

Background

Regular exercise is an effective method for reducing pain and disability in patients with knee osteoarthritis (OA), as well as improving body composition. Thus, a combination of both resistance and aerobic training (circuit training) has shown to be promising for this population. However, access to physical therapy is limited by physical distance, social isolation, and/or treatment costs. Remote rehabilitation seems to be an effective way to minimize these barriers, but the benefits are dependent on the participants' adherence to the interventions provided at a distance. The objectives of this protocol are to compare the effects of a periodized circuit training applied via telerehabilitation with the same protocol applied in the face-to-face model for individuals with knee OA.

Methods

This study presents a single-blinded protocol for a non-inferiority randomized controlled trial. One hundred participants diagnosed with knee OA (grades II and III Kellgren and Lawrence system), aged 40 years or more, and BMI < 30 kg/m² will be randomly divided into two groups: telerehabilitation (TR) and face-to-face (FtF) circuit training. The FtF group will perform a 14-week periodized circuit training protocol supervised by a physical therapist, 3 times a week. The TR group will perform the same exercise protocol at home, at least 3 times a week. In addition, the TR group will be able to follow the execution and orientations of the exercises by DVD, a website, and online file sharing tools, and they will receive periodic phone calls in order to motivate, clarify, and inform some aspects of knee OA. The primary outcomes are changes in self-reported pain intensity (visual analog scale (VAS)) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)), with a primary end-point of 14 weeks and a secondary end-point of 26 weeks. Secondary outcomes include changes in other clinical outcomes, in morphological characteristics, adherence, acceptability, and treatment perspective.

Discussion

A circuit training through telerehabilitation may contribute to developing early intervention in the causative and potentiating factors of the knee OA, verifying the effects of a low-cost, non-pharmacological and non-invasive treatment.

Trial registration

Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-662hn2. Registered on 31 March 2019. Link: http://www.ensaiosclinicos.gov.br ; Universal Trial Number (UTN) of World Health Organization: U1111-1230-9517.

SUBMITTER: Aily JB

PROVIDER: S-EPMC8646353 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundThe objective of this study is to analyze the influence of a 14-week periodized circuit training protocol on patients with knee osteoarthritis (OA), in randomized intervention groups, on thigh intermuscular adipose tissue (interMAT), body composition, systemic inflammation, cartilage degradation, and its repercussion on pain, functional performance and quality of life.MethodsThis study presents a protocol for a randomized controlled trial. Sixty selected participants diagnosed with knee OA grades II and III, 40-65 years old and BMI < 30 kg/m2, will be randomly divided into three groups:periodized circuit training, strength training, and educational protocol. The circuit training and strength training protocols consist of 14-week training protocols conducted 3 times a week. The circuit training group will perform selected exercises previously stratified as light, moderate, and intense, arranged progressively in a circuit model, the strength group will perform regular strength exercises, and the educational protocol group will participate in a 14-week protocol with lectures twice a month about healthy lifestyles. Baseline and follow-up evaluations will be conducted for thigh interMAT (computed tomography), body composition (DXA), inflammation (IL-1β, IL-6, IL-10, TNF-α, leptin, and adiponectin), and joint degradation biomarkers (uCTX-II and sCOMP), performance-based tests (30s Chair Stand Test, 40 m Fast-paced Walk Test and Stair Climb Test), quadriceps and hamstring maximal isometric voluntary contraction (MIVC), and questionnaires (WOMAC and pain catastrophizing scale). Repeated measures ANOVA will be used to compare differences between groups (circuit training X strength training X educational protocol) at the different times of assessment (baseline x follow-up or baseline x during protocol x follow-up) for each of the dependent variables. When significant main effects were found, the pots hoc Bonferroni test will be used to identify statistical differences. A significance level of 5% (p < 0.05) will be adopted.DiscussionThis will be the first randomized controlled trial to assess the effects of a circuit training protocol on patients with knee OA on thigh intermuscular adipose tissue (interMAT). Given the prevalence and impact of OA and the widespread availability of this intervention, assessing the efficacy of a low-cost, non-pharmacological, and non-invasive treatment for knee OA patients has the potential for immediate and high clinical impact.Trial registrationClinicalTrials.gov, NCT02761590 , registered in May 4, 2016.

Project description:IntroductionPulsed electromagnetic field (PEMF) is an available treatment for knee osteoarthritis (KOA), which is the most common cause of pain and disability. Nonetheless, whether the clinical effects are like that of most used drugs is unclear. Thus, this study aims to determine the effect of PEMF on pain relief by comparing them with the positive drug (celecoxib). Furthermore, this clinical trial aims to evaluate the effect of PEMF on function and quality of life with a long-term follow-up.Methods and analysisThis two-armed, non-inferiority, randomised, controlled trial will be conducted in the outpatient physiatry/physiotherapy clinic or inpatient ward of 17 hospitals in China. A total of 428 individuals will be included who are more than 40 years of age with diagnosed KOA. The participants will be randomly allocated to the PEMF group: receiving a 6-week PEMF (15 Hz, 30 mT) at a frequency of 40 min per day, 5 days per week plus sham drug (n=214), or drug group: receiving a 6-week celecoxib 200 mg combined with sham PEMF (n=214). Clinical outcomes will be measured at baseline (T0), mid-term of intervention (T1), post-intervention (T2), 10, 18 and 30 weeks (T3-5) of follow-up after randomisation. The primary outcome will be the Western Ontario and McMaster Universities (WOMAC) pain index. The secondary outcomes will be WOMAC function and stiffness, pain measured by numerical rating score, quality of life, 6-minute walk test, pain catastrophising scale and responder index.Ethics and disseminationThe trial is performed following the Declaration of Helsinki. The study protocol and consent form have been approved by the Ethics Committee on Biomedical Research of West China Hospital of Sichuan University (#2021-220). All patients will give informed consent before participation and the trial is initiated after approval. Results of this trial will be disseminated through publication in peer-reviewed journals.Trial registration numberChiCTR2100052131.

Project description:ImportanceDigital care platforms have been introduced, but there is limited evidence for their efficacy compared with traditional face-to-face treatment modalities.ObjectiveTo compare mean pain reduction among individuals with osteoarthritis (OA) of the knee or hip who underwent face-to-face vs digital first-line intervention.Design, setting, and participantsThis registry-based cohort study included all persons with knee or hip osteoarthritis who participated in structured first-line treatment for osteoarthritis in a primary care setting in Sweden. Inclusion criteria were as follows: the treatment was delivered face-to-face or digitally between April 1, 2018, and December 31, 2019; patients provided 3-month follow-up data for pain; and patients had program adherence of at least 80%. Data analysis was conducted in March 2021.ExposuresParticipants completed a 3-month intervention, including education and exercise for hip or knee osteoarthritis, with program adherence of 80% or higher, delivered face-to-face or by a digital application.Main outcomes and measuresDifference in change in joint pain (11-point numeric rating scale, with 0 indicating no pain and 10, the worst possible pain) between baseline and 3-month follow-up between the 2 intervention modalities. A minimal clinically important difference in pain change between groups was predefined as 1 point. Secondary outcomes were walking difficulties, health-related quality of life, willingness to undergo joint surgery, and fear avoidance behavior.ResultsA total of 6946 participants (mean [SD] age, 67 [9] years; 4952 [71%] women; 4424 [64%] knee OA; 2504 [36%] hip OA) were included, with 4237 (61%) receiving face-to-face treatment and 2709 (39%) receiving digital treatment. Both the face-to-face (mean change, -1.10 [95% CI -1.17 to -1.02] points) and digital interventions (mean change, -1.87 [95% CI, -1.94 to -1.79] points) resulted in a clinically important pain reduction at 3 months. Participants in the digitally delivered intervention experienced a larger estimated improvement at 3 months (adjusted mean difference, -0.93 [95% CI, -1.04 to -0.81] points). Results of secondary outcomes were broadly consistent with main outcome.Conclusions and relevanceThis Swedish national registry-based cohort study showed that people with knee or hip OA participating in first-line intervention experienced clinically relevant improvements in pain, whether delivered face-to-face or digitally. The increased benefit of digital delivery compared with face-to-face delivery was of uncertain clinical importance.

Project description:BackgroundTo compare the efficacy and safety of bioavailable turmeric extract versus paracetamol in patients with knee osteoarthritis (OA).MethodsIn this randomized, non-inferiority, controlled clinical study, patients of knee OA were randomized to receive bioavailable turmeric extract (BCM-95®) 500?mg capsule two times daily or paracetamol 650?mg tablet three times daily for 6?weeks. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The secondary outcome measures were WOMAC total, WOMAC stiffness, and WOMAC physical function scores. Responder analysis of individual patients at different levels (??20%, ??50%, and???70%) for WOMAC score was calculated. TNF alpha and CRP levels were evaluated and adverse events (AE) were also recorded.ResultsSeventy-one and seventy-three knee OA patients, respectively in bioavailable turmeric extract and paracetamol groups, completed the study. Non-inferiority (equivalence) test showed that WOMAC scores were equivalent in both the groups (p value <?0.05) in all the domains within the equivalence limit defined by effect size (Cohen's d) of 0.5 whereas CRP and TNF-? were better reduced with turmeric extract than paracetamol. After 6?weeks of treatment, WOMAC total score, pain, stiffness, and function scores got a significant improvement of 23.59, 32.09, 28.5, and 20.25% respectively with turmeric extract. In the turmeric extract group, 18% of patients got more than 50% improvement and 3% of patients got more than 70% improvement in WOMAC pain and function/stiffness score and none of the patients in the paracetamol group met the criteria. CRP and TNF-? got significantly reduced (37.21 and 74.81% respectively) in the turmeric extract group. Adverse events reported were mild and comparatively less in the turmeric extract group (5.48%) than in the paracetamol group (12.68%).ConclusionThe results of the study suggest that bioavailable turmeric extract is as effective as paracetamol in reducing pain and other symptoms of knee osteoarthritis and found to be safe and more effective in reducing CRP and TNF-?.Trial registrationClinical Trials Registry - India CTRI/2017/02/007962 . Registered on 27 February 2017.

Project description:BackgroundThis prospective, multisite, blinded, randomized, non-inferiority clinical study aimed to confirm the efficacy and safety of enflicoxib in the treatment of pain and inflammation associated with canine osteoarthritis. A total of 180 dogs were randomized to receive enflicoxib (n = 78), mavacoxib (n = 80) or placebo (n = 22). Dogs underwent veterinary assessments from day 0 to day 42 using a clinical sum score (CSS). Efficacy was also assessed by the owners using the Canine Brief Pain Inventory (CBPI). The primary efficacy endpoint was the overall CSS from day 0 to day 42.ResultsThe overall CSS expressed as area under the curve demonstrated non-inferiority of enflicoxib compared to mavacoxib, and both showed superiority over placebo. At the end of the study, average CSS, and the percentage of CSS responders for enflicoxib (3.64 and 74%) and mavacoxib (4.49 and 68%), was superior to placebo (7.15 and 29%). A faster onset of action was observed for enflicoxib as superiority over placebo was evidenced from the first efficacy assessment (day 7) onwards for both parameters, whereas mavacoxib was only significantly different from day 14 onwards. According to the owner assessment, the percentage of CBPI responders was 90%, 79%, and 43% for dogs treated with enflicoxib, mavacoxib and placebo, respectively, and superiority over placebo was demonstrated for both active treatments. In all secondary parameters, non-inferiority of enflicoxib versus mavacoxib was confirmed. The dog's quality of life improved in all groups, but only enflicoxib showed superiority versus placebo. When assessing severely affected dogs only, results were similar, thus confirming the efficacy of enflicoxib in all stages of canine OA. There were no differences between groups in the frequency of adverse events, which were most frequently mild affecting the gastrointestinal tract and recovered without treatment.ConclusionsEnflicoxib is efficacious and safe for the treatment of pain and inflammation in any stage of canine osteoarthritis with a faster onset of action compared to mavacoxib.

Project description:To assess cost-effectiveness and cost utility of telerehabilitation (TR) versus standard rehabilitation (SR) after total knee replacement (TKR).Markov decision modelling of cost-effectiveness and cost-utility analysis based on patient-level and secondary data sources employing Italian National Health Service (NHS; Ita-NHS) and Society perspectives.Primary care units (PCUs) in Italy.Patients discharged after TKR.Mixed SR-TR service (10 face-to-face sessions and 10 telesessions) versus SR (20 face-to-face sessions)The incremental cost per additional knee flexion range of motion (ROM) and per QALY gained by SR-TR compared with SR. Second, we considered the probability of being cost-effective and the probability of being more effective and less expensive.TR appears to be the cost-effective in the base case and in all of the considered scenarios, but is no longer more effective and less expensive if transportation costs are excluded. Comparing SR-TR with SR, the incremental cost-effectiveness ratio (ICER) adopting the Ita-NHS perspective for the base case was -€117/ROM gained. The cost-effectiveness probability for SR-TR was 0.98 (ceiling ratio: €50/ROM), while the joint probability of being more effective and less expensive was 0.87. Assuming that TR would increase health-related quality of life (HRQOL) utilities by 2.5%, the ICER adopting Ita-NHS perspective is -€960/QALY (cost-effectiveness probability: 1; ceiling ratio: €30 000/QALY). All the performed sensitivity analyses did not change the conclusions, but if transportation costs were excluded, the probability for SR-TR of being more clinically effective and less expensive reduced to 0.56.The analysis suggested SR-TR to be cost-effective, even less expensive and more effective if the PCUs provide ambulance transportations. However, the uncertainty related to TR costs, HRQOL and long-term clinical outcomes raises important topics for future research, which should be addressed to confirm our estimates.ISRCTN45837371.