scholarly journals 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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jéssica Bianca Aily ◽  
Aline Castilho de Almeida ◽  
Marcos de Noronha ◽  
Stela Marcia Mattiello
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
World Health ◽  
Circuit Training ◽  
Face To Face ◽  
Knee Oa ◽  
Randomized Controlled ◽  
End Point ◽  
Training Protocol

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.

scholarly journals A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms

2019 ◽  
Vol 32 (11) ◽  
pp. 1143-1154 ◽  
Author(s):  
Jack Farr ◽  
Andreas H. Gomoll ◽  
Adam B. Yanke ◽  
Eric J. Strauss ◽  
Katie C. Mowry ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Saline Control ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Symptomatic Knee ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported

AbstractPlacental-derived tissues are a known source of anti-inflammatory and immune modulating factors. Published pilot data on amniotic suspension allograft (ASA) for the treatment of osteoarthritis (OA) demonstrated safety and trends for improved pain and function. A multicenter randomized controlled trial was designed to evaluate the efficacy of symptom modulation with ASA compared with saline and hyaluronic acid (HA) in subjects with knee OA. A total of 200 subjects were randomized 1:1:1 to ASA, HA, or saline, with subjects blinded to their allocation. Changes from baseline of patient-reported outcomes (PROs)—EQ-5D-5L, Knee Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS), Tegner, and Single Assessment Numerical Evaluation (SANE)—were compared between groups. Patients reporting unacceptable pain at 3 months were considered treatment failures and withdrawn from the study. Statistical analysis was completed by comparing changes in PROs from baseline to 3 and 6 months for all groups. Comparison of demographics between treatment groups showed no significant differences between groups. Patients reporting unacceptable pain at 3 months in each group were ASA (13.2%), HA (68.8%), and saline (75%). Patients receiving ASA demonstrated significantly greater improvements from baseline for overall pain (VAS), KOOS pain, and KOOS-activities of daily living scores compared with those in the HA group (3 months) and both groups (6 months). ASA patients had significantly greater improvements in KOOS symptom scores compared with HA and saline at 3 and 6 months, respectively. OMERACT-OARSI responder rates for ASA, HA, and saline groups were 69.1, 39.1, and 42.6%, respectively (p = 0.0007). Subjects receiving ASA treatment showed greater improvements in PROs and fewer patients reported unacceptable pain compared with HA and saline. The evidence presented in this Level I Randomized Controlled Trial suggests that ASA injection is an effective treatment for the nonoperative management of symptomatic knee OA.

scholarly journals Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Linda C Li ◽  
Lynne M Feehan ◽  
Hui Xie ◽  
Na Lu ◽  
Christopher D Shaw ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Mean Difference ◽  
Knee Oa ◽  
Counseling Intervention ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Secondary Outcomes

BACKGROUND Current guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control. OBJECTIVE This study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA. METHODS This was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index. RESULTS We enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes. CONCLUSIONS A 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA. CLINICALTRIAL ClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323

scholarly journals Effects of variable frequencies of kinesthesia, balance and agility exercise program in adults with knee osteoarthritis: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Aysha I. Adhama ◽  
Mukadas O. Akindele ◽  
Aminu A. Ibrahim
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Knee Osteoarthritis ◽  
Conventional Therapy ◽  
Controlled Trial ◽  
Hip Osteoarthritis ◽  
Life Questionnaire ◽  
Knee Oa ◽  
Randomized Controlled

Abstract Background: Knee osteoarthritis (OA) is a common painful and disabling condition that affects older individuals. Proprioceptive training programs in the form of kinesthesia, balance and agility (KBA) exercises have been reported to be beneficial for individuals with knee OA. However, the most optimal treatment dosage of KBA exercise is still unclear. The aim of this study is to determine the effects of different frequencies of KBA treatment (i.e. twice-weekly or thrice-weekly) in adults with knee OA.Methods: A single (assessor) blind, three-arm parallel, multi-center randomized controlled trial will be conducted. Eighty-four adults with knee OA will be recruited from four tertiary hospitals in Northwestern Nigeria and randomly assigned into one of three intervention groups; twice-weekly KBA (n = 28), thrice-weekly KBA (n = 28), and conventional physiotherapy or control (n = 28) in the ratio of 1:1:1. Participants in the conventional therapy group will receive two sessions of brief patient education, and 16 sessions of ultrasound therapy, stretching and strengthening exercises for 8 weeks. Participants in the two different KBA groups will receive KBA exercise according to the designed sessions for 8 weeks in addition to the conventional therapy. All groups will be assessed pre-intervention, immediately post-intervention and at 8 weeks, 3-month, 4-month, and 6-month post-randomization. The primary outcome will be physical function (Ibadan Knee and Hip Osteoarthritis Outcome Measure) while the secondary outcomes will be pain (Visual Analogue Scale for pain), knee stability (Knee Outcome Survey-Activities of Daily Living Scale), proprioception (electronic goniometer), and quality of life (Osteoarthritis Knee and Hip Quality of Life Questionnaire).Discussion: Findings of this study may provide evidence on the effectiveness of KBA exercise and the ideal number of sessions needed to achieve the highest effectiveness in adults with knee OA.Trial registration: Pan African Clinical Trials Registry, (PACTR201810713260138), Retrospectively registered on 28 November 2017.

The Effect of Mobile Instant Messaging versus Face-to-Face Counseling on the Primiparous Mothers’ Breastfeeding Self-efficacy: A Pilot Randomized Controlled Trial

2020 ◽  
Author(s):  
Manoosh Mehrabi ◽  
Shoale Zarei ◽  
Leila Bazrafkan ◽  
Ali Reza Safarpour
Keyword(s):  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Instant Messaging ◽  
Controlled Trial ◽  
World Health ◽  
Face To Face ◽  
Randomized Controlled ◽  
The World ◽  
The Impact ◽  
Pilot Randomized Controlled Trial

Abstract Background Increasing breastfeeding rates around the world is one of the most important goals of the World Health Organization. Self-efficacy is a modifying and predictive factor for initiation and continuation of breastfeeding. This study was conducted to investigate the impact of mobile-based education and regular delivery of designed messages on breastfeeding self-efficacy in primiparous mothers. Methods This study was a double blind pilot randomized controlled trial, in which a hundred and twenty primiparous breastfeeding mothers were randomly allocated into two groups using permuted block randomization. The standard method conseling arm received routine counseling interventions and the intervention arm received a mobile instant messaging program in addition to the usual counseling. The main objective of this study was to compare self-efficacy in face-to-face counseling group and mobile instant messaging group. Self-efficacy levels were compared in the two groups before and after the study procedures. Results In this study, 60 mothers were studied in each group, and then the collected data were analyzed. The mean post-test scores in the intervention group (60.40 ± 4.92) and the control group (50.10 ± 7.60) were compared in the main analysis. The results indicated a statistically significant difference (p <0.001). Given the amount of effect size ( d= 0.99; 95% CI=1.19-2.02 ) it appears that there is a high level correlation between the applied intervention and level of self-efficacy among the study participants, especially those with higher levels of education. Secondary findings of the study involved evaluating the effects of education, occupation, family income, lactation duration and spouse support for breastfeeding self-efficacy. Except for the maternal education level, which had a significant relationship with the level of breastfeeding self-efficacy (p= 0.02), the other factors did not show any correlation with self-efficacy in breastfeeding. Conclusion The pilot study provided valuable information for feasibility assessment of randomized controlled trials in future studies with larger sample sizes and more participant diversity.

scholarly journals Preparing for an orthopedic consultation using an eHealth tool: a randomized controlled trial in patients with hip and knee osteoarthritis

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Aniek A. O. M. Claassen ◽  
Henk J. Schers ◽  
Vincent J. J. F. Busch ◽  
Petra J. C. Heesterbeek ◽  
Frank H. J. van den Hoogen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Satisfaction ◽  
Knee Osteoarthritis ◽  
Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Information Provision ◽  
Treatment Beliefs ◽  
Knee Oa ◽  
Randomized Controlled

Abstract Background To evaluate the effect of a stand-alone mobile and web-based educational intervention (eHealth tool) compared to usual preparation of a first orthopedic consultation of patients with hip or knee osteoarthritis (OA) on patients’ satisfaction. Methods A two-armed randomized controlled trial involving 286 patients with (suspicion of) hip or knee OA, randomly allocated to either receiving an educational eHealth tool to prepare their upcoming consultation (n = 144) or usual care (n = 142). Satisfaction with the consultation on three subscales (range 1–4) of the Consumer Quality Index (CQI - primary outcome) and knowledge (assessed using 22 statements on OA, range 0–22), treatment beliefs (assessed by the Treatment beliefs in OsteoArthritis questionnaire, range 1–5), assessment of patient’s involvement in consultation by the surgeon (assessed on a 5-point Likert scale) and patient satisfaction with the outcome of the consultation (numeric rating scale), were assessed. Results No differences between groups were observed on the 3 subscales of the CQI (group difference (95% CI): communication 0.009 (− 0.10, 0.12), conduct − 0.02 (− 0.12, 0.07) and information provision 0.02 (− 0.18, 0.21)). Between group differences (95% CI) were in favor of the intervention group for knowledge (1.4 (0.6, 2.2)), negative beliefs regarding physical activities (− 0.19 (− 0.37, − 0.002) and pain medication (− 0.30 (− 0.49, − 0.01)). We found no differences on other secondary outcomes. Conclusions An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis. Trial registration Dutch Trial Register (trial number NTR6262). Registered 30 January 2017.

scholarly journals Effects of Neuromuscular Electrical Stimulation Combined with Exercises versus an Exercise Program on the Pain and the Function in Patients with Knee Osteoarthritis: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Aline Mizusaki Imoto ◽  
Stella Peccin ◽  
Kelson Nonato Gomes da Silva ◽  
Lucas Emmanuel Pedro de Paiva Teixeira ◽  
Marcelo Ismael Abrahão ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Electrical Stimulation ◽  
Knee Osteoarthritis ◽  
Rating Scale ◽  
Controlled Trial ◽  
Neuromuscular Electrical Stimulation ◽  
Functional Improvement ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Significant Difference

Objectives. To investigate the effect of 8 weeks of NMES + Ex (neuromuscular electrical stimulation combined with exercises) on pain and functional improvement in patients with knee osteoarthritis (OA) compared to exercise (Ex) alone.Design. Randomized controlled trial.Setting. A specialty outpatient clinic.Participants. Patients (N=100; women = 86, men = 14; age range, 50–75 years) with knee OA.Interventions. Participants were randomly assigned to NMES + Ex or Ex group.Outcome Measures. Numerical Rating Scale 0 to 10 (NRS) and the Timed Up and Go (TUG) test were the primary outcomes. The secondary outcomes used were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).Results. Following the interventions, a statistically significant improvement in both groups was observed in all outcomes assessed. For the comparison between the groups, no statistically significant difference was found between the NMES + Ex and the Ex groups in NRS (P=0.52), TUG test (P=0.12), and aspects of WOMAC: pain (P=0.26), function (P=0.23), and stiffness (P=0.63).Conclusion. The addition of NMES to exercise did not improve the outcomes assessed in knee OA patients. This study was registered at the Australian Clinical Trials Registry (ACTRN012607000357459).

scholarly journals Aquatic Physical Therapy for Hip and Knee Osteoarthritis: Results of a Single-Blind Randomized Controlled Trial

2007 ◽  
Vol 87 (1) ◽  
pp. 32-43 ◽  
Author(s):  
Rana S Hinman ◽  
Sophie E Heywood ◽  
Anthony R Day
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Physical Therapy ◽  
Muscle Strength ◽  
Knee Osteoarthritis ◽  
Physical Function ◽  
Controlled Trial ◽  
Knee Oa ◽  
Randomized Controlled

Background and Purpose Aquatic physical therapy is frequently used in the management of patients with hip and knee osteoarthritis (OA), yet there is little research establishing its efficacy for this population. The purpose of this study was to evaluate the effects of aquatic physical therapy on hip or knee OA. Subjects A total of 71 volunteers with symptomatic hip OA or knee OA participated in this study. Methods The study was designed as a randomized controlled trial in which participants randomly received 6 weeks of aquatic physical therapy or no aquatic physical therapy. Outcome measures included pain, physical function, physical activity levels, quality of life, and muscle strength. Results The intervention resulted in less pain and joint stiffness and greater physical function, quality of life, and hip muscle strength. Totals of 72% and 75% of participants reported improvements in pain and function, respectively, compared with only 17% (each) of control participants. Benefits were maintained 6 weeks after the completion of physical therapy, with 84% of participants continuing independently. Discussion and Conclusion Compared with no intervention, a 6-week program of aquatic physical therapy resulted in significantly less pain and improved physical function, strength, and quality of life. It is unclear whether the benefits were attributable to intervention effects or a placebo response.

scholarly journals Using technology to scale-up training and supervision of community health workers in the psychosocial management of perinatal depression: a non-inferiority, randomized controlled trial

2019 ◽  
Vol 6 ◽  
Author(s):  
Atif Rahman ◽  
Parveen Akhtar ◽  
Syed Usman Hamdani ◽  
Najia Atif ◽  
Huma Nazir ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Community Health Workers ◽  
Health Workers ◽  
Controlled Trial ◽  
Scale Up ◽  
World Health ◽  
Face To Face ◽  
Randomized Controlled ◽  
Training And Supervision

Background.The Thinking Healthy Programme (THP) is an evidence-based psychological intervention endorsed by the World Health Organization, tailored for non-specialist health workers in low- and middle-income countries. However, training and supervision of large numbers of health workers is a major challenge for the scale-up of THP. We developed a ‘Technology-Assisted Cascaded Training and Supervision system’ (TACTS) for THP consisting of a training application and cascaded supervision delivered from a distance.Methods.A single-blind, non-inferiority, randomized controlled trial was conducted in District Swat, a post-conflict area of North Pakistan. Eighty community health workers (called Lady Health Workers or LHWs) were randomly assigned to either TACTS or conventional face-to-face training and supervision by a specialist. Competence of LHWs in delivering THP post-training was assessed by independent observers rating a therapeutic session using a standardized measure, the ‘Enhancing Assessment of Common Therapeutic factors’ (ENACT), immediately post-training and after 3 months. ENACT uses a Likert scale to score an observed interaction on 18 dimensions, with a total score of 54, and a higher score indicating greater competence.Results.Results indicated no significant differences between health workers trained using TACTS and supervised from distancev.those trained and supervised by a specialist face-to-face (mean ENACT score M  =  24.97,s.d.  =  5.95v.M =  27.27,s.d.  =  5.60,p  =  0.079, 95% CI 4.87–0.27) and at 3 months follow-up assessment (M  =  44.48,s.d.  =  3.97v.M =  43.63,s.d.  =  6.34,p  =  0.53, CI −1.88 to 3.59).Conclusions.TACTS can provide a promising tool for training and supervision of front-line workers in areas where there is a shortage of specialist trainers and supervisors.

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