Effects of Diet Control and Telemedicine-Based Resistance Exercise Intervention on Patients with Obesity and Knee Osteoarthritis: A Randomized Control Trial.
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SUBMITTER: Hsu YI
PROVIDER: S-EPMC8345675 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ImportanceSome weight loss and exercise programs that have been successful in academic center-based trials have not been evaluated in community settings.ObjectiveTo determine whether adaptation of a diet and exercise intervention to community settings resulted in a statistically significant reduction in pain, compared with an attention control group, at 18-month follow-up.Design, setting, and participantsAssessor-blinded randomized clinical trial conducted in community settings in urban and rural counties in North Carolina. Patients were men and women aged 50 years or older with knee osteoarthritis and overweight or obesity (body mass index ≥27). Enrollment (N = 823) occurred between May 2016 and August 2019, with follow-up ending in April 2021.InterventionsPatients were randomly assigned to either a diet and exercise intervention (n = 414) or an attention control (n = 409) group for 18 months.Main outcomes and measuresThe primary outcome was the between-group difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain score (range, 0 [none] to 20 [severe]; minimum clinically important difference, 1.6) over 18 months, tested using a repeated-measures mixed linear model with adjustments for covariates. There were 7 secondary outcomes including body weight.ResultsAmong the 823 randomized patients (mean age, 64.6 years; 637 [77%] women), 658 (80%) completed the trial. At 18-month follow-up, the adjusted mean WOMAC pain score was 5.0 in the diet and exercise group (n = 329) compared with 5.5 in the attention control group (n = 316) (adjusted difference, -0.6; 95% CI, -1.0 to -0.1; P = .02). Of 7 secondary outcomes, 5 were significantly better in the intervention group compared with control. The mean change in unadjusted 18-month body weight for patients with available data was -7.7 kg (8%) in the diet and exercise group (n = 289) and -1.7 kg (2%) in the attention control group (n = 273) (mean difference, -6.0 kg; 95% CI, -7.3 kg to -4.7 kg). There were 169 serious adverse events; none were definitely related to the study. There were 729 adverse events; 32 (4%) were definitely related to the study, including 10 body injuries (9 in diet and exercise; 1 in attention control), 7 muscle strains (6 in diet and exercise; 1 in attention control), and 6 trip/fall events (all 6 in diet and exercise).Conclusions and relevanceAmong patients with knee osteoarthritis and overweight or obesity, diet and exercise compared with an attention control led to a statistically significant but small difference in knee pain over 18 months. The magnitude of the difference in pain between groups is of uncertain clinical importance.Trial registrationClinicalTrials.gov Identifier: NCT02577549.
| S-EPMC9856237 | biostudies-literature
Project description:BackgroundOsteoarthritis (OA), the leading cause of disability among adults, has no cure and is associated with significant comorbidities. The premise of this randomized clinical trial is that, in a population at risk, a 48-month program of dietary weight loss and exercise will result in less incident structural knee OA compared to control.Methods/designThe Osteoarthritis Prevention Study (TOPS) is a Phase III, assessor-blinded, 48-month, parallel 2 arm, multicenter randomized clinical trial designed to reduce the incidence of structural knee OA. The study objective is to assess the effects of a dietary weight loss, exercise, and weight-loss maintenance program in preventing the development of structural knee OA in females at risk for the disease. TOPS will recruit 1230 ambulatory, community dwelling females with obesity (Body Mass Index (BMI) ≥ 30 kg/m2) and aged ≥50 years with no radiographic (Kellgren-Lawrence grade ≤1) and no magnetic resonance imaging (MRI) evidence of OA in the eligible knee, with no or infrequent knee pain. Incident structural knee OA (defined as tibiofemoral and/or patellofemoral OA on MRI) assessed at 48-months from intervention initiation using the MRI Osteoarthritis Knee Score (MOAKS) is the primary outcome. Secondary outcomes include knee pain, 6-min walk distance, health-related quality of life, knee joint loading during gait, inflammatory biomarkers, and self-efficacy. Cost effectiveness and budgetary impact analyses will determine the value and affordability of this intervention.DiscussionThis study will assess the efficacy and cost effectiveness of a dietary weight loss, exercise, and weight-loss maintenance program designed to reduce incident knee OA.Trial registrationClinicalTrials.gov Identifier: NCT05946044.
| S-EPMC10746515 | biostudies-literature
Project description:IntroductionThis study aimed to compare the efficacy of eccentrically focused resistance exercise (ECC RT) to concentrically focused resistance exercise (CNC RT) on knee osteoarthritis (OA) symptoms and strength.MethodsNinety participants consented. Participants were randomized to CNC RT, ECC RT, or a wait-list, no-exercise control group. Four months of supervised exercise training was completed using traditional weight machines (CNC RT) or modified-matched machines that overloaded the eccentric action (ECC RT). Main outcomes included one-repetition maximal strength (knee extension, leg flexion, and leg press), weekly rate of strength gain, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total score and subscores.ResultsFifty-four participants (60-85 yr, 61% women) completed the study. Both CNC RT and ECC RT groups showed 16%-28% improvement relative to the wait-list, no-exercise control group (P = 0.003-0.005) for all leg strength measures. The rate of weekly strength gain was greater for CNC RT than for ECC RT for leg press and knee flexion (by 2.9%-4.8%; both, P < 0.05) but not knee extension (0.7%; P = 0.38). There were no significant differences in WOMAC total and subscores across groups over time. Leg press strength change was the greatest contributor to change in WOMAC total scores (R = 0.223). The change in knee flexion strength from baseline to month 4 was a significant predictor of the change in WOMAC pain subscore (F ratio = 4.84, df = 45, P = 0.032). Both modes of strength training were well tolerated.ConclusionsBoth resistance training types effectively increased leg strength. Knee flexion and knee extension muscle strength can modify function and pain symptoms irrespective of muscle contraction type. Which mode to pick could be determined by preference, goals, tolerance to the contraction type, and equipment availability.
| S-EPMC6746593 | biostudies-literature
Project description:The rising prevalence of knee osteoarthritis is placing a considerable strain on the global healthcare system. To address this issue, telemedicine-supported multicomponent exercise therapy has emerged as a promising approach. This therapy combines exercise, patient education, and health coaching to empower knee osteoarthritis patients to manage their condition from the comfort of their homes. Nevertheless, there are some existing limitations in the current research on this approach, including challenges related to patient compliance and the absence of objective evaluation methods. Patients diagnosed with knee osteoarthritis, who have not undergone knee surgery in the past year, will be recruited for a randomized controlled trial. The trial will include an intervention group and a control group. The intervention group will receive an mHealth app-based multicomponent exercise therapy, consisting of exercise therapy, patient education, and health coaching. Meanwhile, the control group will receive usual care, involving drug therapy and patient education. The primary outcome of the trial will be the measurement of pain intensity, assessed using a visual analog scale at baseline and at 4, 8, and 12 weeks of the post-intervention. To analyze the data, a two-factor, four-level repeated measures ANOVA will be used if the assumptions of homogeneity of variance and sphericity are met. If not, a mixed effects model will be employed. The aim of the study is to evaluate the effectiveness of multicomponent exercise therapy aimed at enhancing pain self-management for knee osteoarthritis patients in the comfort of their own homes. The intervention incorporate wearable devices equipped with advanced deep learning systems to monitor patients' adherence to the prescribed at-home exercise regimen, as well as to track changes in outcomes before and after the exercise sessions. The findings from this trial have the potential to enhance both the accessibility and quality of care provided to knee osteoarthritis patients, offering valuable insights for future improvements in their treatment and management. Chinese Clinical Trials Registry, ChiCTR2300073688. Registered on 19 July 2023, https://www.chictr.org.cn/bin/project/edit?pid=199707 . World Health Organization International Clinical Trials Registry Platform, https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2300073688 .
| S-EPMC10647045 | biostudies-literature
Project description:BACKGROUND:Osteoarthritis (OA) is the most prevalent chronic joint disease, characterized by joint structural deterioration, pain and loss of function among the elders. It is also associated with several extra-articular symptoms (fatigue, sleep disorders, anxiety and depression) and a reduction of life quality. Studies have revealed that patients with OA benefitted from enhanced management via telemedicine. Guangdong Online Hospital (GOH) is the first officially recognized web-based hospital that provides telemedicine service in China. However, the effective implementation of GOH telemedicine (GOHT) to enhance management for patients with OA remains unknown. METHODS/DESIGN:An assessor-blinded, parallel randomized controlled trial will be performed to study the feasibility and effectiveness of GOHT in the enhanced management of OA. Forty participants with knee OA will be recruited for a 6-month study. Patients meeting the inclusion criteria will be randomly allocated to receive conventional therapy (CT) or conventional therapy plus a brief GOH-based intervention (CT-GOHT). The primary outcome is the feasibility of a full-scale randomized controlled trial. The secondary outcomes include the self-reported total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Multidimensional Fatigue Inventory (MFI), the Pittsburgh Sleep Quality Index (PSQI) and the Hospital Anxiety and Depression Scale (HADS). Assessments will be performed at baseline, 2 weeks, 3 months and 6 months later after the initiation of the study. DISCUSSION:This trial is intended to test the application of GOHT in the chronic management in knee OA. The hypothesis is that OA patients may receive disease management via this network platform conveniently and effectively, especially those in the remote areas of our country. GOHT telemedicine would be an attractive alternative to traditional methods for disease management in knee OA. The results could provide preliminary experiences and guidance for an upcoming full-scale randomized controlled trial (RCT) in disease management via telemedicine. TRIAL REGISTRATION:ChiCTR: ChiCTR1800014465 . Registered on 16 January 2018.
| S-EPMC5904993 | biostudies-literature
Project description:BackgroundKnee osteoarthritis has an inflammatory component that is linked to pain and joint pathology, yet common non-surgical and non-pharmacological interventions (e.g., exercise, calorie restricting diets) do not typically target inflammation. We aimed to evaluate the feasibility of a telehealth delivered anti-inflammatory diet intervention for knee osteoarthritis.MethodsThis 9-week single-arm feasibility study recruited participants aged 40-85 years with symptomatic knee osteoarthritis (inclusion criteria: average pain ≥4/10 or maximal pain ≥5/10 during past week). All participants received a telehealth-delivered anti-inflammatory dietary education intervention involving 1:1 consultations at baseline, 3- and 6-week follow-up. The diet emphasised nutrient-dense wholefoods and minimally processed anti-inflammatory foods and discouraged processed foods considered to be pro-inflammatory. The primary outcome of feasibility was assessed via: i) eligibility, recruitment and retention rates; ii) self-reported dietary adherence; iii) adverse events; and iv) treatment satisfaction. Post-intervention interviews evaluated the acceptability of the dietary intervention delivered via telehealth. Secondary outcomes included changes in self-reported body mass, Knee injury and Osteoarthritis Outcome Score (KOOS), health-related quality of life (EuroQoL-5D), analgesic use and global rating of change. Worthwhile effects were determined by the minimal detectable change (MDC) for all five KOOS-subscales (pain, symptoms, activities of daily living, sport/recreation, quality of life) being contained within the 95% confidence interval.ResultsForty-eight of seventy-three (66%) individuals screened were eligible and 28 enrolled over 2 months (82% female, mean age 66 ± 8 years, body mass index 30.7 ± 4.8 kg.m-2). Six participants withdrew prior to final follow-up (21% drop-out). Of those with final follow-up data, attendance at scheduled telehealth consultations was 99%. Self-reported adherence to diet during the 9-week intervention period: everyday = 27%, most of time = 68% and some of time = 5%. Two minor adverse events were reported. Change scores contained the MDC within the 95% confidence interval for all five KOOS subscales. Suggestions to improve study design and limit drop-out included an initial face-to-face consultation and more comprehensive habitual dietary intake data collection.ConclusionThis study supports the feasibility of a full-scale randomised controlled trial to determine the efficacy of a primarily telehealth-delivered anti-inflammatory dietary education intervention in adults with symptomatic knee osteoarthritis.Trial registrationACTRN12620000229976 prospectively on 25/2/2020.
| S-EPMC8757404 | biostudies-literature
Project description:In a pilot randomized clinical trial, participants aged ≥60 years (n = 35) with physical limitations and symptomatic knee osteoarthritis (OA) were randomized to 12 weeks of lower-body low-load resistance training with blood-flow restriction (BFR) or moderate-intensity resistance training (MIRT) to evaluate changes in muscle strength, pain, and physical function. Four exercises were performed three times per week to volitional fatigue using 20% and 60% of one repetition maximum (1RM). Study outcomes included knee extensor strength, gait speed, Short Physical Performance Battery (SPPB) performance, and pain via the Western Ontario and McMaster Universities OA Index (WOMAC). Per established guidance for pilot studies, primary analyses for the trial focused on safety, feasibility, and effect sizes/95% confidence intervals of dependent outcomes to inform a fully-powered trial. Across three speeds of movement, the pre- to post-training change in maximal isokinetic peak torque was 9.96 (5.76, 14.16) Nm while the mean difference between groups (BFR relative to MIRT) was -1.87 (-10.96, 7.23) Nm. Most other directionally favored MIRT, though more spontaneous reports of knee pain were observed (n = 14) compared to BFR (n = 3). BFR may have lower efficacy than MIRT in this context-though a fully-powered trial is needed to definitively address this hypothesis.
| S-EPMC6406824 | biostudies-literature
Project description:Obesity, and associated metabolic syndrome, have been identified as primary risk factors for the development of knee osteoarthritis (OA), representing nearly 60% of the OA patient population. In this study, we sought to determine the effects of prebiotic fibre supplementation, aerobic exercise, and the combination of the two interventions, on the development of metabolic knee osteoarthritis in a high-fat/high-sucrose (HFS) diet-induced rat model of obesity. Twelve-week-old male Sprague-Dawley rats were randomized into five groups: a non-exercising control group fed a standard chow diet, a non-exercising group fed a HFS diet, a non-exercising group fed a HFS diet combined with prebiotic fibre supplement, an exercise group fed a HFS diet, and an exercise group fed a HFS diet combined with prebiotic fibre supplement. Outcome measures included knee joint damage, percent body fat, insulin sensitivity, serum lipid profile, serum endotoxin, serum and synovial fluid cytokines and adipokines, and cecal microbiota. Prebiotic fibre supplementation, aerobic exercise, and the combination of the two interventions completely prevented knee joint damage that is otherwise observed in this rat model of obesity. Prevention of knee damage was associated with a normalization of insulin resistance, leptin levels, dyslipidemia, gut microbiota, and endotoxemia in the HFS-fed rats.
| S-EPMC6405910 | biostudies-literature
Project description:The patient was a 58-year-old African-American male with radiographic evidence of bilateral knee osteoarthritis (OA). He participated in a standardized 12-week eccentric strengthening program within a Veterans Affairs (VA) medical center.The use of an eccentric training paradigm may prove to be beneficial for older adults with knee OA since eccentric muscle actions are involved in the energy absorption at the knee joint during gait and controlled movement during stair descent. Furthermore, in comparison to standard muscle actions, eccentric muscle actions result in higher torque generation and a lower rate of oxygen consumption at a given level of perceived exertion. Therefore, this mode of progressive resistance exercise may be ideal for older adults.The patient completed an eccentric strengthening regimen for the knee flexors and extensors twice per week without an exacerbation of knee pain. Muscle morphology measures of the rectus femoris were measured using diagnostic ultrasound. Isokinetic measures of muscle peak torque were obtained at 60°/s and 180°/s. Functional performance was assessed using a physical performance battery and stair-step performance was assessed from the linear displacement of the center of gravity trajectories obtained with a force plate. Visual analog scale pain ratings and self-reported global disease status were also documented. Post-exercise assessments revealed improvements in sonographic muscle size and tissue composition estimates, peak knee extensor torque (ranging from 60 to 253%), functional performance, and global disease status.The patient exhibited improvements in muscle morphology, muscle strength, functional performance, pain, and global disease status after 12 weeks of an eccentric strengthening regimen. The intervention and outcomes featured in this case were feasible to implement within a VA medical center and merit further investigation.
| S-EPMC4497310 | biostudies-other
Project description:ObjectiveThe Intensive Diet and Exercise for Arthritis (IDEA) trial showed that an intensive diet and exercise (D+E) program led to a mean 10.6-kg weight reduction and 51% pain reduction in patients with knee osteoarthritis (OA). The aim of the current study was to investigate the cost-effectiveness of adding this D+E program to treatment in overweight and obese (body mass index >27 kg/m2 ) patients with knee OA.MethodsWe used the Osteoarthritis Policy Model to estimate quality-adjusted life-years (QALYs) and lifetime costs for overweight and obese patients with knee OA, with and without the D+E program. We evaluated cost-effectiveness with the incremental cost-effectiveness ratio (ICER), a ratio of the differences in lifetime cost and QALYs between treatment strategies. We considered 3 cost-effectiveness thresholds: $50,000/QALY, $100,000/QALY, and $200,000/QALY. Analyses were conducted from health care sector and societal perspectives and used a lifetime horizon. Costs and QALYs were discounted at 3% per year. D+E characteristics were derived from the IDEA trial. Deterministic and probabilistic sensitivity analyses (PSAs) were used to evaluate parameter uncertainty and the effect of extending the duration of the D+E program.ResultsIn the base case, D+E led to 0.054 QALYs gained per person and cost $1,845 from the health care sector perspective and $1,624 from the societal perspective. This resulted in ICERs of $34,100/QALY and $30,000/QALY. In the health care sector perspective PSA, D+E had 58% and 100% likelihoods of being cost-effective with thresholds of $50,000/QALY and $100,000/QALY, respectively.ConclusionAdding D+E to usual care for overweight and obese patients with knee OA is cost-effective and should be implemented in clinical practice.
| S-EPMC6349519 | biostudies-literature