Muscle loss and fat gain contribute to the disability, pain, and morbidity associated with knee osteoarthritis (OA), and thigh muscle weakness is an independent and modifiable risk factor for it. ...However, while all published treatment guidelines recommend muscle strengthening exercise to combat loss of muscle mass and strength in knee OA patients, previous strength training studies either used intensities or loads below recommended levels for healthy adults or were generally short, lasting only 6 to 24 weeks. The efficacy of high-intensity strength training in improving OA symptoms, slowing progression, and affecting the underlying mechanisms has not been examined due to the unsubstantiated belief that it might exacerbate symptoms. We hypothesize that in addition to short-term clinical benefits, combining greater duration with high-intensity strength training will alter thigh composition sufficiently to attain long-term reductions in knee-joint forces, lower pain levels, decrease inflammatory cytokines, and slow OA progression.
This is an assessor-blind, randomized controlled trial. The study population consists of 372 older (age ≥ 55 yrs) ambulatory, community-dwelling persons with: (1) mild-to-moderate medial tibiofemoral OA (Kellgren-Lawrence (KL) = 2 or 3); (2) knee neutral or varus aligned knee ( -2° valgus ≤ angle ≤ 10° varus); (3) 20 kg.m-2 ≥ BMI ≤ 45 kg.m-2; and (3) no participation in a formal strength-training program for more than 30 minutes per week within the past 6 months. Participants are randomized to one of 3 groups: high-intensity strength training (75-90% 1Repetition Maximum (1RM)); low-intensity strength training (30-40%1RM); or healthy living education. The primary clinical aim is to compare the interventions' effects on knee pain, and the primary mechanistic aim is to compare their effects on knee-joint compressive forces during walking, a mechanism that affects the OA disease pathway. Secondary aims will compare the interventions' effects on additional clinical measures of disease severity (e.g., function, mobility); disease progression measured by x-ray; thigh muscle and fat volume, measured by computed tomography (CT); components of thigh muscle function, including hip abductor strength and quadriceps strength, and power; additional measures of knee-joint loading; inflammatory and OA biomarkers; and health-related quality of life.
Test-retest reliability for the thigh CT scan was: total thigh volume, intra-class correlation coefficients (ICC) = 0.99; total fat volume, ICC = 0.99, and total muscle volume, ICC = 0.99. ICC for both isokinetic concentric knee flexion and extension strength was 0.93, and for hip-abductor concentric strength was 0.99. The reliability of our 1RM testing was: leg press, ICC = 0.95; leg curl, ICC = 0.99; and leg extension, ICC = 0.98. Results of this trial will provide critically needed guidance for clinicians in a variety of health professions who prescribe and oversee treatment and prevention of OA-related complications. Given the prevalence and impact of OA and the widespread availability of this intervention, assessing the efficacy of optimal strength training has the potential for immediate and vital clinical impact.
ClinicalTrials.gov, NCT01489462.
To identify problems at different treatment points (early treatment, mid-treatment, early posttreatment, and late posttreatment) among women with ovarian cancer.
Longitudinal and cross-sectional ...study design.
An academic and community clinical cancer center in the Southeastern United States.
Sixty-eight women with Stage I to IV ovarian cancer.
Variables assessed included reported problems (physical, psychosocial, pain, marital, medical interaction), social support, optimism, and responses to open-ended questions. Analysis involved mixed models for longitudinal repeated measures and unpaired t tests and content analysis to describe responses to open-ended questions.
Physical and psychosocial problems were greatest during early treatment and decreased throughout the treatment trajectory. Women with greater levels of social support and optimism at baseline had fewer problems over time. Women who did not have trouble paying for basics had fewer problems related to pain and psychological problems.
Problems across all domains must be addressed throughout the treatment trajectory, even after chemotherapy has ended. Nurses are well positioned to refer women appropriately to social workers and clinical navigators across all domains of care and should consider systematic assessment of patient-reported problems as a routine form of practice.
Osteoarthritis (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.
The 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.
This 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.
ClinicalTrials.gov Identifier: NCT05946044.
Physical activity decreases the risk of osteoarthritis (OA)-related disability; however, pain and lack of confidence represent barriers for older adults with knee OA. The purpose of this study was to ...examine (a) the baseline associations among self-efficacy and physical activity, function, and pain; (b) longitudinal changes in self-efficacy; and (c) whether self-efficacy mediates treatment effects on clinical outcomes. The Intensive Diet and Exercise for Arthritis (IDEA) trial was a single-blind, randomized controlled 18-month study including 454 overweight/obese older adults (M age = 66 years) with knee OA. Participants were randomized to one of three interventions: exercise (E), diet-induced weight loss (D), or both (D+E). Self-efficacy for gait, balance, and walking duration were assessed at baseline, 6 months, and 18 months. Baseline associations were tested using Pearson correlations, and group least squares means were compared using mixed linear models at follow-up. Participants with higher self-efficacy reported significantly better physical function and less knee pain at baseline, walked farther (6-min walk), and were more physically active (all |r| > 0.12, all p < .01). Significant differences between groups were detected for all self-efficacy measures at 18 months; the D+E group reported significantly (all p < .005) higher self-efficacy for gait, walking duration, and balance compared with the D- or E-only groups. Self-efficacy significantly (p < .05) mediated treatment effects on physical function and pain at 18 months. A combined intervention of diet-induced weight loss and exercise is the treatment of choice to maximize self-efficacy, improve physical function, and reduce pain in overweight/obese adults with knee OA.
Using the weight efficacy lifestyle questionnaire (WEL), we examined whether a group-mediated intervention for weight loss among older, obese adults resulted in changes in self-regulatory ...self-efficacy for eating behavior and whether these changes mediated weight loss.
This was a randomized controlled design, and 288 older adults received 1 of 3 treatments for 6 months: physical activity only (PA), weight loss + physical activity (WL + PA), or a successful aging (SA) health education program. The WEL was administered prior to randomization and again at the 6-month follow-up visit.
A significant treatment effect was observed for the WEL, F (2249) = 15.11, p < .0001, partial eta2 = .11, showing that improvement occurred only in the WL + PA group as compared with PA and SA. Changes in WEL scores partially mediated the effects of the WL + PA intervention on weight loss.
These results illustrate that WL + PA can be effective in improving older adults' self-efficacy for the self-regulation of eating behavior and that these changes are prospectively related to the amount of weight loss. Further research is warranted on an expanded concept of self-efficacy as well as controlled experimental studies on eating behavior in older adults.
Context
:
While 55 million Americans incorporate running into their exercise routines, up to 65% of runners sustain an overuse injury annually. It has been consistently shown that regular physical ...activity positively impacts quality of life (QOL), an essential public health indicator; however, the impact of running-related injuries on QOL is unknown. This study seeks to determine whether overuse injury severity impacts QOL in recreational runners, and if self-efficacy mediates this relationship.
Design
:
Community-based prospective cohort study of 300 runners who had been running injury free for at least 5 miles/wk in the past 6 months.
Methods
:
Self-efficacy for running and QOL measures (Short Form-12 Physical Component and Mental Component, Satisfaction with Life, Positive Affect and Negative Affect) were assessed at baseline, time of injury, and follow-up visits. Over 2 years of observation, overuse injuries were diagnosed by an orthopedic surgeon and injured runners were referred to a physical therapist.
Results
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Injury severity was significantly (
P
< .01) related with 2 indices of QOL, such that the effect of injury severity was −2.28 units on the Short Form-12 physical component and −0.73 units on positive affect. Self-efficacy accounted for 19% and 48% of the indirect effects on Short Form-12 physical component and positive affect, respectively.
Conclusions
:
Since self-efficacy is a modifiable factor related to decreased QOL, these findings have important clinical implications for rehabilitation interventions.
Reducing symptom burden is often secondary to risk factor control in diabetes. Symptom burden with comorbid medical conditions and the need for symptom palliation are not well defined. Although ...neuropathy is one of the most frequent occurring comorbidities of diabetes, patient experience is inconsistent. Using in-depth interview, we assessed patients' perspectives of pain experienced through neuropathy and the impact on type 2 diabetes management. Areas covered: Participants completed a structured telephone interview during which perspectives on diabetes and its management occurred. Data were analyzed iteratively using content analysis and extracted themes came from reduced data. Interview data were triangulated with clinical data from electronic health records. Expert opinion: During interviews, 41% of patients reported pain interfered with their lives. Three pain-related themes emerged from interviews, augmented by descriptions of how people experience and cope with pain. Themes included: (1) people know what neuropathy is and attribute their pain to it; (2) neuropathic pain seems insurmountable at times; and (3) pain can lead to feeling down or hopeless. Pain, a common comorbidity in diabetes, is a primary driver of patient suffering. Understanding how patients experience pain paves the way for creative interventions to manage it better among those living with diabetes.
Recently, we determined that in a rigorously monitored environment an intensive diet-induced weight loss of 10% combined with exercise was significantly more effective at reducing pain in men and ...women with symptomatic knee osteoarthritis (OA) than either intervention alone. Compared to previous long-term weight loss and exercise trials of knee OA, our intensive diet-induced weight loss and exercise intervention was twice as effective at reducing pain intensity. Whether these results can be generalized to less intensively monitored cohorts is unknown. Thus, the policy relevant and clinically important question is: Can we adapt this successful solution to a pervasive public health problem in real-world clinical and community settings? This study aims to develop a systematic, practical, cost-effective diet-induced weight loss and exercise intervention implemented in community settings and to determine its effectiveness in reducing pain and improving other clinical outcomes in persons with knee OA.
This is a Phase III, pragmatic, assessor-blinded, randomized controlled trial. Participants will include 820 ambulatory, community-dwelling, overweight and obese (BMI ≥ 27 kg/m
) men and women aged ≥ 50 years who meet the American College of Rheumatology clinical criteria for knee OA. The primary aim is to determine whether a community-based 18-month diet-induced weight loss and exercise intervention based on social cognitive theory and implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain in overweight and obese adults with knee OA relative to a nutrition and health attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, mobility, and is cost-effective.
Many physicians who treat people with knee OA have no practical means to implement weight loss and exercise treatments as recommended by numerous OA treatment guidelines. This study will establish the effectiveness of a community program that will serve as a blueprint and exemplar for clinicians and public health officials in urban and rural communities to implement a diet-induced weight loss and exercise program designed to reduce knee pain and improve other clinical outcomes in overweight and obese adults with knee OA.
clinicaltrials.gov Identifier: NCT02577549 October 12, 2015.
A randomized controlled trial examined the growth and form of multidimensional self-esteem over a 12-month period (6-month exercise intervention and 6-month follow-up) in 174 older adults engaged in ...either a walking or stretching/toning program. The extent to which changes in physical fitness parameters and physical self-efficacy were related to changes in perceptions of attractive body, strength, physical conditioning, and physical self-worth was also determined. Latent growth curve analyses showed a curvilinear pattern of growth in esteem with significant increases at all levels of self-esteem upon completion of the intervention followed by significant declines at 6 months postintervention in both groups. Frequency of activity and changes in physical fitness, body fat, and self-efficacy were related to improvements in esteem perceptions relative to attractive body, strength, and physical condition. Model fitting procedures suggested that the best fit of the data was to a model in which the influence of changes in efficacy and physical parameters on physical self-worth were mediated by perceptions of attractive body and physical condition.
Cancer treatment increases cardiovascular disease risk, but physical activity (PA) may prevent cardiovascular disease.
This study examined whether greater PA was associated with better submaximal ...exercise capacity and cardiac function during cancer therapy.
Participants included 223 women with stage I to III breast cancer (BC) before and 3 months after undergoing treatment and 126 control participants. Leisure-time PA (LTPA) was reported using the Godin-Shephard LTPA questionnaire. Cardiac function was assessed by cardiac magnetic resonance. Submaximal exercise capacity was determined by 6-minute walk distance.
BC participants reported similar baseline LTPA scores (24.7; 95% CI: 21.7-28.0) as control participants (29.4; 95% CI: 25.0-34.2). The BC group declined to 16.9 (95% CI: 14.4-19.6) at 3 months relative to 30.8 (95% CI: 26.2-35.8) in control participants. Among BC participants, more LTPA was related to better exercise capacity (β ± SE: 7.1 ± 1.6; 95% CI: 4.0-10.1) and left ventricular (LV) circumferential strain (−0.16 ± 0.07; 95% CI: −0.29 to −0.02). Increased LTPA over the 3 months was associated with decreased likelihood of treatment-induced cardiac dysfunction according to LV circumferential strain classifications (OR: 0.98; 95% CI: 0.97-0.998). BC participants reporting insufficient LTPA according to PA guidelines exhibited deteriorations in exercise capacity (adjusted mean difference ± SE: −29 ± 10 m; P = 0.029), LV end-systolic volume (5.8 ± 1.3 mL; P < 0.001), LV ejection fraction (−3.2% ± 0.8%; P = 0.002), and LV circumferential strain (2.5% ± 0.5%; P < 0.001), but BC participants meeting LTPA guidelines did not exhibit these adverse changes.
PA declined during BC therapy; however, PA participation was associated with attenuated declines in exercise capacity and cardiac function that are often observed in this population. (Understanding and Predicting Breast Cancer Events After Treatment WF97415 UPBEAT; NCT02791581)
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