RESUMO
Importance: Some weight loss and exercise programs that have been successful in academic center-based trials have not been evaluated in community settings. Objective: To 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 Participants: Assessor-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. Interventions: Patients 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 Measures: The 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. Results: Among 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 Relevance: Among 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 Registration: ClinicalTrials.gov Identifier: NCT02577549.
Assuntos
Artralgia , Osteoartrite do Joelho , Sobrepeso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade/complicações , Obesidade/terapia , Osteoartrite do Joelho/complicações , Osteoartrite do Joelho/terapia , Sobrepeso/complicações , Sobrepeso/terapia , Artralgia/dietoterapia , Artralgia/etiologia , Artralgia/terapia , IdosoRESUMO
BACKGROUND: 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. METHODS/DESIGN: This is a Phase III, pragmatic, assessor-blinded, randomized controlled trial. Participants will include 820 ambulatory, community-dwelling, overweight and obese (BMI ≥ 27 kg/m2) 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. DISCUSSION: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02577549 October 12, 2015.
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Terapia por Exercício , Osteoartrite do Joelho/terapia , Sobrepeso/dietoterapia , Manejo da Dor/métodos , Redução de Peso , Ensaios Clínicos Fase III como Assunto , Feminino , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , North Carolina , Osteoartrite do Joelho/complicações , Sobrepeso/complicações , Dor/etiologia , Medição da Dor , Ensaios Clínicos Pragmáticos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Recuperação de Função Fisiológica , Autorrelato , Resultado do TratamentoRESUMO
OBJECTIVE: The purpose of this study was to determine whether clinical, health-related quality of life (HRQL), and gait characteristics in adults with knee osteoarthritis (OA) differed by obesity category. METHODS: This cross-sectional analysis of 823 older adults (mean age 64.6 years, SD 7.8 years) with knee OA and overweight or obesity compared clinical, HRQL, and gait outcomes among obesity classifications (overweight or class I, body mass index [BMI] 27.0-34.9; class II, BMI 35.0-39.9; class III BMI ≥40.0). RESULTS: Patients with class III obesity had worse Western Ontario McMasters Universities Arthritis Index knee pain (0-20) than the overweight or class I (mean 8.6 vs 7.0; difference 1.5; 95% confidence interval [CI] 1.0-2.1; P < 0.0001) and class II (mean 8.6 vs 7.4; difference 1.1; 95% CI 0.6-1.7; P = 0.0002) obesity groups. The Short Form 36 physical HRQL measure was lower in the class III obesity group compared to the overweight or class I (mean 31.0 vs 37.3; difference -6.2; 95% CI -7.8 to -4.7; P < 0.0001) and class II (mean 31.0 vs 35.0; difference -3.9; 95% CI -5.6 to -2.2; P < 0.0001) obesity groups. The class III obesity group had a base of support (cm) during gait that was wider than that for the overweight or class I (mean 14.0 vs 11.6; difference 3.3; 95% CI 2.6-4.0; P < 0.0001) and class II (mean 14.0 vs 11.6; difference 2.4; 95% CI 1.6-3.2; P < 0.0001) obesity groups. CONCLUSION: Among adults with knee OA, those with class III obesity had significantly higher pain levels and worse physical HRQL and gait characteristics compared to adults with overweight or class I or class II obesity.
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Osteoartrite do Joelho , Humanos , Idoso , Pessoa de Meia-Idade , Osteoartrite do Joelho/diagnóstico , Osteoartrite do Joelho/epidemiologia , Sobrepeso , Qualidade de Vida , Estudos Transversais , Obesidade/complicações , Obesidade/diagnóstico , Marcha , Dor , Índice de Massa CorporalRESUMO
This study used behavioral assessment techniques to analyze pain in osteoarthritis (OA) patients. Eighty-seven OA patients having chronic knee pain served as subjects. Pain behavior was evaluated using a standard observation method and functional impairment was assessed using the Arthritis Impact Measurement Scales. Data analysis revealed that pain and limitations in physical activities were the most common functional impairments and that the most frequently observed pain behavior was guarded movement. Predictive analyses indicated that disability support status and scores on a Pain Control and Rational Thinking factor of the Coping Strategies Questionnaire (CSQ) were predictive of functional impairment. Patients receiving disability support payments were much more functionally limited than those not receiving this financial support. Patients scoring high on the Pain Control and Rational Thinking factor of the CSQ were much less functionally impaired, walked a 5 m course more rapidly and moved from a standing to a sitting or reclining position more quickly than patients scoring low on this factor. The implications of these results for behavioral treatment of OA knee pain are discussed.
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Comportamento , Articulação do Joelho , Osteoartrite/psicologia , Dor/psicologia , Adaptação Psicológica , Doença Crônica , Condicionamento Operante , Pessoas com Deficiência/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade/fisiopatologia , Osteoartrite/fisiopatologia , Dor/etiologia , Previdência Social , Estados UnidosRESUMO
This report describes a visit by an international group interested in Rheumatology to the Rheumatology centers and traditional Chinese medicine units in the People's Republic of China. Differing disease patterns and treatment approaches offer opportunities for studies and collaborations. We can also learn from the traditional Chinese approach with individualization of therapy and attention to health maintenance.