The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Change from baseline cardiorespiratory endurance to 3 month, assessed by Six Minutes' Walk test.
研究概览
简要总结
The PLE²NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a self-management and exercise program specific for elderly with knee osteoarthritis (OA), with the goals of managing OA symptoms, improving physical fitness, and developing self-efficacy and self-management of pathology.
详细描述
Participants were randomly assigned to one of two groups: (1) Self-management and Exercise (2) Educational. Both groups received glucosamine and chondroitin sulfate supplement during the intervention. Blinding of participants was not possible due to the nature of the intervention; however, assessors were blinded to group allocation. The PLE2NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a community-based program with two components: self-management and exercise. Each session lasted 90 minutes, and the first 30 minutes corresponded to a self-management part and the remaining 60 minutes to the exercise program. The program was offered in a group format, encouraging peer interactions and socialization that can help counteract feelings of depression and isolation. The self-management program is based on the program developed at Stanford University, the Chronic Disease Self-Management Program which the purpose is developing self-efficacy based on social cognitive theory. The exercise program comprised both health related (strength, flexibility) and skill-related (agility, balance, speed and power) physical fitness components, and was based on Fit an Strong Program, on Exercise for People with Arthritis (FEPA) and also on the program Takin Control with Exercise (Arthritis Foundation). The program will last for 3 months and 6 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over than or equal to 60 years;
- •Bilateral or unilateral OA of the knee diagnosed according to clinical and radiological criteria of the American College of Rheumatology (ACR)(Altman et al., 1986);
- •Independent mobility;
- •and reading and writing knowledge.
排除标准
- •Not be involved in another intervention program (exercise, education or physical therapy;
- •Do not use supplements (chondroitin sulfate and / or glucosamine) for at least three months;
- •Have other pathology (cardiovascular, respiratory, musculoskeletal, cancer) that prevents physical exercise;
- •Mental / psychological state hindering understanding of the program;
- •Having undergone surgery for knee replacement or going perform this surgery in the next eight months;
- •Being allergic to shellfish;
- •Have made injections of corticosteroids or hyaluronic acid in the last 6 months
研究组 & 干预措施
Self-Management and exercise
干预措施: Self-Management and exercise (Device)
Educational
干预措施: Educational (Device)
结局指标
主要结局
Change from baseline cardiorespiratory endurance to 3 month, assessed by Six Minutes' Walk test.
时间窗: Change from baseline to 3 month
Change from baseline knee OA symptoms to 3 month, assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire.
时间窗: Change from baseline to 3 month
Change from baseline self-efficacy to 3 month, assessed by Self-efficacy for managing Chronic Disease - 6-Item Scale questionnaire.
时间窗: Change from baseline to 3 month
Change from baseline functional strength to 3 month, assessed by Five repetition sit to stand test.
时间窗: Change from baseline to 3 month
Change from baseline flexibility to 3 month, assessed by Chair Sit and Reach test, and the Back Scratch test.
时间窗: Change from baseline to 3 month
Change from baseline hand grip strength to 3 month, assessed by hand grip dynamometer test.
时间窗: Change from baseline to 3 month
次要结局
- Change from baseline gait speed to 3 month, assessed by Six-meters test.(Change from baseline to 3 month)
- Change from baseline mobility to 3 month, assessed by Timed "up-and-go" test.(Change from baseline to 3 month)
- Change from baseline health related quality of life to 3 month, assessed by perception of health and quality of life five dimension, five levels (EuroQol - EQ-5D-5L) questionnaire.(Change from baseline to 3 month)
- Change from baseline self-management behaviors to 3 month, Use of cognitive symptom management techniques, Communication with Physicians questionnaires.(Change from baseline to 3 month)
- Change from baseline physical activity level to 3 month, assessed by International Physical Activity Questionnaire (IPAQ).(Change from baseline to 3 month)
- Change from baseline balance to 3 month, assessed by Standing Balance test.(Change from baseline to 3 month)
研究者
Priscila Marconcin
Master degree
Technical University of Lisbon