Effectiveness of Health Education Compared to Aquatic Physical Therapy for Patients With Knee Osteoarthritis: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The purpose of this study is to determine whether education or aquatic physical therapy are effective in the treatment of osteoarthritis in Knee due to intensity of pain, function capacity, quality of life and kinetic.
详细描述
Sixty patients will be recruited from clinics and through printed newspaper. Physicians who routinely evaluate patients with this diagnosis will be informed of the study, and the same will be announced by television call.
After passing a medical examination confirming the clinical diagnosis of knee osteoarthritis by American College of Rheumatology and other criteria, the elect will be informed of the objectives of the study and invited to participate.
After evaluation of the records of referrals of knee OA, patients receive phone calls, will be informed of the research objectives, questioned regarding the inclusion and exclusion criteria of the study and invited to participate in the study.
Upon study entry, personal information (name, age, gender, address and telephone) will be confirmed by a secretary, who will give the registration number of the patient. Personal information, as well as their radiographs, will be kept in personal form, with number of study enrollment.
Before and after implementation of treatment protocols, as well as after three months, all patients will be assessed by an independent examiner, ie, that have no knowledge about the intervention with respect to different variables. The independent examiner will have been previously trained for this role to become fit to do so.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 60 and 85 years;
- •patients with knee OA by a physician confirmed by the criteria of American College of Rheumatology;
- •patients with clinical and cognitive activities for the realization of the pool conditions, confirmed by the Mini-Exam Mental state.
排除标准
- •patients undergoing surgical procedures in the last six months;
- •patients with chronic diseases such as coronary, other rheumatic diseases such as rheumatoid arthritis; serious diseases such as cancer; chronic obstructive pulmonary diseases; uncontrolled hypertensive;
- •patients unable to walk without aid equipment;
- •patients who have contraindications to practice exercises;
- •patients who have contraindications for entry into the pool, such as urinary or fecal incontinence and skin problems;
- •patients participating in nutrition programs or physical activity in the last two months (or resisted aerobic activity more than once a week for at least two months);
- •patients with metal implants in the lower limbs;
- •patients with morbid obesity (body mass index (BMI)> 40 kg / m 2);
- •Patients unable to continue the study by programmed change of address or hospitalization.
结局指标
主要结局
Pain
时间窗: up to 3 months
Evaluation of pain - EVA
次要结局
- Function(2 and 3 months)
- kinetic(2 and 3 months)
- Balance(2 and 3 months)
- Quality Of Live(2 and 3 months)
研究者
Jefferson Rosa Cardoso
Ligia Maria Facci
Universidade Estadual de Londrina