Comparison of the Effectiveness Between Land and Water Exercises on Isokinetic Muscle Strength of Lower Limbs in Women With Rheumatoid Arthritis: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Muscle strength
研究概览
简要总结
The interest in studying the impact of aquatic exercise on muscle strength of patients with rheumatoid arthritis came after publication of several studies that pointed to the potential benefit of exercise on the natural history of the disease, including reduction of pain, better immune response as well as aerobic fitness and functional capacity and increase muscle strength, endurance and quality of life.
In general, the aquatic exercises are indicated for patients with chronic joint diseases, since the aquatic environment seems to be more secure for this population due to the reduction of joint loading, as well as gain range of motion.
However, there are some difficulties to show the real and consistent beneficial effect of physical activity in these patients, such as the small number of randomized controlled clinical trials, short intervention period (4-8 weeks), lack of details of the exercise protocols used, methodological problems (heterogeneous measures to evaluate the outcome, change of medication). Moreover, no study evaluated the disease activity, according to the tool most used clinically worldwide, the DAS28.
It is known that aquatic exercises without impact in healthy subjects are sufficient to gain muscle strength. Nonetheless, in people with joint limitation the benefits from these same exercises to gain muscle strength is not known.
To date, no studies addressing the effect of aquatic exercise on muscle strength and disease activity in patients with rheumatoid arthritis. In addition, there is the need to obtain a standardized protocol for prescribing of aquatic exercises. The choice of lower-limb strength was based on its relevance to the acceleration and deceleration during the march, as well as to perform activities of daily living, leisure and professional in these individuals.
Thus, this study aims at:
- Exercises performed in the aquatic environment and without the concomitant use of overhead equipment are sufficient to promote gain muscle strength in the lower limb?
- What is the isolated effect of water resistance on muscle strength? Could it work as an impact that is used in exercises done on the land?
详细描述
The investigators objectives are:
- To compare the peak torque of flexor and extensor of the knee between land and water exercises in women with rheumatoid arthritis. This is a randomized controlled clinical trial with 16 weeks of length;
- To verify the changes of disease activity, functional capacity and body composition measurements before and after the intervention
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pre- or postmenopausal;
- •Disease Activity: from mild to moderate, according to the DAS28;
- •Functional class I and II Steinbrocker;
- •No rehabilitation program in the last three months;
- •Stable medication in the three months before randomization;
- •Cardiorespiratory fitness after exercise testing and cardiologic exam;
- •Agree and sign the Instrument of Consent;
排除标准
- •Circulatory problems, ulcers in the legs, or other untreated skin lesions that would preclude the exercise in the pool;
- •Physical activity regularly in the three months prior to intervention;
- •Use of orthoses or any other devices;
- •Hip or knee prosthesis;
- •Regular use of proteic supplements or anabolic drugs;
- •Orthopedic surgery scheduled for the next six months;
- •Intra-articular infiltration in the three months prior to randomization or scheduled for the next six months;
- •Illiteracy and cognitive impairment;
- •Hearing loss and visual;
- •Phobia of water;
- •Hypersensitivity to the chlorine;
- •Epilepsy and urinary or fecal incontinence;
- •Any uncontrolled chronic illness.
结局指标
主要结局
Muscle strength
时间窗: 16 weeks
Isokinetic muscle strength
次要结局
- Disease Activity Score (DAS28)(16 weeks)
- Health Assessment Questionnaire (HAQ)(16 weeks)
- Body composition measurements(16 weeks)
研究者
Marcelo M Pinheiro
Clinical Professor
Federal University of São Paulo