A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women: Study Protocol for 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
- 60
- 主要终点
- Changes in trunk and hip isokinetic and isometric muscular flexion/extension peak torque, given in Newtons per meter.
研究概览
简要总结
This study is based on assess and contrast isometric and isokinetic core strength, static and dynamic balance, the number of falls, and functional autonomy in three different old women groups after a 18 weeks 1) Pilates-based structured exercise program, 2) muscular structured exercise program, and 3) nonexercising.
详细描述
Real life conditions require concurrent attention-demanding tasks, increasing the risk of falling and contributing to disability. Pilates-based exercise is proposed as a combined core and mental training program grounded on learning functionally effective postural sets and motor patterns, that will provide better results than a muscular exercise program in old women trunk strength, the risk of falling, functional autonomy and other complementary physical and mental functions. This is a 30-weeks quasi-experimental randomized controlled trial in which 80 independent old women will be allocated to a Pilates-based exercise program, a muscular exercise program, and a no-exercise control group. The intervention is divided into 18 weeks of supervised exercise and a 12 weeks follow-up. Primary outcome will be isokinetic and isometric trunk and hip flexion-extension strength, static and dynamic balance, the number of falls, and functional autonomy. Secondary outcome will include body composition, habitual physical activity and a standardized gerontological evaluation composed of body composition, daily physical activity, the independence to develop basic and instrumental activities of daily living, and the cognitive, affective and social function assessment. Every item will be measured at baseline, 18 and 30 weeks.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged from 60 to 80 years, physically and mentally able to enroll in the exercise programs. The level of education, toxic habits, medical treatment and/or diseases that can affect musculoskeletal or cardiovascular systems, mental illness, urinary incontinence, the presence of oedema and high blood pressure will be controlled.
排除标准
- •Current or prior participation in a structured Pilates-based or muscular exercise program in the past 3 months, and visual or auditory impairments not corrected with glasses or hearing aid. Each participant will also be at least 80% compliant to the exercise.
结局指标
主要结局
Changes in trunk and hip isokinetic and isometric muscular flexion/extension peak torque, given in Newtons per meter.
时间窗: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
assessed on a Biodex System III Pro Isokinetic Dynamometer (Biodex Medical System, NY, USA).
次要结局
- Changes in the Lawton and Brody's scale index to assess the independence to develop instrumental activities of daily living("Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks")
- Changes in displacement of the center of pressure (millimeters) and time spent standing on two feet, tandem and monopodal display.(Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks")
- Changes in time to accomplish the protocol GDLAM for assessing functional autonomy(Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks)
- Changes in score from the Physical Activity Scale for the Elderly (PASE) to measure habitual physical activity.("Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks")
- number of falls(participants will be followed every 4 weeks)
- Changes in the Katz scale index to assess the independence to develop basic activities of daily living("Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks")
- Changes in the Mini-Mental State score to assess the cognitive function("Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks")
- Changes in the Geriatric Depression Scale of Yesavage (GDSy) score to determine the affective function("Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks")
- Changes in time spent to accomplish the Timed Up and Go test for dynamic balance("Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks")
- Changes in bone mineral, lean mass (nonbone), and fat mass for total body, head, chest, trunk, hip, right and left legs and arms regions.("Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks")
研究者
Maria Carrasco
PhD
Universidad Católica San Antonio de Murcia