Comparison of the Effect on Functionality of Multicomponent Training With and Without Action Observation in Older Adults.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 主要终点
- Short Physical Performance Battery (SPPB)
研究概览
简要总结
Randomised clinical trial involving 58 independent subjects of both sexes who attended the Geriatric Revitalisation Programme run jointly by the University of Salamanca and the Salamanca City Council. At the beginning and at the end of the programme, data were collected on participants' balance, fall risk and other parameters, using anthropometric tests (weight, % body fat and body mass index (BMI)), and physical performance tests (grip strength, the Short Physical Performance Battery, TUG and the stair step test). Study participants performed three 50-minute sessions per week for a total of 35 weeks. The components of balance, gait, cardiovascular resistance, stability, upper and lower limb strength, flexibility and breathing exercises were worked on. In the OC group, the physiotherapist performed the entire session together with the participants, while in the other group, the physiotherapist simply ordered the exercises.
详细描述
Design: Randomised, controlled clinical trial with two parallel groups, in which adults over 65 years of age will be recruited. Study participants will be assigned to one of the two interventions. The study will have a duration of 35 weeks. There will be 2 evaluation visits, one initial, one final. During the intervention period there will be 3 weekly sessions of 50 minutes.
Scope: The study will be carried out in the Health Area of Salamanca, in collaboration with the Research, Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council.
Interventions: 1) Multicomponent Exercise Group (GEM); 2) Multicomponent Exercise and Action Observation Group (GOA). The GEM and GOA sessions follow the same design, according to the recommendations of the American College of Sports Medicine (ACSM), the only difference being that in the GOA the physiotherapist will perform all the exercises with the participants.
Study population: Adults over 65 years of age from the city of Salamanca will be included, distributed in 2 groups in a 1:1 ratio. Randomisation will be performed using the Epidat 4.2 programme. The sample size was calculated using GRANMO Version 7. 12 April 2012.
The main study variables are: Functionality (Timed Up & Go test (TUG), chair stand test (CS), hand grip test (HG) and Short Physical Performance Battery (SPPB)), gait speed (GS). stair step test; and body composition (% body fat, body weight, body mass index (BMI)).
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Single blind masking with blinded assessor.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults over 65 years of age.
排除标准
- •Pacemakers
- •Fibrillations
- •Cardiac pathology or uncontrolled hypertension
- •History of severe trauma/recent cervical surgery
- •Uncontrolled systemic and inflammatory pathologies
- •Congenital collagen compromise
- •Presence of difficulties in performing the Initial Evaluation tests
- •Language barriers
- •Pending litigation or legal claim
结局指标
主要结局
Short Physical Performance Battery (SPPB)
时间窗: thirty-five weeks
Test to assess physical performance and degree of frailty consisting of 3 subtests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.
次要结局
- Gait speed(thirty-five weeks)
- Timed Up and Go (TUG)(thirty-five weeks)
- Grip strength test(thirty-five weeks)
- Body Mass Index (BMI)(thirty-five weeks)
- Body fat percentage(thirty-five weeks)
- Chair stand test(thirty-five weeks)
- Step-Up Box Test(thirty-five weeks)
研究者
Luis Polo Ferrero
Associate Professor
University of Salamanca