The Effects of a Multi-component Intervention on the Functional Capacity, Upper and Lower-body Muscle Strength, Balance and Gait in Frail Community-dwelling Older People: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- strength muscle evaluation
研究概览
简要总结
This study evaluates if a multi-component intervention, respecting the characteristics of frail older person and increasing intensity and challenge of exercises according to frail older person capacity/evolution will induce better functional results than a multi-component intervention specific to lower body. the volunteers will be randomized into experimental group and control group.
详细描述
The interventions are separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes, beginning with a warming up. In the table are described the exercise as well as the support necessary to perform the exercise safely and necessary equipment (accessories). In cases where a minimum load is required the same are also described in the multimodal intervention protocol (load).
In relation to strength training in the multimodal intervention protocol is described how the progression of intensity will be held. Additional to the load progression suggested, the 1 maximal repetition test will be applied every 4 weeks for adjustment of the loads according to strength gain from each volunteer.
The suggested protocol is based on balance exercises and strength but, in a careful manner, were included functional and mobilization exercises to ensure greater diversity.
Multimodal intervention protocol:
- a week
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 (Care Provider)
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
- •volunteers above the age of 65 who are community residents and classified as frail according to the criteria established by Fried et al. will be selected for inclusion in the study
排除标准
- •previous lower extremities orthopedic surgery, a history of fractures within the past year, an inability to walk unaided, carriers of neurological diseases, diagnosed acute inflammatory disease that could interfere in the assessments and the program, tumor growth in the last five years and cognitive impairment based on the mini-mental state examination [4]. Moreover, will be excluded volunteers who are absent more than three consecutive training and / or more than 25% of the sessions, and / or present the course of the physical program changes or decompensation and / or disease injury.
研究组 & 干预措施
Exercise Group
The multimodal intervention protocol is described separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes.
干预措施: Exercise - FOURTH PHASE (Other)
Exercise Group
The multimodal intervention protocol is described separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes.
干预措施: Exercise - THIRD PHASE (Other)
Exercise Group
The multimodal intervention protocol is described separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes.
干预措施: Exercise - FIRST PHASE (Other)
Exercise Group
The multimodal intervention protocol is described separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes.
干预措施: Exercise - SECOND PHASE (Other)
Control Group
Participants from the control group will not perform any kind of physical exercise.
结局指标
主要结局
strength muscle evaluation
时间窗: baseline
The Elbow flexors and extensors, trunk flexors and extensors, hip abductor and adductor, knee flexors and extensors and ankle dorsiflexors and plantarflexors muscle strength of the dominant limb will be evaluated by an isokinetic dynamometer
gait
时间窗: baseline
The gait parameters will be analyzed using the GAITRite Platinum 26' Portable Walkway System to evaluated spatial and temporal gait variables.
Balance
时间窗: baseline
Balance in semi-static stance was measured using the force platform. Data on 6 stances were collected for each subject: standing on a fixed platform with eyes open and closed; standing on an unstable platform with eyes open and closed; and in single-leg stance with eyes open on the right leg and on the left leg.
functional performance
时间窗: baseline
Timed Up and Go (TUG) test will be used.
次要结局
- gait(change from baseline in 3 months)
- Balance(change from baseline in 3 months)
- functional performance(change from baseline in 3 months)
- strength muscle evaluation(change from baseline in 3 months)
研究者
Prof Daniela Cristina Carvalho de Abreu
Professor
University of Sao Paulo