CREM - Reference Center for Aging and Movement: Clinical and Functional Outcomes in a Controlled Clinical Trial with Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- Lower Limb Strength
研究概览
简要总结
To evaluate and compare the effects of different types of physical exercise on clinical and functional outcomes in the elderly. 240 community-dwelling elderly individuals of both sexes, sedentary, will be recruited for twelve groups of elderly individuals who will receive intervention for 32 weeks of different types of physical exercise (free walking, Nordic walking, dancing, physical exercise for cognition, balance, aquatic physiotherapy, multicomponent gymnastics, water aerobics, hydro-postural exercises, aquatic jogging, weight training, and Pilates mat). The training programs will have a frequency of two sessions per week and will last 50 minutes and will be periodized so that the duration of the sessions is equal among them. In order to evaluate the effects of the training, evaluations will be carried out before, during and after the training period of functional fitness, clinical-functional and biomechanical parameters. It is expected that the intervention groups will present results according to the nature of the modality and that they will be more effective when compared to the control group. As well as improvements in the variables of gait speed, muscle strength, balance and cognition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elderly people over 60 years old,
- •sex female our male,
- •presenting medical authorization to practice exercises,
- •being able to understand verbal instructions for carrying out the tests,
- •having accessibility to carry out the training,
- •coming from local Health Units and the community,
- •presenting independent walking and not having participated in any physical activity for at least three months before starting the research.
排除标准
- •not having a medical certificate indicating that they are fit to perform physical activity,
- •presenting medical comorbidities and/or a medical condition that contraindicates participation in the study, severe heart disease, uncontrolled arterial hypertension, myocardial infarction within a period of less than one year or history of physical-cognitive impairment, sequelae of a stroke,
- •having a pacemaker,
- •having undergone recent surgery,
- •prosthetics in the lower limbs or neuropathic pain in the lower limbs.
结局指标
主要结局
Lower Limb Strength
时间窗: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
Five-Repetition Sit-to-Stand Test - This assesses the time it takes for an individual to stand up so that their knees are fully extended and then sit down again as quickly as possible. Individuals with 5-repetition times for this test greater than the following may be considered to have poorer than average performance: 11.4 sec (60 to 69 years), 12.6 sec (70 to 79 years), and 14.8 sec (80 to 89 years).
Upper limb strength
时间窗: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
Dynamometry - Obtained using a hand-held dynamometer. The subject is seated and asked to exert as much force as possible with the dominant upper limb. The highest strength value obtained will be considered, adjusted by the body mass index (in quartiles) and stratified by sex.
Upper limb flexibility
时间窗: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
Reach Behind the Back - While standing, the subject places the preferred hand on the same shoulder, palm open and fingers extended, reaching as far as possible toward the middle of the back. The hand of the other arm is placed behind the back, palm up, reaching as far as possible, in an attempt to touch or overlap the extended middle fingers of the other hand. Measured in distance (cm).
Lower limb flexibility
时间窗: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
Sitting and Reaching - The subject remains seated in the chair and with one leg extended, tries to reach the toes, it is measured in distance (cm).
Aerobic endurance
时间窗: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
6-Minute Walk Test - On a 30-meter course, participants walk as fast as possible (without running) around the course as many times as they can within the time limit, it is measured in distance (m) and reflects aerobic endurance
Static balance
时间窗: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
Single-leg support tests - Static balance tests (Single-leg 30 seconds). The ability of subjects to stand on the force platform in a single-leg position with their eyes open. The position is standing on one foot (single-leg support), the subject chooses whether the right or left leg, looking at a fixed point in line with the eyes. The task is timed until the subjects return the foot to the ground or reach the maximum time of 30 seconds. The force platform will be used and the rate of displacement of the COP will be analyzed in the anteroposterior (Fx), mediolateral (Fy) and vertical (Fz) axes.
Dynamic balance
时间窗: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
Timed and Up and Go (TUG) - The patient starts by sitting in a chair, walks a distance of 3 meters, goes around a cone (180º turn), returns and sits back down in the chair. The patient is instructed to perform the test as quickly as possible. For classification: test performed in up to 10 seconds (healthy elderly, independent and without risk of falls); test between 11 and 20 seconds (frail elderly, with partial independence and low risk of falls); time greater than 20 seconds (significant deficit in physical capacity, high risk of falls and dependence in ADLs).
Walking speed
时间窗: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
Ten-meter walk test - The ten-meter walk test will be used to assess self-selected walking speed (VAS). The time taken to walk ten meters will be recorded. The individual will be given the following command: "I want you to walk at a comfortable speed, the one that is most similar to your daily pace. The average time of three attempts will be used to calculate the walking speed expressed in meters per second (m/s).
次要结局
- Concern about falls(Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).)
- Pain index(Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).)
- Depressive symptoms(Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).)
- Cognition(Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).)
研究者
Andrea Kruger Goncalves
Doctor
Federal University of Rio Grande do Sul