Effect of Multi-component Exercise Intervention Program on the Degree of Frailty in Hospitalized Patients After Venous Hemolysis in Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Short Physical Performance Battery（SPPB）
研究概览
简要总结
Physical exercise is an effective strategy to maintain functional ability and improve debilitating symptoms in the elderly.In addition to functional enhancement, exercise is considered a cornerstone for enhancing cognitive function in debilitated older adults with cognitive impairment and dementia.The investigators evaluated the effect of the Vivifrail exercise intervention on the degree of debilitation in elderly hospitalized patients after venous hemolysis in acute ischemic stroke
详细描述
Elderly patients who are acutely hospitalized, including those who are able to walk independently, spend most of their stay in bed.In addition to worsening their functional status leading to significant muscle wasting and the development of other symptoms, it also increases the risk of cognitive decline and dementia in older adults, which is more pronounced in patients with acute ischemic stroke after venous hemolysis, and increases awareness of the need to replace prolonged bed rest with physical activity or exercise.Because there is evidence that this therapy during hospitalization is effective;A large number of studies have shown that rehabilitation training for AIS patients within 24 hours of onset is beneficial food.
In addition, exercise can reduce the damage caused by acute illness and hospitalization.Even so, it has not been established whether exercise therapy affects the degree of weakness or whether weakness affects response to treatment.
While frailty is not a disease, it can affect the presentation of many age-related diseases and the response to treatment.For example, after a short period of strength exercise in frail elderly people, autophagy in muscle cells is activated, affecting the overall health of the muscles and thus the ability to move.Similarly, the inflammatory response increases after vigorous aerobic exercise.It was also less clear whether individuals with higher frailty had any response to the intervention.
Multi-Component Exercise（Vivifrail） is an innovative multi-component exercise program that includes strength training, endurance training, balance training, and flexibility training to improve the exerciser's gait, balance, and cardiorespiratory function by increasing muscle mass, strength, and endurance.Recent studies have shown that it is one of the best ways to improve patients' gait, balance, cardiopulmonary function and cognitive executive function, as well as the best way to treat frailty, and can reduce the risk of falls and delay cognitive decline in elderly hospitalized patients with neurocognitive disorders.
The objective of this study was to examine the effect of exercise intervention on the level of frailty in older adults admitted for venous hemolysis for acute ischemic stroke.The effects of baseline frailty levels on the intervention, effectiveness of frailty, changes in Physical function (Modified Barthel Index (MBI), Short Physical Performance Battery (SPPB), and other health outcomes were determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Over 65 years of age;
- •Hospitalized patients diagnosed with ischemic stroke;
- •barthel index ≥60;
- •Muscle strength of both upper and lower limbs is above grade 3;
- •The pre-frailty and frailty state of the modified 5 Frailty Index (mFI-5) standard;
- •Patients willing to cooperate and sign informed consent
排除标准
- •fracture (within three months),
- •severe cognitive impairment, or severe dementia;
- •unable or unwilling to cooperate, any other unstable medical condition, or conditions that would prevent physical activity
研究组 & 干预措施
Routine exercise group
The routine exercise care group, that is, the control group, will complete the routine exercise care of patients with acute ischemic stroke after venous hemolytic surgery in accordance with the hospital regulations: From 24 hours after surgery, patients with mild and moderate stroke can be turned over in bed (once every 2 hours), ankle pump exercise (three times a day), and transitional bedside rehabilitation exercise (such as walking around the bed, etc.) after no discomfort.
Multicomponent exercise group
Select the corresponding intervention according to the SPPB score:0-3 scores (Plan A) :1. Walking 2.Relax your hand 3.Lift a bottle 4.Leg extensions with an ankle weight 5.Getting up from a chair with help 6.Holding onto the person who helps you 7.Arm stretching 4-6 scores(Plan B):1. Walking 2.Lift a bottle 3.Squeeze a ball 4.pretend to sit 5.Walking on tip toes and heels 6.Arm stretching in a chair 7.Stretch your arms up with your hands clasped;7-9 scores(Plan C):1.Walking 2.Roll-up a small towel 3.Take two plastic bottles filled with 500ml of water 4.Getting up from a chair 5.Walking over obstacles 6.Walking in a figure of eight 7.Leg stretching sit in a chair 8.Arm stretching;10-12 scores( Plan D):1.Walking 2.Twist a towel 3.Lift a bottle 4.Getting up from a chair 5.Going up and down stairs 6.Walking in a figure of eight 7.Walking while touching a balloon 8.Arm stretching;See details at http://vivifrail.com/
干预措施: Multi-component Exercise Intervention Program (Behavioral)
结局指标
主要结局
Short Physical Performance Battery（SPPB）
时间窗: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
The SPPB test to determine the level of frailty is a composite of the following three separate measures: 1. \- Balance test. 2. \- Walking speed test over 4 meters. 3. \- Test of getting up from a chair. Add the points of the SPPB test (1 to 3) to determine the grade. * If due to limitations, you have not performed the SPPB test and you have elected to use the 6-meter walking test, the following values will be used to recommend the physical exercise program. Points 0-3 scores are considered as disability and given program A intervention; A score of 4-6 is considered as the early stage of asthenia and B intervention program is given; A score of 7-9 was considered as weak and C intervention program was given; A score of 10-12 is considered as healthy people and D intervention program is given
FRAIL Scale
时间窗: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
Including fatigue, can not go up a flight of stairs, can not walk 500 m, suffering from more than 5 diseases, body mass decline a total of 5 indicators, using two classification scoring method, a total of 5 points. 0 was classified as no frailty, 1-2 as pre-frailty, and ≥3 as frailty.
Grip
时间窗: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
Use electronic grip dynamometer (Model: EH101) Before measurement, the instrument was calibrated to 0, the grip distance was adjusted, the fingers were naturally placed in the grip groove position, the study subjects were seated in the end position, the arm extension did not exceed 30 degrees, the upper arm and the forearm were 90 degrees, and the hands were measured with the maximum strength, the measurement interval was about 1 minute, so that the measuring hand could have enough relaxation and rest. A total of three tests were conducted. Average the ultimate grip strength, accurate to 0.1kg.
Modified Barthel Index
时间窗: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
The assessment of the individual's daily living ability includes 10 items, including eating, decoration, bathing, etc. Each index is divided into 5 levels: complete dependence, greater dependence, medium dependence, lesser dependence, and independence. The higher the score, the better the independence of daily life, a total of 100 points
次要结局
- Patient Health Questionaire - 9 items，PHQ -9(This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.)
- HendrichⅡfall risk model,HFRM(Acute ischemic stroke was evaluated within 48h of intravenous thrombolysis up to 4 weeks.)