Feasibility of Blood Flow Restriction Training in Stroke Patients on a Geriatric Ward
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Feasibility assessed by the physiotherapist
研究概览
简要总结
The focus of this interventional study is to assess the feasibility of blood flow restriction training (BFRT) in a geriatric stroke population. Patients will undergo a 4-week program of BFRT additionally to our standard physiotherapy, conducted twice weekly by experienced physiotherapists.
The main goal of the study is to assess its feasibility concerning the safety and tolerance of BFRT from a patients and therapists scope. Furthermore, the investigators want to establish the proportion of eligible individuals & their willingness to undergo BFRT, as well as the time investment.
The feasibility of an effectiveness study and potential sample size will be evaluated aside.
详细描述
Stroke is often linked to a loss in muscle strength and a decline in functioning during daily life. In the past, several studies have focused on the effects of resistance training on muscle strength in order to restore patients functioning in daily life. For optimal improvements in muscle strength, the use of high loads with few repetitions per set have been recommended, even within the geriatric population. However, the use of high load exercises in a geriatric population can often be challenging, particularly in patients who have suffered a stroke.
To counter this, blood flow restriction training (BFRT) might give some opportunities. BFRT is a relatively new technique for strength training using a cuff to compromise blood flow in combination with low loads. It is a Japanese technique from origin also known as KAATSU and has been proven to be effective in several populations, including a geriatric population.
During this study, patients will undergo 8 sessions of BFRT given by experienced physiotherapists, twice a week during a 4-week program additionally to standard physiotherapy program: the Geriatric Activation Program Pellenberg (GAPP). Each patient will undergo 1 or 2 specific predetermined exercises for the upper or lower limb, based on the individual goals.
The main goal of the study is to assess its feasibility concerning the safety and tolerance of BFRT from a patients and therapists scope. Furthermore, the investigators want to establish the proportion of eligible individuals & their willingness to undergo BFRT, as well as the time investment.
The feasibility of an effectiveness study and potential sample size will be evaluated aside.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Skin lesions located at the site of the cuff
- •Cognitive impairment making it impossible to understand the exercises
- •Severe comorbidities: (Deep Venous Thrombosis; Open wounds or infected wounds; Dialysis; Cancer; Severe High Blood pressure)
- •B. Healthcare workers:
- •Inclusion Criteria
- •being physiotherapist involved in the practical application of BFRT
- •signed informed consent
结局指标
主要结局
Feasibility assessed by the physiotherapist
时间窗: 1 year
Feasibility assessed by the physiotherapist using a 7point Likert Scale for an agreement with several statements and will include options: strongly disagree, disagree, somewhat disagree, either agree or disagree, somewhat agree, and agree
Proportion of eligible individuals and their willingness to undergo BFRT
时间窗: 1 year
Number of available patients on the ward and number of eligible patients and number of patients who participate
Prevalence and types of Adverse events
时间窗: 1 year
During the entire time frame of the study, all adverse events will be collected and sorted into different categories. Furthermore, the prevalence of this types will be calculated
Rate of attended sessions over the total number of sessions planned
时间窗: During a time frame of 1 year, this will be calculated during 4weeks/subject
attended sessions over the total number of sessions planned
Time investment
时间窗: 4 weeks/subject
the time needed to execute the exercises will be divided by the total time (time to prepare the patient, calibrate the cuff pressure and execute the exercises)
Feasibility assessed by the patients
时间窗: During a time frame of 1 year, this will be calculated during 4weeks/subject
Feasibility assessed by the patients using a 7point Likert Scale for an agreement with several statements and will include options: strongly disagree, disagree, somewhat disagree, either agree or disagree, somewhat agree, and agree
Visual Analog Scale for feelings of perceived pain, effort, safety and comfort
时间窗: During a time frame of 1 year, each subject will be asked to complete a VAS-scale after every trainingssession (8x/subject over a period of 4 weeks)
Feelings of perceived pain, effort, safety and comfort will be scored after every trainingssession with a visual analog scale
次要结局
- Active ROM against gravity(During a time frame of 1 year, each subject will tested at baseline and the day following the last training session (to counteract fatigue) (2 times over 5 weeks/subject))
- Muscle Strength 1(During a time frame of 1 year, each subject will tested at baseline and the day following the last training session (to counteract fatigue) (2 times over 5 weeks/subject))
- Muscle Strength 2(During a time frame of 1 year, each subject will tested at baseline and the day following the last training session (to counteract fatigue) (2 times over 5 weeks/subject))
- Functional balance(During a time frame of 1 year, each subject will tested at baseline and the day following the last training session (to counteract fatigue) (2 times over 5 weeks/subject))
- Walking speed(During a time frame of 1 year, each subject will tested at baseline and the day following the last training session (to counteract fatigue) (2 times over 5 weeks/subject))