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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
standard physiotherapy 45 minutes per day, 5 day a week (GAPP) + 2 extra sessions of blood flow restriction training
Healthcare workers in the geriatric rehabilitation ward and patients will be asked on their opinions on GAPP+Care concerning blood flow restriction training
Universitaire Ziekenhuizen Leuven, campus Pellenberg
Pellenberg, Belgium
RECRUITINGProportion of eligible individuals and their willingness to undergo BFRT
Number of available patients on the ward and number of eligible patients and number of patients who participate
Time frame: 1 year
Prevalence and types of Adverse events
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
Time frame: 1 year
Rate of attended sessions over the total number of sessions planned
attended sessions over the total number of sessions planned
Time frame: During a time frame of 1 year, this will be calculated during 4weeks/subject
Visual Analog Scale for feelings of perceived pain, effort, safety and comfort
Feelings of perceived pain, effort, safety and comfort will be scored after every trainingssession with a visual analog scale
Time frame: 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)
Time investment
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)
Time frame: 4 weeks/subject
Feasibility assessed by the physiotherapist
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
Time frame: 1 year
Feasibility assessed by the patients
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
Time frame: During a time frame of 1 year, this will be calculated during 4weeks/subject
Muscle Strength 1
The Medical Research Council (MRC) Scale for Muscle Strength, scores ranging from 0 to 5, with higher scores mean a better outcome
Time frame: 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
Muscle strength using a handheld dynamometer (MicroFet2), with higher scores mean a better outcome
Time frame: 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)
Active ROM against gravity
the active ROM measured with goniometer, with higher scores mean a better outcome
Time frame: 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
Berg Balance Scale (BBS), scores ranging from 0 to 56, with higher scores mean a better outcome
Time frame: 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
10 Meter walking test (10MWT)
Time frame: 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)
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