Feasibility BFRT Geriatric Stroke Patients

Stroke Clinical Trial

Official title:

Feasibility of Blood Flow Restriction Training in Stroke Patients on a Geriatric Ward

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398041
• Other study ID #: S68664
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: March 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Stef Gillabel, Msc
• Phone: +3216344760
• Email: stef.gillabel[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: October 1, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

A. Patients

Inclusion Criteria patients:

• Patients admitted to the geriatric rehabilitation unit

• = 65years old

• Medically stable as determined by the attending physician

• Expecting at least 5 weeks of rehabilitation

• Diagnosis of stroke (haemorrhagic/ischemic)

• medical research council-scores of 2-3/5 for certain muscle groups

• Being able to understand the exercises

• signed informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Blood flow restriction training
standard physiotherapy 45 minutes per day, 5 day a week (GAPP) + 2 extra sessions of blood flow restriction training
• Opinions
Healthcare workers in the geriatric rehabilitation ward and patients will be asked on their opinions on GAPP+Care concerning blood flow restriction training

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven, campus Pellenberg	Pellenberg

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion 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	1 year
Primary	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	1 year
Primary	Rate of attended sessions over the total number of sessions planned	attended sessions over the total number of sessions planned	During a time frame of 1 year, this will be calculated during 4weeks/subject
Primary	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	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)
Primary	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)	4 weeks/subject
Primary	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	1 year
Primary	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	During a time frame of 1 year, this will be calculated during 4weeks/subject
Secondary	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	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)
Secondary	Muscle Strength 2	Muscle strength using a handheld dynamometer (MicroFet2), with higher scores mean a better outcome	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)
Secondary	Active ROM against gravity	the active ROM measured with goniometer, with higher scores mean a better outcome	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)
Secondary	Functional balance	Berg Balance Scale (BBS), scores ranging from 0 to 56, with higher scores mean a better outcome	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)
Secondary	Walking speed	10 Meter walking test (10MWT)	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)