StrokeNCT06398041
Feasibility BFRT Geriatric Stroke Patients
A study testing Blood flow restriction training and Opinions in people with Stroke, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Blood flow restriction training and Opinions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Being able to understand the exercises
- signed informed consent
- being physiotherapist involved in the practical application of BFRT
- signed informed consent
Who cannot join
- 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)
- Healthcare workers:
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuizen Leuven, campus Pellenberg
Pellenberg, 3212
Stef Gillabel, Msc, 003216344760, stef.gillabel@uzleuven.be
Jos Tournoy, MD, jos.tournoy@uzleuven.be
About this study
Official title: Feasibility of Blood Flow Restriction Training in Stroke Patients on a Geriatric Ward
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.
Read the detailed 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.
- Conditions
- Stroke
- Being tested
- Blood flow restriction training, Opinions
- Keywords
- Geriatric patients, Geriatric rehabilitation, Blood Flow Restriction Training, Physiotherapy, Strength training, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction trainingOther
standard physiotherapy 45 minutes per day, 5 day a week (GAPP) + 2 extra sessions of blood flow restriction training
OpinionsOther
Healthcare workers in the geriatric rehabilitation ward and patients will be asked on their opinions on GAPP+Care concerning blood flow restriction training
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients will undergo 8x a BFRT session and will be asked about their feelings and thoughts using a VAS an 7 points Likert Scale Receives: Other: Blood flow restriction training; Other: Opinions |
| Physiotherapists | Other | Physiotherapists involved in the practical application of BFRT will be asked about their thoughts using a 7 point Likert Scale Receives: Other: Opinions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 year
Rate of attended sessions over the total number of sessions planned
attended sessions over the total number of sessions planned
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: During a time frame of 1 year, this will be calculated during 4weeks/subject
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 May 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Interventional study with the aim to asses the feasibility of this intervention
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Jos Tournoy, MD, Principal investigator, KU UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398041
- Sponsor's protocol ID
- S68664
- Status last verified
- Mar 2024
- First submitted
- 18 Apr 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Blood Flow Restriction Training in Stroke Patients on a Geriatric Ward
- ClinicalTrials.gov ID
- NCT06398041
- Acronym / sponsor ID
- S68664
- Conditions
- Stroke
- Keywords
- Geriatric patients, Geriatric rehabilitation, Blood Flow Restriction Training, Physiotherapy, Strength training, stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional study with the aim to asses the feasibility of this intervention
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Blood flow restriction training, Other: OpinionsPatients will undergo 8x a BFRT session and will be asked about their feelings and thoughts using a VAS an 7 points Likert Scale |
| Physiotherapists | Other | Other: OpinionsPhysiotherapists involved in the practical application of BFRT will be asked about their thoughts using a 7 point Likert Scale |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
- Healthcare workers:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction trainingstandard physiotherapy 45 minutes per day, 5 day a week (GAPP) + 2 extra sessions of blood flow restriction training | Other | Patients |
| OpinionsHealthcare workers in the geriatric rehabilitation ward and patients will be asked on their opinions on GAPP+Care concerning blood flow restriction training | Other | Patients, Physiotherapists |
Primary outcome
Proportion of eligible individuals and their willingness to undergo BFRT
Time frame: 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
Time frame: 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
Time frame: During a time frame of 1 year, this will be calculated during 4weeks/subject
attended sessions over the total number of sessions planned
Visual Analog Scale for feelings of perceived pain, effort, safety and comfort
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)
Feelings of perceived pain, effort, safety and comfort will be scored after every trainingssession with a visual analog scale
Time investment
Time frame: 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 physiotherapist
Time frame: 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
Feasibility assessed by the patients
Time frame: 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
5 secondary outcomes
Muscle Strength 1
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
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
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
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jos Tournoy, MD principal investigator
KU UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction training and Opinions in people with Stroke, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stef Gillabel, Msc (+3216344760, stef.gillabel@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible individuals and their willingness to undergo BFRT (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.