Clinical trial NCT06398041: Feasibility BFRT Geriatric Stroke Patients
Official title: Feasibility of Blood Flow Restriction Training in Stroke Patients on a Geriatric Ward
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Geriatric patients
Geriatric rehabilitation
Blood Flow Restriction Training
Physiotherapy
Strength training
stroke
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2024-05-03
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Interventional study with the aim to asses the feasibility of this intervention
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of eligible individuals and their willingness to undergo BFRT
timeFrame: 1 year
measure: Prevalence and types of Adverse events
timeFrame: 1 year
measure: Rate of attended sessions over the total number of sessions planned
timeFrame: During a time frame of 1 year, this will be calculated during 4weeks/subject
measure: Visual Analog Scale for feelings of perceived pain, effort, safety and comfort
timeFrame: 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)
measure: Time investment
timeFrame: 4 weeks/subject
measure: Feasibility assessed by the physiotherapist
timeFrame: 1 year
measure: Feasibility assessed by the patients
timeFrame: During a time frame of 1 year, this will be calculated during 4weeks/subject
Secondary outcomes:
measure: Muscle Strength 1
timeFrame: 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)
measure: Muscle Strength 2
timeFrame: 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)
measure: Active ROM against gravity
timeFrame: 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)
measure: Functional balance
timeFrame: 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)
measure: Walking speed
timeFrame: 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)
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: Universitaire Ziekenhuizen Leuven, campus Pellenberg
Study officials:
affiliation: KU UZ Leuven
name: Jos Tournoy, MD
role: PRINCIPAL_INVESTIGATOR
References: