Feasibility BFRT Geriatric Stroke Patients

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Stroke

Treatments: Other: Blood flow restriction training; Other: Opinions

Study type: Interventional

Funder types: Other

Identifiers

NCT06398041

S68664

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Patients

Experimental group

Description:

Patients will undergo 8x a BFRT session and will be asked about their feelings and thoughts using a VAS an 7 points Likert Scale

Treatment:

Other: Opinions

Other: Blood flow restriction training

Physiotherapists

Other group

Description:

Physiotherapists involved in the practical application of BFRT will be asked about their thoughts using a 7 point Likert Scale

Treatment:

Other: Opinions