Feasibility BFRT Geriatric Stroke Patients

NCT ID: NCT06398041

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-10-01

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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients

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

Group Type: EXPERIMENTAL

Blood flow restriction training

Intervention Type: OTHER

standard physiotherapy 45 minutes per day, 5 day a week (GAPP) + 2 extra sessions of blood flow restriction training

Opinions

Intervention Type: OTHER

Healthcare workers in the geriatric rehabilitation ward and patients will be asked on their opinions on GAPP+Care concerning blood flow restriction training

Physiotherapists

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

Group Type: OTHER

Opinions

Intervention Type: OTHER

Healthcare workers in the geriatric rehabilitation ward and patients will be asked on their opinions on GAPP+Care concerning blood flow restriction training

Interventions

Blood flow restriction training

standard physiotherapy 45 minutes per day, 5 day a week (GAPP) + 2 extra sessions of blood flow restriction training

Intervention Type: OTHER

Opinions

Healthcare workers in the geriatric rehabilitation ward and patients will be asked on their opinions on GAPP+Care concerning blood flow restriction training

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• being physiotherapist involved in the practical application of BFRT
• 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:

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jos Tournoy, MD

Role: PRINCIPAL_INVESTIGATOR

KU UZ Leuven

Locations

Universitaire Ziekenhuizen Leuven, campus Pellenberg

Pellenberg, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Stef Gillabel, Msc

Role: CONTACT

stef.gillabel@uzleuven.be

+3216344760

Facility Contacts

Stef Gillabel, Msc

Role: primary

stef.gillabel@uzleuven.be

003216344760

Jos Tournoy, MD

Role: backup

jos.tournoy@uzleuven.be

Other Identifiers

S68664

Identifier Type: -

Identifier Source: org_study_id