Viewing Study NCT06398041



Ignite Creation Date: 2024-05-06 @ 8:28 PM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06398041
Status: RECRUITING
Last Update Posted: 2024-06-26
First Post: 2024-04-18

Brief Title: Feasibility BFRT Geriatric Stroke Patients
Sponsor: Universitaire Ziekenhuizen KU Leuven
Organization: Universitaire Ziekenhuizen KU Leuven

Study Overview

Official Title: Feasibility of Blood Flow Restriction Training in Stroke Patients on a Geriatric Ward
Status: RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None