---
title: Feasibility BFRT Geriatric Stroke Patients
nct_id: NCT06398041
overall_status: UNKNOWN
phase: NA
sponsor: Universitaire Ziekenhuizen KU Leuven
study_type: INTERVENTIONAL
primary_condition: Stroke
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06398041.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06398041"
ct_last_update_post_date: 2024-06-26
last_seen_at: "2026-05-12T06:20:47.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Feasibility BFRT Geriatric Stroke Patients

**Official Title:** Feasibility of Blood Flow Restriction Training in Stroke Patients on a Geriatric Ward

**NCT ID:** [NCT06398041](https://clinicaltrials.gov/study/NCT06398041)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 16
- **Lead Sponsor:** Universitaire Ziekenhuizen KU Leuven
- **Collaborators:** KU Leuven
- **Conditions:** Stroke
- **Start Date:** 2024-05-01
- **Completion Date:** 2025-10-01
- **CT.gov Last Update:** 2024-06-26

## 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

- **Minimum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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
- **Physiotherapists** (OTHER) — Physiotherapists involved in the practical application of BFRT will be asked about their thoughts using a 7 point Likert Scale

## Interventions

- **Blood flow restriction training** (OTHER) — standard physiotherapy 45 minutes per day, 5 day a week (GAPP) + 2 extra sessions of blood flow restriction training
- **Opinions** (OTHER) — Healthcare workers in the geriatric rehabilitation ward and patients will be asked on their opinions on GAPP+Care concerning blood flow restriction training

## Primary Outcomes

- **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

## 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))_

## Locations (1)

- Universitaire Ziekenhuizen Leuven, campus Pellenberg, Pellenberg, Belgium — _RECRUITING_

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.universitaire ziekenhuizen leuven, campus pellenberg|pellenberg||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06398041.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06398041*  
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