Feasibility BFRT Geriatric Stroke Patients

NCT06398041 | Recruiting

• 1 other identifier: S68664
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Geriatric patients; Geriatric rehabilitation; Blood Flow Restriction Training; Physiotherapy; Strength training; stroke

Outcome Measures

Primary Outcomes (7)

• Proportion of eligible individuals and their willingness to undergo BFRT

  Number of available patients on the ward and number of eligible patients and number of patients who participate

  1 year

• Prevalence and types of Adverse events

  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

  1 year

• Rate of attended sessions over the total number of sessions planned

  attended sessions over the total number of sessions planned

  During a time frame of 1 year, this will be calculated during 4weeks/subject

• Visual Analog Scale for feelings of perceived pain, effort, safety and comfort

  Feelings of perceived pain, effort, safety and comfort will be scored after every trainingssession with a visual analog scale

  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)

• Time investment

  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)

  4 weeks/subject

• Feasibility assessed by the physiotherapist

  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

  1 year

• Feasibility assessed by the patients

  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

  During a time frame of 1 year, this will be calculated during 4weeks/subject

Secondary Outcomes (5)

• Muscle Strength 1

  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

  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

  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

  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

  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)

Study Arms (2)

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

Other: Blood flow restriction training; Other: Opinions

Physiotherapists

OTHER

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

Other: Opinions

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

Patients

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

Patients; Physiotherapists

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• being physiotherapist involved in the practical application of BFRT
• signed informed consent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

Universitaire Ziekenhuizen Leuven, campus Pellenberg

Pellenberg, 3212, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jos Tournoy, MD

  KU UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stef Gillabel, Msc

CONTACT

+3216344760; stef.gillabel@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional study with the aim to asses the feasibility of this intervention

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: May 3, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: October 1, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-03

Locations

BE (1)