The Effects of Blood Flow Restriction With Low-intensity Resistance Training Versus Traditional Resistance Exercise on Lower Limb Strength, Walking Capacity, and Balance in Patients With Ischemic Stroke: (BFR-Stroke RESILIENCE Trial)

March 20, 2022 updated by: Ishtiaq Ahmed, Istanbul University-Cerrahpasa
Stroke is the leading neurological disease in the world that causes long-term disability. The most common cause of disability after stroke is motor impairment resulting from brain damage which ultimately causes mobility and functional limitation. Worldwide, the incidence of stroke has been increased by 30% in the last decade. In Europe, more than one million cases have been reported each year and six million stroke survivors are known to be alive till now. The annual estimated cause of stroke treatment in Europe is twenty-seven billion Euros. By 2030, it is estimated that the cost of stroke treatment will be triple the current amount and can reach up to 184 billion dollars. Therefore, it is necessary to develop an economical rehabilitation program that prevents or reduces long-term disability after stroke.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Blood flow restriction combined with resistance training may be an economic and time-efficient alternative to High-Intensity Training to manage the risk factors of stroke and can also be useful in reducing stroke-related impairment effectively. During BFRT, the blood flow of the exercising muscle is restricted by placing the inflated tourniquets at the most proximal part of the legs or arms. By restricting the blood flow to the limbs, the desired muscle group will work in an ischemic environment and can trigger a significant increase in muscle mass, power, and strength by recruiting the fast-twitch muscle fibers. BFRT could be a promising type of exercise for high-risk groups of patients such as Cardiovascular disease, stroke, etc, and the hypertrophy responses induced by is comparable to that produced by high-intensity training. It was found that BFRT and high-intensity training produced similar effects on both systolic, diastolic blood pressure, and heart rate (HR) in young individuals and older adults. Previous evidence from neurological studies showed that resistance combined with blood flow restriction can improve muscle strength, balance, walking capacity, and cognitive function in Multiple Sclerosis and spinal cord injury patients. Recent study showed that BFR combined with resistance training has improved brain-derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF) and rate of perceived exertion in ischemic stroke patients. Kaatsu training society also reported a few cases in which BFRT has produced a positive effect on the recovery of stroke patients, but the evidence is insufficient to support this assertion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34160
        • Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All the participants will be evaluated to be in stable Cardio-vascular condition i,e ACSM Class B.
  • 18 to 90 years of age.
  • More than 1 month of stroke onset.
  • First ever unilateral ischemic stroke.
  • Being able to walk 10 m independently with or without an assistive device.
  • Being an independent ambulator (Functional Ambulation Scale>3).
  • Muscle tension of the modified Ashworth scale was lower than grade.

Exclusion Criteria

  • People with a history of mental illness.
  • People with obvious cognitive impairments.
  • Combination with peripheral neuropathy.
  • Having resting blood pressure above 160/100 mmHg even after taking medications.
  • Hemorrhagic stroke
  • Cardiovascular comorbidity (aortic stenosis, depression of ST-segment, heart failure, arrhythmias, unstable angina, hypertrophic cardiomyopathy).
  • Transient ischemic attack.
  • By-pass surgery in the recent three months
  • Any 0ther musculoskeletal problems that prevented the participants from doing resistance training
  • People who have taken antipyretics, analgesics, dopamine, and other drugs that affect autonomic nerve function within 2 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-intensity resistance exercise with blood flow restriction group (L-BFR).
All the participants in the low-intensity resistance exercise with blood flow restriction group (L-BFR) will receive 3 sessions of low-intensity resistance training with blood flow restriction for a total of 5 weeks.
Other: Low-intensity resistance exercise with blood flow restriction group (L-BFR)
The blood flow restriction training group will perform 3 sets of Sandbag (SB) resistance exercises, targeting the large muscles of the legs, at 40% of 1-RM. The SB protocol consists of 3 sets of 4 SB exercises. Each set consists of 10 repetitions of 1-RM with a 1-min recovery interval between sets and 3-min between exercises. Blood flow to the active muscle during training will be restricted by a blood flow restriction band (tourniquet) placed at the proximal end of the lower limbs. When the subjects performed training with BFR, the proximal portions of their lower limbs will be compressed at the pressure of 120-160 mmHg by electronically controlled air pressure belts. The air pressure belt will be inflated before the exercise and will remain inflated during one-minute intervals between the sets and will be deflated during the three-minute interval between the exercise.
Active Comparator: High-intensity resistance exercise without blood flow restriction group (H-BFR).
All the participants in the high-intensity resistance exercise without blood flow restriction group (H-BFR) will receive 3 sessions of high-intensity resistance training without blood flow restriction for a total of 5 weeks.
Other: High-intensity resistance exercise without blood flow restriction group (H-BFR).
The high-intensity restriction training group will perform 3 sets of Sandbag (SB) resistance exercises, targeting the large muscles of the legs, at 80% of 1-RM. The SB protocol consist of 3 sets of 4 SB exercises. Each set consists of 10 repetitions of 1-RM with a 1-min rest interval between sets and 3-min between exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change score of Sit to stand Test
Time Frame: Baseline, Post-intervention (Approximately 5 weeks), follow-up (up to 3 Months)
Five time sit to stand test will be used to assess lower extremity muscle strength, balance and risk of fall in stroke patients. The test measure amount of time taken to complete five repetitions of sit to stand task. The test will be performed with standard height chair without an armrest and with straight back (43-45 cm high). He patients will be instructed to stand up and sit down as quickly as possible 5 times, keeping their arms folded across their chest. Timing began when the patient's back left the backrest and stopped once the back touched the backrest for the fifth time.
Baseline, Post-intervention (Approximately 5 weeks), follow-up (up to 3 Months)
Change score of 10 Meter walk Test
Time Frame: Baseline, Post-intervention (Approximately 5 weeks)
The Comfortable 10-m Walk Test (10 MWT) will be used to determine the speed of comfortable walking. The test will be applied in a 14-m corridor. The patients will be instructed to walk comfortably and allowed to use walking aid. At the 2nd meter, the stopwatch will be started and stopped when the patient reached the 12th meter. Walking time and number of steps will be assessed to calculate gait speed (m/s), stride length (m), and cadence (steps/min). After three trials, the average of the three trials will be recorded as m/s.
Baseline, Post-intervention (Approximately 5 weeks)
Change score of Timed up and Go Test (TUG)
Time Frame: Baseline, Post-intervention (Approximately 5 weeks)
The Timed Up & Go test is a functional mobility test used to assess dynamic balance, transfer, and gait. The patient is instructed to stand up from a chair (46 cm high) with support for the arms, walk for a short distance (3 m), turn, go back and sit down as quickly as possible. The stopwatch will be used to measure the time to perform these tasks from start to end. The patients will be allowed to use their walking aids. After three trials, the average of the three trials will be recorded.
Baseline, Post-intervention (Approximately 5 weeks)
Change score of 6 Minute walk Test
Time Frame: Baseline, Post-intervention (Approximately 5 weeks)
The walking distance will be measured by the 6 Minute walk Test (6MWT), the most commonly used for measuring the physical performance of individuals after stroke. The patients will be asked to walk as far as possible throughout the 30-meter course within 6 minutes by following the standardized instructions provided by the physiotherapist. Participants will be allowed by the physiotherapist to use aiding device if necessary. Physiotherapist will guard the participants during the walk test but will not offer any assistance or support to the participant.
Baseline, Post-intervention (Approximately 5 weeks)
Change score of Barthel Index
Time Frame: Baseline, Post-intervention (Approximately 5 weeks)
The Barthel Index measures a person's performance in activities of daily living. The Barthel Index consists of 10 items of mobility and self care activities of daily living. This score will be measured on admission and at the end of intervention (at the end of 5th week). The minimum score is 0 and the maximum is 100. A higher score indicates a better outcome.
Baseline, Post-intervention (Approximately 5 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change score of Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, Post-intervention (Approximately 5 weeks)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
Baseline, Post-intervention (Approximately 5 weeks)
Attendance
Time Frame: Number of sessions attended will be measured during the 5 weeks of intervention protocol.
Attendance of training sessions measured via Hospital entry sheet.
Number of sessions attended will be measured during the 5 weeks of intervention protocol.
Adverse Events
Time Frame: Any adverse event reported during the 5 weeks of intervention protocol.
Any adverse event or near miss is required to be reported.
Any adverse event reported during the 5 weeks of intervention protocol.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University-Cerrahpasa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Rustem Mustafaoglu, PhD, Istanbul University-Cerrahpaşa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-13022260-199-207631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings