Blood Flow Restricted High-Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors

NCT06214494 | Enrolling By Invitation DMC

• 1 other identifier: BFR-HITT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals surviving Chronic Ischemic Stroke have lingering walking deficits long after their infarct. The main goal of this study is to compare two high intensity treadmill walking programs to see which improves walking more. The main question we aim to answer is: How does blood flow restricted high-intensity treadmill training impact walking function? Participants will be randomly separated into two groups. One group will perform the high intensity treadmill training with blood flow restriction on their Stroke affected leg, while the second group performs high intensity treadmill training only. Every week participants will be asked to walk on the treadmill for a total of 75 minutes during 2x 1-hour sessions. On visit 1, participants will undergo strength, balance, and walking testing. They will then be treated 2x weekly for 4 weeks (visit 2-9) and be re-tested to track progress on visit 10. Participants will again be treated 2x weekly for 4 more weeks (visit 11-18) and be tested to see the end results on visit 19. Researchers will then compare both groups to see if blood flow restriction training changes walking function, strength, and balance.

Conditions

Stroke, Ischemic; Ambulation Disorder, Neurologic; Chronic Stroke

Keywords

Blood Flow Restriction Training; BFR; BFRt; High Intensity Treadmill Training

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test

  The 6-minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.

  Baseline, Week 4 (up to one week), Week 8( up to one week)

Secondary Outcomes (5)

• 10 Meter Walk Test

  Baseline, Week 4 (up to one week), Week 8( up to one week)

• 5 Time Sit to Stand

  Baseline, Week 4 (up to one week), Week 8( up to one week)

• Functional Gait Assessment

  Baseline, Week 4 (up to one week), Week 8( up to one week)

• BERG Balance Scale

  Baseline, Week 4 (up to one week), Week 8( up to one week)

• Activities Balance Confidence Scale-16

  Baseline, Week 4 (up to one week), Week 8( up to one week)

Other Outcomes (3)

• Lower Extremity Limb Circumference

  Baseline, Week 4 (up to one week), Week 8( up to one week)

• 1 Repetition Maximum Strength Testing (Leg press)

  Baseline, Week 4 (up to one week), Week 8( up to one week)

• 1 Repetition Maximum Strength Testing (Knee Extension)

  Baseline, Week 4 (up to one week), Week 8( up to one week)

Study Arms (2)

Interventional Cohort

EXPERIMENTAL

Blood Flow Restricted High Intensity Treadmill Training at 70% limb occlusion 2x weekly for 16 Sessions totaling a minimum of 75 minutes weekly.

Other: Blood Flow Restricted High Intensity Treadmill Training

Control Cohort

ACTIVE COMPARATOR

High-Intensity Treadmill Training 2x weekly for 16 Sessions totaling a minimum of 75minutes weekly.

Other: HITT

Interventions

Blood Flow Restricted High Intensity Treadmill Training OTHER

Blood Flow Restricted High Intensity Treadmill Training at 70% limb occlusion (on hemiparetic limb only) 2x weekly for 16 Sessions totaling minimum of 75 minutes weekly.

Also known as: BFR-HITT

Interventional Cohort

HITT OTHER

High Intensity Treadmill Training 2x weekly for 16 Sessions totaling minimum of 75minutes weekly.

Control Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years or older with history of single ischemic stroke \>6months.
• Ambulate without physical assistance over 10M with or without mobility aides and bracing in 180 seconds or less.

You may not qualify if:

• Concurrent physical or occupational therapy.
• Vulnerable populations such as adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners will be excluded.
• Resting BP \>160/100mmHg even with medication.
• People who have taken analgesics, dopamine, antipyretics, and any other drugs that can affect the function of the autonomic nervous system in the last 2 weeks and likely to be treated with such drugs during the course of the study.
• Individuals who score 9 (greater than normal or minimal impairment) or more on the Short Blessed Cognitive Assessment (6 item) will be unable to give informed consent.
• Any medical condition (including heart failure, unstable angina, aortic stenosis, arrhythmias, hypertrophic cardiomyopathy, depression of ST-segment, previous or active deep vein thrombosis (DVT) in the hemiparetic lower extremity, pulmonary embolism (PE), bypass surgery within last 3 months.) that, in the opinion of the investigator, might jeopardize the participants' safety.

Sponsors & Collaborators

• MedStar National Rehabilitation Network: lead

Study Sites (1)

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Randomized Case Control Cohort Study

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 19, 2024
• Study Start: March 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: August 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)