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

Effects of Blood Flow Restricted High Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors: A Pilot Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke, Ischemic; Chronic Stroke; Ambulation Disorder, Neurologic
• Intervention / Treatment: Other: Blood Flow Restricted High Intensity Treadmill Training; Other: HITT

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar National Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Cohort; 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; 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.; Other Names: BFR-HITT
Active Comparator: Control Cohort; High-Intensity Treadmill Training 2x weekly for 16 Sessions totaling a minimum of 75minutes weekly.	Other: HITT; High Intensity Treadmill Training 2x weekly for 16 Sessions totaling minimum of 75minutes weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 Meter Walk Test	The 10MWT assesses walking speed in meters per second over a short duration.	Baseline, Week 4 (up to one week), Week 8( up to one week)
5 Time Sit to Stand	The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements.	Baseline, Week 4 (up to one week), Week 8( up to one week)
Functional Gait Assessment	The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. The tool is a modification of the 8-item Dynamic Gait Index, developed to improve reliability and reduce ceiling effect. Each item is scored on an ordinal scale from 0 to 3, with 0 = severe impairment, 1 = moderate impairment, 2 = mild impairment, 3 = normal ambulation. The highest score = 30 indicating no impairment in postural stability during walking.	Baseline, Week 4 (up to one week), Week 8( up to one week)
BERG Balance Scale	The Berg Balance Scale (BBS) is a 14-item objective measure that assesses static balance and fall risk in adults. Item-level scores range from 0-4 and are determined by ability to perform the assessed activity Item scores are then summed with lower scores indicating higher fall risk. The maximum score = 56.	Baseline, Week 4 (up to one week), Week 8( up to one week)
Activities Balance Confidence Scale-16	The ABC Scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Items are rated on a rating scale that ranges from 0 - 100. Score of zero represents no confidence, a score of 100 represents complete confidence. Overall score is calculated by adding item scores and then dividing by the total number of items.	Baseline, Week 4 (up to one week), Week 8( up to one week)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower Extremity Limb Circumference	Limb circumference (cm) of hemiparetic lower extremity and unaffected lower extremity will be taken to determine if limb hypertrophy has occurred.	Baseline, Week 4 (up to one week), Week 8( up to one week)
1 Repetition Maximum Strength Testing (Leg press)	1 Repetition Maximum Strength Testing (Leg press) is a measure of overall hemiparetic gross push strength and is measured as the greatest force (in lbs) a patient can push with hemiparetic lower extremity one time.	Baseline, Week 4 (up to one week), Week 8( up to one week)
1 Repetition Maximum Strength Testing (Knee Extension)	1 Repetition Maximum Strength Testing (Knee Extension) is a measure of isolated hemiparetic quadriceps strength and is measured as the greatest force (in lbs) a patient can extend their hemiparetic quadriceps one time.	Baseline, Week 4 (up to one week), Week 8( up to one week)

Collaborators and Investigators

• Sponsor: MedStar National Rehabilitation Network

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: BFR; Blood Flow Restriction Training; BFRt; High Intensity Treadmill Training
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Stroke; Ischemic Stroke; Ischemia; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: BFR-HITT

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