Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function for Stroke-Related Sarcopenia

May 7, 2025 updated by: The Hong Kong Polytechnic University

Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function in Individuals With Stroke-Related Sarcopenia: A Randomized Controlled Trial

Effects of Blood Flow Restriction Walking on Muscle Strength and Physical Function in Chronic Stroke Patients with Sarcopenia: A Randomized, Sham-Controlled Trial Primary Objective: To evaluate the effects of BFR walking on muscle strength and physical function in chronic stroke patients with sarcopenia, compared to sham-BFR walking.

Secondary Objective: (1) To explore the potential impact of BFR walking on muscle mass and vascular function in chronic stroke patients with sarcopenia. (2) To assess the influence of BFR walking on quality of life in chronic stroke patients with sarcopenia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • 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 Contact

Study Locations

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with chronic stroke (≥6 months post-stroke)
  • Diagnosed with sarcopenia, based on AWGS 2019 criteria

Exclusion Criteria:

  • Stroke occurred within the past 6 months
  • Resting systolic blood pressure > 200 mmHg
  • Resting diastolic blood pressure > 100 mmHg
  • Presence of implanted electronic or metallic devices that interfere with blood flow restriction cuffs
  • Contraindication to bioelectrical impedance analysis (e.g., pacemaker, ICD)

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BFR Walking Group
Participants in this group will receive blood flow restriction (BFR) walking training. The pressure cuffs will be applied to the proximal thighs. Walking sessions will be conducted on a treadmill at 60% of the participant's maximum walking speed, 3 times per week for 6 weeks. The cuff pressure will begin at 50% of each participant's arterial occlusion pressure (AOP), determined via Doppler ultrasound, and progressively increased every two weeks to a maximum of 200 mmHg.
Procedure: Blood Flow Restriction (BFR) Walking
Participants in this group will undergo a supervised treadmill walking program with blood flow restriction (BFR) applied using BFR pressure cuffs. The cuffs are applied to the proximal thighs, and the training pressure starts at 50% of the participant's arterial occlusion pressure (AOP), increasing every two weeks up to 200 mmHg. Walking is performed at 60% of the maximum walking speed, 20 minutes per session, 3 sessions per week for 6 weeks.
Sham Comparator: Sham-BFR Walking Group
Participants in this group will receive sham blood flow restriction walking training. Pressure cuffs will be applied to the proximal thighs but only inflated to 20 mmHg, which does not restrict blood flow. Walking sessions will be performed under the same treadmill conditions as the BFR group (60% of maximum walking speed, 3 sessions per week for 6 weeks).
Procedure: Sham Blood Flow Restriction (Sham-BFR) Walking
Participants in this group will follow the same supervised treadmill walking protocol as the BFR group but with minimal cuff pressure (20 mmHg), which does not restrict blood flow. This simulates the sensation of BFR without physiological impact. The purpose is to serve as a placebo comparator. Walking is performed at 60% of maximum walking speed, 20 minutes per session, 3 sessions per week for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Strength
Time Frame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Isometric peak torque of the target muscle groups will be measured during both extension and flexion using an isokinetic dynamometer. The unit of measurement is Newton-meters (Nm). Higher values indicate greater muscle strength.
baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Motor Function - Fugl-Meyer Assessment (FMA)
Time Frame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Motor function will be assessed using the Fugl-Meyer Assessment, a validated and widely used scale to evaluate motor recovery, particularly in individuals with neurological impairments such as stroke. The total score ranges from 0 to 226, with higher scores indicating better motor function. The assessment includes subscales for upper extremity, lower extremity, coordination, and reflex activity.
baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Aerobic Capacity and Endurance - Six-Minute Walk Test (6MWT)
Time Frame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Aerobic capacity and walking endurance will be measured using the Six-Minute Walk Test. Participants will be instructed to walk as far as possible in six minutes on a flat, straight surface. The total distance walked will be recorded in meters. This test reflects submaximal functional capacity relevant to daily physical activity.
baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Mobility - Timed Up and Go Test (TUG)
Time Frame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Functional mobility will be assessed using the Timed Up and Go Test. Participants will be asked to stand up from a chair, walk 3 meters, turn around, return to the chair, and sit down. The total time taken to complete the task will be recorded in seconds. Shorter times reflect better mobility.
baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Gait Speed - 10-Meter Walk Test (10MWT)
Time Frame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Gait speed will be assessed using the 10-Meter Walk Test at maximum safe walking speed. Participants will be instructed to walk a total of 10 meters as fast as safely possible. The time taken to walk the middle 6 meters (excluding acceleration and deceleration zones) will be recorded, and gait speed will be calculated in meters per second (m/s). Higher values indicate better fast walking ability.
baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Five Times Sit-to-Stand Test (FTSTS)
Time Frame: Baseline, Week 6, Week 12
The Five Times Sit-to-Stand Test measures the time in seconds (s) required for a participant to rise from a standard chair to a full standing position and return to sitting five times consecutively as quickly as possible, with arms crossed over the chest. A stopwatch will be used. Lower times indicate better lower limb function and power.
Baseline, Week 6, Week 12
Handgrip Strength
Time Frame: Baseline, Week 6, Week 12
Handgrip strength will be measured in kilograms (kg) using a digital hand dynamometer.
Baseline, Week 6, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional Status - Mini Nutritional Assessment Short Form (MNA-SF)
Time Frame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Nutritional status will be evaluated using the Mini Nutritional Assessment - Short Form (MNA-SF), a validated screening tool for identifying malnutrition or risk of malnutrition in older adults. The total score ranges from 0 to 14. Scores ≥12 indicate normal nutritional status, 8-11 at risk, and ≤7 malnourished.
baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Quality of Life - Sarcopenia and Quality of Life Questionnaire (SarQoL)
Time Frame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Quality of life related to sarcopenia will be assessed using the Sarcopenia and Quality of Life Questionnaire (SarQoL), a disease-specific instrument for older adults with reduced muscle mass or function. It covers domains such as physical health, mental health, locomotion, and daily activities. Higher scores indicate better quality of life.
baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Appendicular Skeletal Muscle Mass (ASM)
Time Frame: Baseline, Week 6, Week 12
ASM will be assessed using bioelectrical impedance analysis (BIA) and reported in kilograms per square meter (kg/m²). This value is calculated as total limb lean mass divided by height squared, following the AWGS 2019 criteria.
Baseline, Week 6, Week 12
Muscle Thickness (MT)
Time Frame: Baseline, Week 6, Week 12
Muscle thickness will be measured using B-mode ultrasonography with a high-frequency linear probe. Values will be reported in millimeters (mm). The average of three measurements will be used for each muscle. Muscle Thickness of Rectus Femoris and Medial Gastrocnemius.
Baseline, Week 6, Week 12
Pennation Angle
Time Frame: Baseline, Week 6, Week 12
Pennation angle will be obtained from ultrasound images using ImageJ software. The angle between the muscle fascicles and deep aponeurosis will be measured in degrees (°).
Baseline, Week 6, Week 12
Cross-Sectional Area (CSA)
Time Frame: Baseline, Week 6, Week 12
CSA will be measured from transverse ultrasound images and reported in square centimeters (cm²). Measurements will be taken at standardized anatomical landmarks.
Baseline, Week 6, Week 12
Echo Intensity (EI)
Time Frame: Baseline, Week 6, Week 12
Echo intensity will be calculated using grayscale analysis from ultrasound images and reported in arbitrary units (a.u.), based on pixel brightness (0 = black, 255 = white).
Baseline, Week 6, Week 12

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

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 (Estimated)

May 15, 2025

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

December 28, 2027

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20250109003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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