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

Effects of Blood Flow Restriction Training on Physical Performance 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: Recruiting
• Conditions: Sarcopenia; Chronic Stroke Patients
• Intervention / Treatment: Procedure: Blood Flow Restriction (BFR) Walking; Procedure: Sham Blood Flow Restriction (Sham-BFR) Walking

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingxiu Diao, Master; Phone Number: +8614796733917; Email: 24039355r@connect.polyu.hk

Study Locations

• Hong Kong
  • Kowloon
    • Hung Hom, Kowloon, Hong Kong, 999077
      • Not yet recruiting
      • Hong Kong Polytechnic University
      • Contact: Yingxiu Diao, Master; Phone Number: 8614796733917; Email: 24039355r@connect.polyu.hk
      • Contact: Yarou Yuan, Master; Phone Number: 90495235; Email: sabrina.yuan@connect.polyu.hk
      • Sub-Investigator: Yingxiu Diao, Master
    • Hung Hom, Kowloon, Hong Kong, 999077
      • Recruiting
      • Hong Kong Polytechnic University
      • Sub-Investigator: Yingxiu Diao, Master
      • Contact: Jingquan Cai, Master; Phone Number: +85294149862; Email: kingston.cai@polyu.edu.hk
      • Principal Investigator: Marco Pang, PhD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosed with chronic stroke (≥6 months post-stroke)
• Sarcopenia will be diagnosed using the Asian Working Group for Sarcopenia (AWGS) 2025 criteria, defined as the concurrent presence of low muscle strength and low appendicular skeletal muscle mass. Muscle strength will be assessed using handgrip strength measured on the non-paretic side. Low muscle strength will be defined as handgrip strength <28 kg for men and <18 kg for women aged ≥65 years, and <34 kg for men and <20 kg for women aged 50-64 years. Appendicular skeletal muscle mass will be measured using bioelectrical impedance analysis, and the appendicular skeletal muscle mass index will be calculated as appendicular skeletal muscle mass divided by height squared. Low muscle mass will be defined as an appendicular skeletal muscle mass index <7.0 kg/m² for men and <5.7 kg/m² for women aged ≥65 years, and <7.6 kg/m² for men and <5.7 kg/m² for women aged 50-64 years.

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Experimental: BFR Walking Group; Participants in this group will receive blood flow restriction (BFR) walking training. Pneumatic cuffs will be applied proximally to both thighs. Walking sessions will be conducted on a treadmill at 60% of each participant's maximal gait speed for 20 minutes per session, 3 sessions per week, for 6 weeks. Cuff pressure will be progressively increased from 140 mmHg in Week 1 to a maximum of 200 mmHg in Week 6, according to individual tolerance. Vital signs and symptoms will be monitored throughout each session.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength	Isometric knee extensor strength of the paretic limb will be assessed using an isokinetic dynamometer at 60 degrees of knee flexion. The primary variable will be peak torque, recorded in Newton-meters (N·m). Higher values indicate greater knee extensor strength.	baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Status - Mini Nutritional Assessment Short Form (MNA-SF)	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)	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)	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)	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
Six-Minute Walk Distance	Walking endurance will be assessed using the 6-Minute Walk Test. Participants will be instructed to walk as far as possible along a level indoor walkway within 6 minutes. The total distance covered will be recorded in meters. Higher values indicate better walking endurance.	Baseline, Week 6, and Week 12
Berg Balance Scale	Balance ability will be assessed using the Berg Balance Scale, which includes 14 functional balance tasks. Each item is scored from 0 to 4, with a total score ranging from 0 to 56. Higher scores indicate better balance performance.	Baseline, Week 6, and Week 12
Timed Up and Go Test	Functional mobility will be assessed using the Timed Up and Go Test. Participants will rise from a chair, walk 3 meters, turn around, walk back, and sit down. The time required to complete the task will be recorded in seconds. Lower values indicate better functional mobility.	Baseline, Week 6, and Week 12
Five-Times Sit-to-Stand Test	Lower-limb functional strength will be assessed using the Five-Times Sit-to-Stand Test. Participants will be instructed to stand up from a standard chair and sit down five times as quickly as possible without using their arms. The time required to complete the test will be recorded in seconds. Lower values indicate better lower-limb functional performance.	Baseline, Week 6, and Week 12
Cross-Sectional Area	Medial gastrocnemius cross-sectional area will be assessed using B-mode ultrasonography on transverse images. The muscle boundary will be manually traced, and cross-sectional area will be reported in square centimeters (cm²). Higher values indicate greater muscle cross-sectional area.Rectus femoris cross-sectional area will be assessed using B-mode ultrasonography on transverse images. The muscle boundary will be manually traced, and cross-sectional area will be reported in square centimeters (cm²). Higher values indicate greater muscle cross-sectional area.	Baseline, Week 6, and Week 12
Gait speed	Maximum gait speed will be assessed using the 6-Meter Gait Speed Test. Participants will be instructed to walk a straight 6-meter distance as fast as safely possible. The time required to complete the 6-meter distance will be recorded, and gait speed will be calculated as distance divided by time and reported in meters per second (m/s). Higher values indicate faster walking speed and better walking performance.	Baseline, Week 6, and Week 12

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 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): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Locomotion; Walking
• 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