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.
Diagnosed with chronic stroke (≥6 months post-stroke)
Diagnosed with sarcopenia, based on AWGS 2019 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
Parallel
Blood Flow Restriction (BFR) Walking
Procedure/SurgeryParticipants 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 Blood Flow Restriction (Sham-BFR) Walking
Procedure/SurgeryParticipants 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.
Muscle Strength
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.
Motor Function - Fugl-Meyer Assessment (FMA)
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.
Aerobic Capacity and Endurance - Six-Minute Walk Test (6MWT)
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.
Mobility - Timed Up and Go Test (TUG)
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.
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.
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.
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.
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.
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