Effects of Blood Flow Restriction Training on Physical Performance in Individuals With Stroke-Related Sarcopenia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 64
- Locations
- 4
- Primary Endpoint
- Motor Function - Fugl-Meyer Assessment (FMA)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
Handgrip Strength
Time Frame: Baseline, Week 6, Week 12
Handgrip strength will be measured in kilograms (kg) using a digital hand dynamometer.
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 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.
Secondary Outcomes
- Nutritional Status - Mini Nutritional Assessment Short Form (MNA-SF)(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)(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)(Baseline, Week 6, Week 12)
- Muscle Thickness (MT)(Baseline, Week 6, Week 12)
- Pennation Angle(Baseline, Week 6, Week 12)
- Cross-Sectional Area (CSA)(Baseline, Week 6, Week 12)
- Echo Intensity (EI)(Baseline, Week 6, Week 12)
- Six-Minute Walk Distance(Baseline, Week 6, and Week 12)
- Berg Balance Scale(Baseline, Week 6, and Week 12)
- Timed Up and Go Test(Baseline, Week 6, and Week 12)
- Five-Times Sit-to-Stand Test(Baseline, Week 6, and Week 12)
- Cross-Sectional Area(Baseline, Week 6, and Week 12)
- Gait speed(Baseline, Week 6, and Week 12)