Chronic Stroke Patients, Sarcopenia
Conditions
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.
Interventions
PROCEDUREBlood 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.
PROCEDURESham 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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | 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. |
| Appendicular Skeletal Muscle Mass (ASM) | 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. |
| Muscle Thickness (MT) | 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. |
| Six-Minute Walk Distance | Baseline, Week 6, and Week 12 | 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. |
| Berg Balance Scale | Baseline, Week 6, and Week 12 | 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. |
| Timed Up and Go Test | Baseline, Week 6, and Week 12 | 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. |
| Five-Times Sit-to-Stand Test | Baseline, Week 6, and Week 12 | 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. |
| Cross-Sectional Area | Baseline, Week 6, and Week 12 | 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. |
| Gait speed | Baseline, Week 6, and Week 12 | 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. |
Countries
Hong Kong
Contacts
CONTACTYingxiu Diao, Master
Outcome results
None listed