SarcopeniaNCT06974461
Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function for Stroke-Related Sarcopenia
A study testing Blood Flow Restriction (BFR) Walking in people with Sarcopenia and Chronic Stroke Patients, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sarcopenia, Chronic Stroke Patients
- What is being tested?
- Blood Flow Restriction (BFR) Walking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Sep 2025to 28 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Not yet recruiting
Hong Kong Polytechnic University
Hung Hom, Kowloon, 999077
Yingxiu Diao, Master, 8614796733917, 24039355r@connect.polyu.hk
Yarou Yuan, Master, 90495235, sabrina.yuan@connect.polyu.hk
- Recruiting
Hong Kong Polytechnic University
Hung Hom, Kowloon, 999077
Jingquan Cai, Master, +85294149862, kingston.cai@polyu.edu.hk
Yingxiu Diao, Master
About this study
Official title: 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.
- Conditions
- Sarcopenia, Chronic Stroke Patients
- Being tested
- Blood Flow Restriction (BFR) Walking, Sham Blood Flow Restriction (Sham-BFR) Walking
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction (BFR) WalkingProcedure or surgery
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 Blood Flow Restriction (Sham-BFR) WalkingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| BFR Walking Group | Experimental | 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. Receives: Procedure: Blood Flow Restriction (BFR) Walking |
| Sham-BFR Walking Group | Sham comparator | 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). Receives: Procedure: Sham Blood Flow Restriction (Sham-BFR) Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Sep 2025
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974461
- Sponsor's protocol ID
- HSEARS20250109003
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Training on Physical Performance in Individuals With Stroke-Related Sarcopenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06974461
- Acronym / sponsor ID
- HSEARS20250109003
- Conditions
- Sarcopenia, Chronic Stroke Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR Walking Group | Experimental | Procedure: Blood Flow Restriction (BFR) WalkingParticipants 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. |
| Sham-BFR Walking Group | Sham comparator | Procedure: Sham Blood Flow Restriction (Sham-BFR) WalkingParticipants 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction (BFR) WalkingParticipants 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. | Procedure or surgery | BFR Walking Group |
| Sham Blood Flow Restriction (Sham-BFR) WalkingParticipants 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. | Procedure or surgery | Sham-BFR Walking Group |
Primary outcome
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.
10 secondary outcomes
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)
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)
Appendicular Skeletal Muscle Mass (ASM)
Time frame: Baseline, Week 6, Week 12
Muscle Thickness (MT)
Time frame: Baseline, Week 6, Week 12
Six-Minute Walk Distance
Time frame: Baseline, Week 6, and Week 12
Berg Balance Scale
Time frame: Baseline, Week 6, and Week 12
Timed Up and Go Test
Time frame: Baseline, Week 6, and Week 12
Five-Times Sit-to-Stand Test
Time frame: Baseline, Week 6, and Week 12
Cross-Sectional Area
Time frame: Baseline, Week 6, and Week 12
Gait speed
Time frame: Baseline, Week 6, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction (BFR) Walking in people with Sarcopenia and Chronic Stroke Patients, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingxiu Diao, Master (+8614796733917, 24039355r@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength (time frame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.