Clinical trial NCT06974461: Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function for Stroke-Related Sarcopenia
Official title: Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function in Individuals With Stroke-Related Sarcopenia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia
Chronic Stroke Patients
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with chronic stroke (≥6 months post-stroke)
* Diagnosed with sarcopenia, based on AWGS 2019 criteria

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)

Primary outcomes:
measure: Muscle Strength
timeFrame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
measure: Motor Function - Fugl-Meyer Assessment (FMA)
timeFrame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
measure: Aerobic Capacity and Endurance - Six-Minute Walk Test (6MWT)
timeFrame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
measure: Mobility - Timed Up and Go Test (TUG)
timeFrame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
measure: Gait Speed - 10-Meter Walk Test (10MWT)
timeFrame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
measure: Five Times Sit-to-Stand Test (FTSTS)
timeFrame: Baseline, Week 6, Week 12
measure: Handgrip Strength
timeFrame: Baseline, Week 6, Week 12
Secondary outcomes:
measure: Nutritional Status - Mini Nutritional Assessment Short Form (MNA-SF)
timeFrame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
measure: Quality of Life - Sarcopenia and Quality of Life Questionnaire (SarQoL)
timeFrame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)
measure: Appendicular Skeletal Muscle Mass (ASM)
timeFrame: Baseline, Week 6, Week 12
measure: Muscle Thickness (MT)
timeFrame: Baseline, Week 6, Week 12
measure: Pennation Angle
timeFrame: Baseline, Week 6, Week 12
measure: Cross-Sectional Area (CSA)
timeFrame: Baseline, Week 6, Week 12
measure: Echo Intensity (EI)
timeFrame: Baseline, Week 6, Week 12
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: Hong Kong Polytechnic University
state: Kowloon
Study officials:
References: