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Not yet recruiting NCT06974461

Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function for Stroke-Related Sarcopenia

No phase Interventional Sarcopenia Chronic Stroke Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood Flow Restriction (BFR) Walking, Sham Blood Flow Restriction (Sham-BFR) Walking.
Who it may be relevant to
Registry conditions: Sarcopenia, Chronic Stroke Patients. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function in Individuals With Stroke-Related Sarcopenia: A Randomized Controlled Trial

Overview

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

  • Procedure Blood 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.
  • Procedure Sham 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.

Primary outcome measures

  • Muscle Strength [Time frame: baseline (prior to intervention), 6 weeks post-intervention (End), and 6 weeks after the end of the intervention (Follow-up)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • Five Times Sit-to-Stand Test (FTSTS) [Time frame: Baseline, Week 6, Week 12]
  • Handgrip Strength [Time frame: Baseline, Week 6, Week 12]
Secondary outcome measures (7)
  • 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]
  • Pennation Angle [Time frame: Baseline, Week 6, Week 12]
  • Cross-Sectional Area (CSA) [Time frame: Baseline, Week 6, Week 12]
  • Echo Intensity (EI) [Time frame: Baseline, Week 6, Week 12]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Hong Kong Polytechnic University — Hung Hom

Identifiers

NCT: NCT06974461 · HSEARS20250109003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗