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

NCT06974461 | Not Yet Recruiting DMC

• 1 other identifier: HSEARS20250109003
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Chronic Stroke Patients

Outcome Measures

Primary Outcomes (7)

• Muscle Strength

  Isometric peak torque of the target muscle groups will be measured during both extension and flexion using an isokinetic dynamometer. The unit of measurement is Newton-meters (Nm). Higher values indicate greater muscle strength.

  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)

  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.

  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)

  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.

  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)

  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.

  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)

  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.

  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)

  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.

  Baseline, Week 6, Week 12

• Handgrip Strength

  Handgrip strength will be measured in kilograms (kg) using a digital hand dynamometer.

  Baseline, Week 6, Week 12

Secondary Outcomes (7)

• 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

Study Arms (2)

BFR Walking Group

EXPERIMENTAL

Participants in this group will receive blood flow restriction (BFR) walking training. The pressure cuffs will be applied to the proximal thighs. Walking sessions will be conducted on a treadmill at 60% of the participant's maximum walking speed, 3 times per week for 6 weeks. The cuff pressure will begin at 50% of each participant's arterial occlusion pressure (AOP), determined via Doppler ultrasound, and progressively increased every two weeks to a maximum of 200 mmHg.

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).

Procedure: Sham Blood Flow Restriction (Sham-BFR) Walking

Interventions

Blood Flow Restriction (BFR) Walking PROCEDURE

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.

BFR Walking Group

Sham Blood Flow Restriction (Sham-BFR) Walking PROCEDURE

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.

Sham-BFR Walking Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Hong Kong Polytechnic University

Hung Hom, Kowloon, 999077, Hong Kong

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Walking

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Central Study Contacts

Yingxiu Diao, Master

CONTACT

+8614796733917; 24039355r@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: May 16, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

HK (1)