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

NCT ID: NCT06974461

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2027-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia Chronic Stroke Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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BFR Walking Group

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.

Group Type EXPERIMENTAL

Blood Flow Restriction (BFR) Walking

Intervention Type 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.

Sham-BFR Walking Group

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).

Group Type SHAM_COMPARATOR

Sham Blood Flow Restriction (Sham-BFR) Walking

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Yingxiu Diao, Master

Role: CONTACT

+8614796733917

Facility Contacts

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Yingxiu Diao, Master

Role: primary

8614796733917

Yarou Yuan, Master

Role: backup

Other Identifiers

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HSEARS20250109003

Identifier Type: -

Identifier Source: org_study_id

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