Acute Cardiovascular and Neuromuscular Responses to Walking With Blood Flow Restriction (BFR) in Older Adults

NCT ID: NCT07275138

Last Updated: 2025-12-10

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2026-01-31

Brief Summary

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The goal of this clinical trial is to explore how walking combined with different levels of partial blood flow restriction (BFR) affects cardiovascular, neuromuscular, and movement (kinematic) variables in older adults.

The main questions it aims to answer are:

Does walking with BFR increase internal effort, as shown by cardiovascular changes, and is this effect proportional to the level of restriction?

Does walking with BFR temporarily reduce neuromuscular control, and is this reduction greater at higher restriction levels?

Does walking with BFR change gait movement patterns?

This study uses a crossover design, meaning that each participant will complete all four conditions and serve as their own control.

Participants will:

Take part in walking sessions under four conditions with different levels of restriction: BFR40%, BFR80%, SHAM (0% BFR), and CON (without BFR).

Have their cardiovascular responses, muscle performance, and gait movement patterns measured.

Report their perceptions of the sessions, including Rate of Perceived Exertion (RPE), satisfaction, and possible side effects.

Detailed Description

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This innovative research project aims to explore the effect of the novel BFR technique, combined with walking, as a non-pharmacological strategy to prevent or reverse sarcopenia and thereby improve the quality of life in sedentary older adults. BFR involves the use of a specialized pneumatic cuff to restrict venous blood flow to a muscle while partially inhibiting arterial flow, and it can be applied either at rest or in combination with exercise.

The application of BFR combined with exercise has shown promise as a tool to induce favorable physiological effects at lower training doses, that is, at lower intensities (e.g., lower intensities or slower walking or running speeds), compared to active control groups. However, despite the promising benefits reported in some studies, comprehensive investigation of the cardiovascular and neuromuscular responses during BFR combined with walking remains a largely unexplored area, both in healthy participants and special populations. This knowledge gap is particularly relevant when considering the substantial benefits that older adults and individuals with mobility limitations could gain from BFR combined with walking, especially given their potential difficulty in adhering to the minimum exercise dosage requirements recommended by the World Health Organization

Conditions

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Healthy Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will perform a walking experimental session under different levels of BFR applied to the lower limbs. The order of BFR conditions will be randomized for each participant. A minimum washout period of 72 hours will be observed between sessions.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants will be unaware of the condition for each session. One researcher sets the BFR, while a second, blinded researcher supervises and assesses the participant. Data will be analyzed by an external analyst using coded data, keeping session conditions unknown.

Study Groups

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BFR40%

BFR set at 40% of the participant's arterial occlusion pressure (AOP).

Group Type EXPERIMENTAL

Walking

Intervention Type BEHAVIORAL

Participants will perform two continuous 10-minute walking bouts, separated by a 3-minute seated recovery period to allow reperfusion following BFR or pause, along a rectangular 40-meter walking circuit (15×5 m). Walking cadence will be standardized at 112 steps per minute.

BFR80%

BFR set at 80% of the participant's AOP.

Group Type EXPERIMENTAL

Walking

Intervention Type BEHAVIORAL

Participants will perform two continuous 10-minute walking bouts, separated by a 3-minute seated recovery period to allow reperfusion following BFR or pause, along a rectangular 40-meter walking circuit (15×5 m). Walking cadence will be standardized at 112 steps per minute.

BFR0%

BFR set at 0% of the participant's AOP.

Group Type SHAM_COMPARATOR

Walking

Intervention Type BEHAVIORAL

Participants will perform two continuous 10-minute walking bouts, separated by a 3-minute seated recovery period to allow reperfusion following BFR or pause, along a rectangular 40-meter walking circuit (15×5 m). Walking cadence will be standardized at 112 steps per minute.

CON

No BFR cuffs.

Group Type ACTIVE_COMPARATOR

Walking

Intervention Type BEHAVIORAL

Participants will perform two continuous 10-minute walking bouts, separated by a 3-minute seated recovery period to allow reperfusion following BFR or pause, along a rectangular 40-meter walking circuit (15×5 m). Walking cadence will be standardized at 112 steps per minute.

Interventions

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Walking

Participants will perform two continuous 10-minute walking bouts, separated by a 3-minute seated recovery period to allow reperfusion following BFR or pause, along a rectangular 40-meter walking circuit (15×5 m). Walking cadence will be standardized at 112 steps per minute.

Intervention Type BEHAVIORAL

Other Intervention Names

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Physical activity Aerobic exercise Cardio exercise Endurance exercise Functional movement

Eligibility Criteria

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Inclusion Criteria

• Aged between 60 and 90 years.

Exclusion Criteria

* Being institutionalized.
* Peripheral vascular disease, defined by an ankle-brachial index (ABI) outside the normal range (0.9-1.4).
* Uncontrolled arterial hypertension (\>180/110 mmHg).
* Any contraindication to exercise, based on self-reported medical history and PAR-Q+.
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Work and Welfare - Xunta de Galicia

OTHER_GOV

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role collaborator

University of La Laguna

OTHER

Sponsor Role collaborator

Universidade da Coruña

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Sport of University of Porto

Porto, Porto District, Portugal

Site Status

Faculty of Education of University of La Laguna

San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

Site Status

Countries

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Portugal Spain

Central Contacts

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Marta Sevilla-Sanchez, Postdoctoral research

Role: CONTACT

34 637 235 257

Facility Contacts

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Lucimere Bohn, Researcher

Role: primary

351 917 028 600

Eduardo Carballeira, PhD

Role: primary

0034-634-476-577

Other Identifiers

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CEFADE40_2024

Identifier Type: -

Identifier Source: org_study_id

ED481B-2024/079

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

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