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

Acute Cardiovascular and Neuromuscular Responses to Walking With Blood Flow Restriction in Older Adults: a Study Protocol for a Randomized Crossover Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Older Adults
• Intervention / Treatment: Behavioral: Walking

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Sevilla-Sanchez, Postdoctoral research; Phone Number: 34 637 235 257; Email: marta.sevilla@udc.es

Study Locations

• Portugal
  • Porto District
    • Porto, Porto District, Portugal, 4200-450
      • Faculty of Sport of University of Porto
      • Contact: Lucimere Bohn, Researcher; Phone Number: 351 917 028 600; Email: lucimerebohn@fade.up.pt
• Spain
  • Santa Cruz de Tenerife
    • San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain, 38204
      • Faculty of Education of University of La Laguna
      • Contact: Eduardo Carballeira, PhD; Phone Number: 0034-634-476-577; Email: ecarball@ull.edu.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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+.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BFR40%; BFR set at 40% of the participant's arterial occlusion pressure (AOP).	Behavioral: 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.; Other Names: Physical activity; Aerobic exercise; Endurance exercise; Cardio exercise; Functional movement
Experimental: BFR80%; BFR set at 80% of the participant's AOP.	Behavioral: 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.; Other Names: Physical activity; Aerobic exercise; Endurance exercise; Cardio exercise; Functional movement
Sham Comparator: BFR0%; BFR set at 0% of the participant's AOP.	Behavioral: 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.; Other Names: Physical activity; Aerobic exercise; Endurance exercise; Cardio exercise; Functional movement
Active Comparator: CON; No BFR cuffs.	Behavioral: 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.; Other Names: Physical activity; Aerobic exercise; Endurance exercise; Cardio exercise; Functional movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg	25 minutes
Heart rate	The average and maximum values will be obtained using a chest-worn heart rate sensor. Unit: beats per minute (bpm)	60 minutes
RR-Interval Time-Domain Metrics	Standard time-domain HRV metrics-including mean RR intervals (meanRR), the standard deviation of normal-to-normal intervals (SDNN), and the root mean square of successive differences (RMSSD)-will be derived from inter-beat interval data exported from a chest-worn heart rate sensor (epochs of 5 min). Units: milliseconds (ms).	60 minutes
RR-Interval Nonlinear Metric	Short-term fractal scaling (DFA α1) will be calculated from inter-beat interval data exported from a chest-worn heart rate sensor (epochs of 5 min). Units: dimensionless.	60 minutes
Maximum isometric strength	Maximum voluntary isometric contraction (MVIC) force during a knee-extension task will be recorded using a force-gauge device. Unit: Newtons (N)	10 minutes
Force steadiness	Force steadiness will be evaluated from the RMSSD of the coefficient of variation (CV) during a 30-s submaximal isometric knee-extension contraction at 30% MVIC, using a force-gauge device with data-analysis software. Unit: Percentage (%)	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial stiffness	It will be assessed by finger-toe pulse wave velocity (PWV) method. Units: m/s	25 minutes
Temporal Gait Parameters	Mean temporal gait parameters-including stride time, step time, and stance time-will be derived from IMU-based measurements. Units: milliseconds (ms).	20 minutes
Temporal Gait Variability	Stride-to-stride temporal variability (stride time, step time, stance time) will be computed from walking recordings collected using a wearable inertial measurement unit (IMU) equipped with a triaxial accelerometer and gyroscope. Variability will be expressed as the coefficient of variation (CV) for each temporal metric. Units: Percentage (%)	20 minutes
Postural Stability	Postural stability in mediolateral (ML) and anterior-posterior (AP) directions will be assessed during quiet standing under four conditions (eyes open/closed × firm/foam surface). A wearable IMU will record triaxial centre-of-mass acceleration. Stability metrics will be computed as -ln[m/s²], where higher values reflect lower acceleration and therefore better postural control. Units: -ln[m/s²]	10 minutes
Internal subjective load	Perceived exertion during walking will be quantified every 5 minutes using the OMNI-RES scale. Units: Points (0-10).	20 minutes
Adverse effects	Severity of adverse sensations (e.g., tingling, burning, numbness, fatigue, discomfort, petechiae) potentially associated with BFR will be recorded. Units: Points (0-5).	20 minutes
Affective Responses	Affective valence during the exercise bout will be assessed using the Visual Analogue Feeling Scale. Units: Points (-5 to +5).	20 minutes

Collaborators and Investigators

• Sponsor: Universidade da Coruña
• Collaborators: Universidade do Porto; Ministry of Work and Welfare - Xunta de Galicia; University of La Laguna

Study record dates

Study Major Dates

• Study Start (Estimated): December 8, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Elderly; safety; Aerobic exercise; older adults; Physical activity; Physical Function; functionality; walking; exercise training; Endurance training; walking exercise; walking training; Crossover Study; Community-dwelling; Senior; Blood Flow Restriction (BFR); Neuromuscular Performance; Gait Kinematic; Cardiovascular Response; Low-impact exercise; Age 60+; Non-institutionalized; Partial Blood Flow Restriction; Limb Occlusion Training; Vascular Occlusion Training; KAATSU Training; Low-load resistance training with BFR; Occlusion exercise
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Locomotion; Exercise; Walking
• Other Study ID Numbers: CEFADE40_2024; ED481B-2024/079 (Other Grant/Funding Number: Xunta de Galicia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No