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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07275138
Enrollment
20
Registered
2025-12-10
Start date
2025-12-08
Completion date
2026-01-31
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Older Adults

Keywords

Blood Flow Restriction (BFR), walking exercise, older adults, Gait Kinematic, Cardiovascular Response, Neuromuscular Performance, Crossover Study, Physical Function, safety, Endurance training, Low-impact exercise, Aerobic exercise, Physical activity, functionality, Elderly, Senior, Age 60+, Community-dwelling, Non-institutionalized, Partial Blood Flow Restriction, Limb Occlusion Training, Vascular Occlusion Training, KAATSU Training, Low-load resistance training with BFR, Occlusion exercise, walking, walking training, exercise training

Brief summary

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

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

Interventions

BEHAVIORALWalking

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.

Sponsors

Ministry of Work and Welfare - Xunta de Galicia
CollaboratorOTHER_GOV
Universidade do Porto
CollaboratorOTHER
University of La Laguna
CollaboratorOTHER
Universidade da Coruña
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No

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+.

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure25 minutesSystolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg
Heart rate60 minutesThe average and maximum values will be obtained using a chest-worn heart rate sensor. Unit: beats per minute (bpm)
RR-Interval Time-Domain Metrics60 minutesStandard 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).
RR-Interval Nonlinear Metric60 minutesShort-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.
Maximum isometric strength10 minutesMaximum voluntary isometric contraction (MVIC) force during a knee-extension task will be recorded using a force-gauge device. Unit: Newtons (N)
Force steadiness10 minutesForce 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 (%)

Secondary

MeasureTime frameDescription
Arterial stiffness25 minutesIt will be assessed by finger-toe pulse wave velocity (PWV) method. Units: m/s
Affective Responses20 minutesAffective valence during the exercise bout will be assessed using the Visual Analogue Feeling Scale. Units: Points (-5 to +5).
Temporal Gait Parameters20 minutesMean temporal gait parameters-including stride time, step time, and stance time-will be derived from IMU-based measurements. Units: milliseconds (ms).
Temporal Gait Variability20 minutesStride-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 (%)
Postural Stability10 minutesPostural 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\[m/s²\]
Internal subjective load20 minutesPerceived exertion during walking will be quantified every 5 minutes using the OMNI-RES scale. Units: Points (0-10).
Adverse effects20 minutesSeverity of adverse sensations (e.g., tingling, burning, numbness, fatigue, discomfort, petechiae) potentially associated with BFR will be recorded. Units: Points (0-5).

Countries

Portugal, Spain

Contacts

Primary ContactMarta Sevilla-Sanchez, Postdoctoral research
marta.sevilla@udc.es34 637 235 257

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026