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Healthy Older AdultsNCT07275138

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

A study testing Walking in people with Healthy Older Adults, run by Universidade da Coruña at 2 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 90 years
Conditions the study is for
Healthy Older Adults
What is being tested?
Walking
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
2 sitesin 2 countries
Study dates
8 Dec 2025to Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 60 and 90 years.

Who cannot join

  • 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+.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Marta Sevilla-Sanchez, Postdoctoral research contact

34 637 235 257

marta.sevilla@udc.es

2 sites in 2 countries

Portugal1 site

  • Faculty of Sport of University of Porto

    Porto, Porto District, 4200-450

    Lucimere Bohn, Researcher, 351 917 028 600, lucimerebohn@fade.up.pt

Other trials in Portugal

Spain1 site

  • Faculty of Education of University of La Laguna

    San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38204

    Eduardo Carballeira, PhD, 0034-634-476-577, ecarball@ull.edu.es

Other trials in Spain

About this study

Official title: 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:

Read more

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.

Read the 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

Being tested
Walking
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
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WalkingBehavioural

    Also called Physical activity, Aerobic exercise, Cardio exercise, Endurance exercise

    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.

Study groups in NCT07275138
Study groupRoleWhat they receive
BFR40%ExperimentalBFR set at 40% of the participant's arterial occlusion pressure (AOP).
Receives: Behavioral: Walking
BFR80%ExperimentalBFR set at 80% of the participant's AOP.
Receives: Behavioral: Walking
BFR0%Sham comparatorBFR set at 0% of the participant's AOP.
Receives: Behavioral: Walking
CONActive comparatorNo BFR cuffs.
Receives: Behavioral: Walking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure

    Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg

    Measured: 25 minutes

  2. Heart rate

    The average and maximum values will be obtained using a chest-worn heart rate sensor. Unit: beats per minute (bpm)

    Measured: 60 minutes

  3. 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).

    Measured: 60 minutes

  4. 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.

    Measured: 60 minutes

  5. 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)

    Measured: 10 minutes

  6. 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 (%)

    Measured: 10 minutes

Secondary outcomes (7)

  1. Arterial stiffness

    It will be assessed by finger-toe pulse wave velocity (PWV) method. Units: m/s

    Measured: 25 minutes

  2. 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).

    Measured: 20 minutes

  3. 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 (%)

    Measured: 20 minutes

  4. 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]

    Measured: 10 minutes

  5. Internal subjective load

    Perceived exertion during walking will be quantified every 5 minutes using the OMNI-RES scale.

    Units: Points (0-10).

    Measured: 20 minutes

  6. 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).

    Measured: 20 minutes

  7. Affective Responses

    Affective valence during the exercise bout will be assessed using the Visual Analogue Feeling Scale.

    Units: Points (-5 to +5).

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study start8 Dec 2025 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07275138
Sponsor's protocol ID
CEFADE40_2024
Other IDs
ED481B-2024/079
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Walking in people with Healthy Older Adults, run by Universidade da Coruña at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marta Sevilla-Sanchez, Postdoctoral research (34 637 235 257, marta.sevilla@udc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure (time frame: 25 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07275138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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