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

NCT07275138 | Not Yet Recruiting

• 2 other identifiers: CEFADE40_2024ED481B-2024/079
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Arterial stiffness

  25 minutes

• Temporal Gait Parameters

  20 minutes

• Temporal Gait Variability

  20 minutes

• Postural Stability

  10 minutes

• Internal subjective load

  20 minutes

Study Arms (4)

BFR40%

EXPERIMENTAL

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

Behavioral: Walking

BFR80%

EXPERIMENTAL

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

Behavioral: Walking

BFR0%

SHAM COMPARATOR

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

Behavioral: Walking

CON

ACTIVE COMPARATOR

No BFR cuffs.

Behavioral: Walking

Interventions

Walking 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.

Also known as: Physical activity, Aerobic exercise, Cardio exercise, Endurance exercise, Functional movement

BFR0%; BFR40%; BFR80%; CON

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 60 and 90 years.

You may not qualify if:

• 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+.

Sponsors & Collaborators

• Universidade da Coruña: lead
• Ministry of Work and Welfare - Xunta de Galicia: collaborator
• Universidade do Porto: collaborator
• University of La Laguna: collaborator

Study Sites (2)

Faculty of Sport of University of Porto

Porto, Porto District, 4200-450, Portugal

Location

Faculty of Education of University of La Laguna

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

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Walking; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity

Central Study Contacts

Marta Sevilla-Sanchez, Postdoctoral research

CONTACT

34 637 235 257; marta.sevilla@udc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 10, 2025
• Study Start: December 8, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1); ES (1)