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Not yet recruiting NCT07275138

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

No phase Interventional Healthy Older Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Walking.
Who it may be relevant to
Registry conditions: Healthy Older Adults. Basic parameters: 60 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Blood pressure [Time frame: 25 minutes]
  • Heart rate [Time frame: 60 minutes]
  • RR-Interval Time-Domain Metrics [Time frame: 60 minutes]
  • RR-Interval Nonlinear Metric [Time frame: 60 minutes]
  • Maximum isometric strength [Time frame: 10 minutes]
  • Force steadiness [Time frame: 10 minutes]
Secondary outcome measures (7)
  • Arterial stiffness [Time frame: 25 minutes]
  • Temporal Gait Parameters [Time frame: 20 minutes]
  • Temporal Gait Variability [Time frame: 20 minutes]
  • Postural Stability [Time frame: 10 minutes]
  • Internal subjective load [Time frame: 20 minutes]
  • Adverse effects [Time frame: 20 minutes]
  • Affective Responses [Time frame: 20 minutes]

Eligibility criteria

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+.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Portugal · 1 center
  • Faculty of Sport of University of Porto — Porto
Spain · 1 center
  • Faculty of Education of University of La Laguna — San Cristóbal de La Laguna

Identifiers

NCT: NCT07275138 · CEFADE40_2024 · ED481B-2024/079

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗