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Acute Autonomic Responses During and After BFR Training (HOLD TIGHT)

22 juillet 2026 mis à jour par: Egas Moniz - Cooperativa de Ensino Superior, CRL

Acute Cardiac Autonomic Responses During And Following Low-Intensity Blood Flow Restriction Resistance Exercise Versus Conventional High-Intensity Resistance Training In Young And Older Adults

The goal of this clinical trial is to compare how the body's nervous system responds to two different types of leg exercise in young and older adults. One type is low-intensity exercise with blood flow restriction (BFR) , where a cuff partially reduces blood flow to the legs during exercise. The other type is traditional high-intensity resistance training (HIRT), which uses heavier weights.

The main questions it aims to answer are:

Does low-intensity exercise with BFR cause less stress on the nervous system during exercise compared to high-intensity training? Does low-intensity exercise with BFR lead to faster recovery of the nervous system after exercise compared to high-intensity training? Do these responses differ between young adults and older adults? Researchers will compare low-intensity exercise with BFR to high-intensity training to see which approach is gentler on the nervous system during and after exercise.

Participants will:

Attend three visits to the research lab Complete a strength test on leg exercise machines Perform two separate exercise sessions: one with low-intensity exercise and BFR, and one with high-intensity training Have their heart rate, blood pressure, and heart rate variability monitored continuously during and after each exercise session

Aperçu de l'étude

Description détaillée

This is a single-center, prospective, randomized crossover trial with two parallel age groups: young adults (19-24 years) and older adults (60 years and above). The study will be conducted at the Integrative Movement in Networking Systems Laboratory (IMOVE-NET), located at the Physiotherapy Clinic of Egas Moniz School of Health & Science (Almada, Portugal), between October 2026 and June 2027.

All participants will complete three visits, each separated by at least 48 hours to allow for recovery and minimize carryover effects. The first visit serves as a familiarization session, during which participants will have baseline cardiovascular measurements taken, become acquainted with the exercise protocol, and undergo one-repetition maximum (1RM) testing for the bilateral leg press and knee extension exercises. Body composition measurements will also be collected. Participants are instructed to avoid caffeine and alcohol for 24 hours, refrain from vigorous physical activity for 24 hours, and fully void before each session.

Following the familiarization visit, participants are randomly assigned to the order in which they will receive the two experimental conditions: (1) low-intensity resistance training with blood flow restriction (LIRT-BFR), and (2) high-intensity resistance training (HIRT). The randomization sequence will be generated using a web-based tool, placed in sequentially numbered, opaque, sealed envelopes, and concealed until the day of each visit. Simple randomization will be performed separately within each age group, generating independent session-order sequences for older and younger participants.

Each experimental session begins with a 15-minute resting phase in a supine position, during which heart rate and blood pressure are recorded. Beat-to-beat systolic and diastolic blood pressure will be recorded using finger plethysmography (Finapres Nova), and R-R intervals will be sampled at 300 Hz via the integrated 5-lead electrocardiogram (ECG) module. Intermittent brachial blood pressure readings from the contralateral arm (SunTech Tango+ automated auscultatory sphygmomanometer) will validate continuous Finapres measurements, particularly during exercise conditions. Continuous 2-minute segments of artifact-free R-R interval and systolic blood pressure (SBP) time series will be constructed for analysis.

Participants then perform the assigned exercise condition for approximately 30 minutes, consisting of bilateral knee extensions and leg curls. In the HIRT condition, participants perform 3 sets of 10 repetitions at 75% of 1RM with 2-minute rest intervals. In the LIRT-BFR condition, participants perform 4 sets of 20 repetitions at 30% of 1RM with a 5 cm wide pneumatic cuff applied to the most proximal portion of both thighs, inflated to 1.3 times the individual's ankle systolic blood pressure (SBP). The cuff remains inflated continuously throughout sets and rest periods and is released immediately after the final repetition. Exercise intensity, heart rate, rate of perceived exertion (RPE) using the modified Borg scale (0-10), and perceived discomfort are continuously monitored throughout both conditions. If a participant reports a discomfort score greater than 7, cuff pressure is immediately reduced from 1.3 to 1.2 times ankle SBP. If volitional fatigue prevents completion of repetitions, pressure is reduced to facilitate completion while maintaining a safe hemodynamic profile.

After each experimental condition, participants immediately return to the examination table and recover in a supine position for 60 minutes, during which blood pressure and heart rate are continuously re-evaluated. All data acquisition and offline analyses will follow relevant task force standards for heart rate variability and baroreflex sensitivity measurement.

The intervention will be administered by physiotherapy students who have completed 20 hours of technical training in exercise protocols and autonomic evaluation using the Finapres Nova system, maintaining an investigator-to-participant ratio of 2:1 to ensure safety and precision. Predefined stopping rules will be applied in the event of any adverse event or clinically relevant safety concern. The study supervisor will randomly review and audit 15% of total sessions to identify and correct procedural errors. Protocol adherence is strictly monitored and defined as the percentage of the prescribed protocol successfully completed; a minimum threshold of 70% will be required for any individual session to be considered valid for analysis.

Type d'étude

Interventionnel

Inscription (Estimé)

48

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Monte Da Caparica
      • Almada, Monte Da Caparica, Le Portugal, 2829-511
        • Egas Moniz School of Health and Science
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Young adults aged 18-24 years
  • Older adults aged 60 years and above
  • Willing and able to provide written informed consent
  • Able to comply with study procedures and visit schedule

Exclusion Criteria:

  • Medications affecting cardiac activity (e.g., beta-blockers, calcium channel blockers, antiarrhythmics)
  • Tobacco use
  • Sleep apnea
  • Body mass index (BMI) greater than 30 kg/m²
  • Regular exercise training (more than 150 minutes per week for more than 6 months)
  • History of coronary heart disease
  • History of stroke
  • History of oncological disease
  • History of major cardiovascular events
  • Peripheral vascular disease
  • Uncontrolled hypertension
  • Diabetes mellitus
  • Unstable angina
  • Active kidney or liver disease
  • Chronic obstructive pulmonary disease (COPD)
  • Recent surgical procedure (within the last two months)
  • Neurological impairments affecting exercise capacity
  • Orthopedic impairments affecting exercise capacity
  • Sensory impairments affecting exercise capacity

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Pas d'exercice ni de restriction du flux sanguin
Expérimental: Low-Intensity + Blood Flow Restriction
Participants perform bilateral knee extensions and leg curls at 30% of their one-repetition maximum (1RM) while a pneumatic cuff is applied to the most proximal portion of both thighs. The cuff is inflated to 1.3 times the individual's ankle systolic blood pressure. The protocol consists of 4 sets of 20 repetitions with 30-second rest intervals between sets. Total exercise duration is approximately 30 minutes. Cuff pressure is maintained continuously throughout sets and rest periods and is released immediately after the final repetition.
Comparateur actif: High-Intensity Resistance Training (HIRT)
Participants perform bilateral knee extensions and leg curls at 75% of their one-repetition maximum (1RM). The protocol consists of 3 sets of 10 repetitions with 2-minute rest intervals between sets. Total exercise duration is approximately 30 minutes.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in Time-Domain Heart Rate Variability Indices
Délai: Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Mean change from baseline in time-domain heart rate variability indices: RMSSD (root mean square of successive differences, reflecting vagal modulation), SDNN (standard deviation of normal-to-normal intervals, reflecting overall autonomic modulation), and pNN50 (percentage of successive R-R intervals >50 ms). These indices will be derived from continuous R-R interval recordings (Finapres Nova) during supine rest. Higher values indicate better parasympathetic modulation and autonomic flexibility.
Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in Frequency-Domain Heart Rate Variability Indices
Délai: Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Mean change from baseline in frequency-domain heart rate variability indices: low-frequency power (LF, ms²), high-frequency power (HF, ms²), and LF/HF ratio. Spectral analysis will be performed using a Daubechies-12 discrete wavelet transform on continuous R-R interval recordings (Finapres Nova) during supine rest. Higher HF indicates better parasympathetic modulation; lower LF/HF ratio indicates better sympathovagal balance.
Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Changes in Non-Linear Heart Rate Variability Indices
Délai: Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Mean change from baseline in non-linear heart rate variability indices derived from Poincaré plot analysis: SD1 (reflecting short-term variability, predominantly parasympathetic modulation), SD2 (reflecting long-term variability, overall autonomic modulation), and SD1/SD2 ratio. Derived from continuous R-R interval recordings (Finapres Nova) during supine rest.
Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Changes in Cardiovagal Baroreflex Sensitivity (BRS)
Délai: Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Mean change from baseline in baroreflex sensitivity (BRS) estimated using the spontaneous sequence method, which identifies concordant systolic blood pressure and R-R interval ramps. BRS gain is expressed as ms/mmHg. Higher BRS gain indicates better reflex integrity and better blood pressure stability.
Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Changes in Blood Pressure
Délai: Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Mean change from baseline in beat-to-beat systolic blood pressure (SBP) and diastolic blood pressure (DBP). Both measures will be derived from finger plethysmography (Finapres Nova) during supine rest, validated against brachial readings (SunTech Tango+). Units: mmHg. For SBP, higher values indicate higher cardiovascular load. For DBP, higher values indicate higher cardiovascular load.
Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

5 octobre 2026

Achèvement primaire (Estimé)

14 mai 2027

Achèvement de l'étude (Estimé)

25 juin 2027

Dates d'inscription aux études

Première soumission

20 juillet 2026

Première soumission répondant aux critères de contrôle qualité

22 juillet 2026

Première publication (Réel)

23 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Data obtained in this study may be provided to qualified researchers with academic interest in autonomic responses to resistance training with blood flow restriction. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Délai de partage IPD

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

Critères d'accès au partage IPD

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact xmelo@egasmoniz.edu.pt

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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