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

22. července 2026 aktualizováno: 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

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

48

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Monte Da Caparica
      • Almada, Monte Da Caparica, Portugalsko, 2829-511
        • Egas Moniz School of Health and Science
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Žádné cvičení nebo omezení průtoku krve
Experimentální: 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.
Aktivní komparátor: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in Time-Domain Heart Rate Variability Indices
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in Frequency-Domain Heart Rate Variability Indices
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

5. října 2026

Primární dokončení (Odhadovaný)

14. května 2027

Dokončení studie (Odhadovaný)

25. června 2027

Termíny zápisu do studia

První předloženo

20. července 2026

První předloženo, které splnilo kritéria kontroly kvality

22. července 2026

První zveřejněno (Aktuální)

23. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • HOLD TIGHT 2.0

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení 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.

Kritéria přístupu pro sdílení 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

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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