- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07722403
Acute Autonomic Responses During and After BFR Training (HOLD TIGHT)
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
Postavení
Podmínky
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
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Xavier Melo, PhD
- Telefonní číslo: +351 212946700
- E-mail: xmelo@egasmoniz.edu.pt
Studijní místa
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Monte Da Caparica
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Almada, Monte Da Caparica, Portugalsko, 2829-511
- Egas Moniz School of Health and Science
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Kontakt:
- Xavier Melo, PhD
- Telefonní číslo: 00351212946700
- E-mail: xmelo@egasmoniz.edu.pt
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
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
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 |
|---|---|
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Žádný zásah: Žádné cvičení nebo omezení průtoku krve
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Experimentální: Low-Intensity + Blood Flow Restriction
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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.
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Aktivní komparátor: High-Intensity Resistance Training (HIRT)
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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)
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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.
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Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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)
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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.
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Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
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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)
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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.
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Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
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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)
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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.
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Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
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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)
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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.
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Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Grassler B, Thielmann B, Bockelmann I, Hokelmann A. Effects of different exercise interventions on heart rate variability and cardiovascular health factors in older adults: a systematic review. Eur Rev Aging Phys Act. 2021 Nov 17;18(1):24. doi: 10.1186/s11556-021-00278-6.
- Oliveira RS, Vitor da Costa M, Pedro RE, Polito MD, Avelar A, Cyrino ES, Nakamura FY. Acute cardiac autonomic responses after a bout of resistance exercise. Sci Sports. 2012;27(6):357-364.
- Okuno NM, Pedro RE, Leicht AS, de Paula Ramos S, Nakamura FY. Cardiac autonomic recovery after a single session of resistance exercise with and without vascular occlusion. J Strength Cond Res. 2014 Apr;28(4):1143-50. doi: 10.1519/JSC.0000000000000245.
- Ganzarolli Stevanatto LC, Venturini Ferreira ML, Bonganha V, de Souza GV, Cavaglieri CR, Chacon Mikahil MPT. Acute cardiac autonomic responses to resistance exercise with and without blood flow restriction. Sci Sports. 2022;37(5-6):454-458. DOI: 10.1016/j.scispo.2022.04.001
- Ferreira MLV, Sardeli AV, Souza GV, Bonganha V, Santos LDC, Castro A, Cavaglieri CR, Chacon-Mikahil MPT. Cardiac autonomic and haemodynamic recovery after a single session of aerobic exercise with and without blood flow restriction in older adults. J Sports Sci. 2017 Dec;35(24):2412-2420. doi: 10.1080/02640414.2016.1271139. Epub 2016 Dec 28.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- HOLD TIGHT 2.0
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
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