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
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Xavier Melo, PhD
- 电话号码:+351 212946700
- 邮箱:xmelo@egasmoniz.edu.pt
学习地点
-
-
Monte Da Caparica
-
Almada、Monte Da Caparica、葡萄牙、2829-511
- Egas Moniz School of Health and Science
-
接触:
- Xavier Melo, PhD
- 电话号码:00351212946700
- 邮箱:xmelo@egasmoniz.edu.pt
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:无运动或血流限制
|
|
|
实验性的: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.
|
|
有源比较器: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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Time-Domain Heart Rate Variability Indices
大体时间: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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Frequency-Domain Heart Rate Variability Indices
大体时间: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
大体时间: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)
大体时间: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
大体时间: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)
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.