Blood Flow Restriction ExerciseHOLD TIGHTNCT07722403
Acute Autonomic Responses During and After BFR Training
A study testing High-Intensity Resistance Training (HIRT) and Low-Intensity Resistance Training with Blood Flow Restriction (LIRT-BFR) in people with Blood Flow Restriction Exercise and Aging, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction Exercise, Aging
- What is being tested?
- High-Intensity Resistance Training (HIRT) and Low-Intensity Resistance Training with Blood Flow Restriction (LIRT-BFR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Oct 2026to 25 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Egas Moniz School of Health and Science
Almada, Monte Da Caparica, 2829-511
Xavier Melo, PhD, 00351212946700, xmelo@egasmoniz.edu.pt
About this study
Official title: 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:
Read more
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
Read the detailed description
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.
- Conditions
- Blood Flow Restriction Exercise, Aging
- Being tested
- High-Intensity Resistance Training (HIRT), Low-Intensity Resistance Training with Blood Flow Restriction (LIRT-BFR)
- Keywords
- blood flow restriction, cardiovagal modulation, resistance exercise, young adults, older adults, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Resistance Training (HIRT)Other
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.
Low-Intensity Resistance Training with Blood Flow Restriction (LIRT-BFR)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity + Blood Flow Restriction | Experimental | Not described Receives: Other: Low-Intensity Resistance Training with Blood Flow Restriction (LIRT-BFR) |
| High-Intensity Resistance Training (HIRT) | Active comparator | Not described Receives: Other: High-Intensity Resistance Training (HIRT) |
| No exercise or blood flow restriction | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Time-Domain Heart Rate Variability Indices
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.
Measured: Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Secondary outcomes (4)
Changes in Frequency-Domain Heart Rate Variability Indices
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start5 Oct 2026 (estimated)
- Primary completion14 May 2027 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Blood Flow Restriction ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parallel group crossover randomized trial
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722403
- Sponsor's protocol ID
- HOLD TIGHT 2.0
- Acronym
- HOLD TIGHT
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
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.
PubMed 34789148Okuno 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.
PubMed 24077384Ganzarolli 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.
PubMed 28029066
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07722403
- Acronym / sponsor ID
- HOLD TIGHT / HOLD TIGHT 2.0
- Conditions
- Blood Flow Restriction Exercise, Aging
- Keywords
- blood flow restriction, cardiovagal modulation, resistance exercise, young adults, older adults, recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 14 May 2027 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel group crossover randomized trial
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity + Blood Flow Restriction | Experimental | Other: Low-Intensity Resistance Training with Blood Flow Restriction (LIRT-BFR) |
| High-Intensity Resistance Training (HIRT) | Active comparator | Other: High-Intensity Resistance Training (HIRT) |
| No exercise or blood flow restriction | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | High-Intensity Resistance Training (HIRT) |
| Low-Intensity Resistance Training with Blood Flow Restriction (LIRT-BFR)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. | Other | Low-Intensity + Blood Flow Restriction |
Primary outcome
Changes in Time-Domain Heart Rate Variability Indices
Time frame: 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.
4 secondary outcomes
Changes in Frequency-Domain Heart Rate Variability Indices
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- BackgroundOliveira 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.
- Background: PubMed 34789148Grassler 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.
- Background: PubMed 24077384Okuno 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.
- BackgroundGanzarolli 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
- Background: PubMed 28029066Ferreira 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Resistance Training (HIRT) and Low-Intensity Resistance Training with Blood Flow Restriction (LIRT-BFR) in people with Blood Flow Restriction Exercise and Aging, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier Melo, PhD (+351 212946700, xmelo@egasmoniz.edu.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Time-Domain Heart Rate Variability Indices (time frame: Baseline (15-minute seated rest); during exercise (continuous throughout the 30-minute exercise bout); and 30 minutes into recovery (seated position)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07722403, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.