Blood PressureNCT07497659
Ischemic Preconditioning in Resistance Exercise in Older Women
A study testing Ischemic Preconditioning in people with Blood Pressure and Hemodynamic Response, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.
Trial summary
This study investigates whether ischemic preconditioning (IPC) can reduce cardiac demand after resistance exercise in older women. Aging is associated with increased cardiovascular stress, especially due to elevated blood pressure and cardiac demand during and after exercise. Read more about this study
- Who is it for?
- Ages 60 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hemodynamic Response, Rating of Perceived Exertion
- What is being tested?
- Ischemic Preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 28 May 2025to 18 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants aged 60 years or older
- Physically independent
- Engaged in regular physical activity (at least two sessions per week for the last three months)
- Cleared for exercise participation by a cardiologist following clinical evaluation
- Able to safely perform resistance exercise
- Provided written informed consent
Who cannot join
- - History of cardiovascular events such as myocardial infarction or stroke
- Uncontrolled hypertension (≥160/105 mmHg)
- Diabetes mellitus
- Current smoking or alcohol abuse
- Musculoskeletal limitations that impair exercise performance
- Cognitive or communication impairments that interfere with understanding instructions
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Triângulo Mineiro (UFTM)
Uberaba, Minas Gerais, +55
About this study
Official title: Ischemic Preconditioning and Cardiac Demand During Resistance Exercise in Older Women: A Randomized Clinical Trial
This study investigates whether ischemic preconditioning (IPC) can reduce cardiac demand after resistance exercise in older women.
Aging is associated with increased cardiovascular stress, especially due to elevated blood pressure and cardiac demand during and after exercise. Strategies that can reduce this overload may improve exercise safety in older women.
Read more
This is a randomized, single-blind, crossover clinical trial involving 30 women aged 60 years or older. Participants perform two conditions: ischemic preconditioning (IPC) and a sham condition (SHAM), followed by a standardized resistance exercise session.
The primary outcome is cardiac workload, assessed by the rate-pressure product (systolic blood pressure × heart rate) during post-exercise recovery. Secondary outcomes include blood pressure, heart rate, and heart rate recovery.
The results of this study may contribute to safer exercise strategies for older women.
Read the detailed description
Aging is associated with significant cardiovascular alterations, including increased arterial stiffness, impaired endothelial function, and elevated cardiac workload during and after physical exercise. In older women, these changes are exacerbated by postmenopausal hormonal decline, increasing vulnerability to cardiovascular stress.
Resistance exercise is recommended to improve strength, functional capacity, and overall health in older adults. However, it may induce acute increases in blood pressure and myocardial workload, particularly in individuals with reduced vascular compliance and impaired autonomic regulation. These responses may persist into the recovery period, increasing cardiovascular risk.
Ischemic preconditioning (IPC) is a non-pharmacological intervention that involves repeated cycles of vascular occlusion and reperfusion. This procedure can promote vascular adaptations, including increased nitric oxide bioavailability, improved endothelial function, and reduced peripheral vascular resistance. These mechanisms may contribute to attenuating hemodynamic stress during and after exercise.
Although IPC has shown promising results in young adults and clinical populations, there is limited evidence regarding its effects on hemodynamic responses following resistance exercise in older women.
This study is designed as a randomized, single-blind, crossover clinical trial including 30 physically independent women aged 60 years or older. Participants will complete two experimental conditions in randomized order: ischemic preconditioning (IPC) and a sham condition (SHAM).
The IPC protocol consists of three cycles of 3 minutes of arterial occlusion at a pressure 50 mmHg above systolic blood pressure, interspersed with 3 minutes of reperfusion. The sham condition consists of the same procedure with a fixed low pressure (20 mmHg), insufficient to induce arterial occlusion.
After each intervention, participants will perform a standardized resistance exercise session composed of four exercises: horizontal row, bench press, leg extension, and 45-degree leg press. The intensity will be set at 80% of 10-repetition maximum, with three sets of 10 repetitions per exercise and standardized rest intervals.
Hemodynamic variables will be assessed at rest, after the intervention, during exercise, and during recovery. The primary outcome is cardiac workload, assessed by the rate-pressure product, measured 20 minutes after exercise.
Secondary outcomes include systolic, diastolic, and mean arterial blood pressure, heart rate, and heart rate recovery at 60 seconds. Perceptual variables will be used to ensure similar baseline conditions between sessions.
Statistical analysis will be performed using linear mixed models, including condition, period, and sequence as fixed effects, with baseline values as covariates and random intercepts for participants.
- Being tested
- Ischemic Preconditioning, Sham Preconditioning
- Keywords
- blood pressure, ischemic preconditioning, menopause, resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic PreconditioningDevice
Ischemic preconditioning consists of three cycles of 3 minutes of arterial occlusion at a pressure 50 mmHg above systolic blood pressure, interspersed with 3 minutes of reperfusion. The procedure is applied using a blood pressure cuff positioned on the proximal thighs in an alternating unilateral manner, where one limb undergoes occlusion while the contralateral limb remains in reperfusion. The intervention is performed prior to a standardized resistance exercise session.
Sham PreconditioningDevice
The sham condition consists of the same procedure and timing as the ischemic preconditioning protocol, using a blood pressure cuff applied to the proximal thighs in an alternating unilateral manner. However, a fixed pressure of 20 mmHg is applied, which is insufficient to induce arterial occlusion. The procedure is performed prior to a standardized resistance exercise session.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Preconditioning (IPC) | Experimental | Participants undergo ischemic preconditioning applied with one blood pressure cuff positioned on the proximal region of the thighs in an alternating unilateral manner. The protocol consists of three cycles of 3 minutes of arterial occlusion at a pressure 50 mmHg above systolic blood pressure, interspersed with 3 minutes of reperfusion. While one thigh receives occlusion, the contralateral thigh remains in reperfusion, alternating throughout the protocol. The procedure is performed before a standardized resistance exercise session. Receives: Device: Ischemic Preconditioning |
| SHAM | Sham comparator | Participants undergo a sham procedure using one blood pressure cuff applied to the proximal thighs in an alternating unilateral manner. The protocol follows the same timing and alternation pattern as the ischemic preconditioning condition, but with a fixed pressure of 20 mmHg, which is insufficient to produce arterial occlusion. The procedure is performed before a standardized resistance exercise session. Receives: Device: Sham Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac workload (rate-pressure product)
Cardiac workload will be assessed by the rate-pressure product (RPP), calculated as systolic blood pressure multiplied by heart rate. This measure represents an indirect index of myocardial oxygen demand and cardiac stress.
Measured: 20 minutes post-exercise
Secondary outcomes (5)
Systolic blood pressure
Systolic blood pressure will be measured during post-exercise recovery. This variable is also used to calculate the rate-pressure product, the primary outcome of the study.
Measured: 20 minutes post-exercise
Mean arterial pressure
Mean arterial pressure will be calculated as diastolic blood pressure plus one-third of pulse pressure.
Measured: 20 minutes post-exercise
Diastolic blood pressure
Diastolic blood pressure will be measured during post-exercise recovery under both ischemic preconditioning (IPC) and sham conditions. This variable reflects peripheral vascular resistance and contributes to the characterization of hemodynamic responses following resistance exercise. Diastolic blood pressure will also be considered alongside systolic blood pressure for the calculation of mean arterial pressure.
Measured: 20 minutes post-exercise
Heart rate
Heart rate will be measured during post-exercise recovery under both ischemic preconditioning (IPC) and sham conditions. This variable reflects cardiac chronotropic response and contributes to the assessment of cardiovascular load following resistance exercise. Heart rate will also be used in combination with systolic blood pressure to calculate the rate-pressure product, the primary outcome of the study.
Measured: 20 minutes post-exercise
Heart Rate Recovery (HRR60)
Heart rate recovery will be defined as the difference between peak heart rate at the end of exercise and heart rate at 60 seconds of recovery under both ischemic preconditioning (IPC) and sham conditions. This variable reflects autonomic regulation, particularly parasympathetic reactivation following exercise, and is considered an important indicator of cardiovascular function and recovery capacity.
Measured: 60 seconds post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start28 May 2025
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Triangulo Mineiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Ribeiro da Mota, Universidade Federal do Triangulo Mineiro
- Investigators
- Gustavo Mota, PhD, Principal investigator, Federal University of Triângulo Mineiro (UFTM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497659
- Sponsor's protocol ID
- 33413214.1.0000.5154
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations. The dataset is small and may allow participant identification.
Publications
Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6.
PubMed 25956401Mota GR, Rightmire ZB, Martin JS, McDonald JR, Kavazis AN, Pascoe DD, Gladden LB. Ischemic preconditioning has no effect on maximal arm cycling exercise in women. Eur J Appl Physiol. 2020 Feb;120(2):369-380. doi: 10.1007/s00421-019-04281-9. Epub 2019 Dec 7.
PubMed 31813045American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
PubMed 19516148Queiroz AC, Kanegusuku H, Chehuen MR, Costa LA, Wallerstein LF, Dias da Silva VJ, Mello MT, Ugrinowitsch C, Forjaz CL. Cardiac work remains high after strength exercise in elderly. Int J Sports Med. 2013 May;34(5):391-7. doi: 10.1055/s-0032-1323779. Epub 2012 Nov 22.
PubMed 23175179
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Preconditioning and Cardiac Demand During Resistance Exercise in Older Women: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07497659
- Acronym / sponsor ID
- 33413214.1.0000.5154
- Keywords
- blood pressure, ischemic preconditioning, menopause, resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal do Triangulo MineiroUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 27 Mar 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.
This study investigates whether ischemic preconditioning (IPC) can reduce cardiac demand after resistance exercise in older women.
Aging is associated with increased cardiovascular stress, especially due to elevated blood pressure and cardiac demand during and after exercise. Strategies that can reduce this overload may improve exercise safety in older women.
This is a randomized, single-blind, crossover clinical trial involving 30 women aged 60 years or older. Participants perform two conditions: ischemic preconditioning (IPC) and a sham condition (SHAM), followed by a standardized resistance exercise session.
The primary outcome is cardiac workload, assessed by the rate-pressure product (systolic blood pressure × heart rate) during post-exercise recovery. Secondary outcomes include blood pressure, heart rate, and heart rate recovery.
The results of this study may contribute to safer exercise strategies for older women.
Detailed description
Aging is associated with significant cardiovascular alterations, including increased arterial stiffness, impaired endothelial function, and elevated cardiac workload during and after physical exercise. In older women, these changes are exacerbated by postmenopausal hormonal decline, increasing vulnerability to cardiovascular stress.
Resistance exercise is recommended to improve strength, functional capacity, and overall health in older adults. However, it may induce acute increases in blood pressure and myocardial workload, particularly in individuals with reduced vascular compliance and impaired autonomic regulation. These responses may persist into the recovery period, increasing cardiovascular risk.
Ischemic preconditioning (IPC) is a non-pharmacological intervention that involves repeated cycles of vascular occlusion and reperfusion. This procedure can promote vascular adaptations, including increased nitric oxide bioavailability, improved endothelial function, and reduced peripheral vascular resistance. These mechanisms may contribute to attenuating hemodynamic stress during and after exercise.
Although IPC has shown promising results in young adults and clinical populations, there is limited evidence regarding its effects on hemodynamic responses following resistance exercise in older women.
This study is designed as a randomized, single-blind, crossover clinical trial including 30 physically independent women aged 60 years or older. Participants will complete two experimental conditions in randomized order: ischemic preconditioning (IPC) and a sham condition (SHAM).
The IPC protocol consists of three cycles of 3 minutes of arterial occlusion at a pressure 50 mmHg above systolic blood pressure, interspersed with 3 minutes of reperfusion. The sham condition consists of the same procedure with a fixed low pressure (20 mmHg), insufficient to induce arterial occlusion.
After each intervention, participants will perform a standardized resistance exercise session composed of four exercises: horizontal row, bench press, leg extension, and 45-degree leg press. The intensity will be set at 80% of 10-repetition maximum, with three sets of 10 repetitions per exercise and standardized rest intervals.
Hemodynamic variables will be assessed at rest, after the intervention, during exercise, and during recovery. The primary outcome is cardiac workload, assessed by the rate-pressure product, measured 20 minutes after exercise.
Secondary outcomes include systolic, diastolic, and mean arterial blood pressure, heart rate, and heart rate recovery at 60 seconds. Perceptual variables will be used to ensure similar baseline conditions between sessions.
Statistical analysis will be performed using linear mixed models, including condition, period, and sequence as fixed effects, with baseline values as covariates and random intercepts for participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Preconditioning (IPC) | Experimental | Device: Ischemic PreconditioningParticipants undergo ischemic preconditioning applied with one blood pressure cuff positioned on the proximal region of the thighs in an alternating unilateral manner. The protocol consists of three cycles of 3 minutes of arterial occlusion at a pressure 50 mmHg above systolic blood pressure, interspersed with 3 minutes of reperfusion. While one thigh receives occlusion, the contralateral thigh remains in reperfusion, alternating throughout the protocol. The procedure is performed before a standardized resistance exercise session. |
| SHAM | Sham comparator | Device: Sham PreconditioningParticipants undergo a sham procedure using one blood pressure cuff applied to the proximal thighs in an alternating unilateral manner. The protocol follows the same timing and alternation pattern as the ischemic preconditioning condition, but with a fixed pressure of 20 mmHg, which is insufficient to produce arterial occlusion. The procedure is performed before a standardized resistance exercise session. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female participants aged 60 years or older
- Physically independent
- Engaged in regular physical activity (at least two sessions per week for the last three months)
- Cleared for exercise participation by a cardiologist following clinical evaluation
- Able to safely perform resistance exercise
Key exclusion criteria (6 listed)
- - History of cardiovascular events such as myocardial infarction or stroke
- Uncontrolled hypertension (≥160/105 mmHg)
- Diabetes mellitus
- Current smoking or alcohol abuse
- Musculoskeletal limitations that impair exercise performance
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 |
|---|---|---|
| Ischemic PreconditioningIschemic preconditioning consists of three cycles of 3 minutes of arterial occlusion at a pressure 50 mmHg above systolic blood pressure, interspersed with 3 minutes of reperfusion. The procedure is applied using a blood pressure cuff positioned on the proximal thighs in an alternating unilateral manner, where one limb undergoes occlusion while the contralateral limb remains in reperfusion. The intervention is performed prior to a standardized resistance exercise session. | Device | Ischemic Preconditioning (IPC) |
| Sham PreconditioningThe sham condition consists of the same procedure and timing as the ischemic preconditioning protocol, using a blood pressure cuff applied to the proximal thighs in an alternating unilateral manner. However, a fixed pressure of 20 mmHg is applied, which is insufficient to induce arterial occlusion. The procedure is performed prior to a standardized resistance exercise session. | Device | SHAM |
Primary outcome
Cardiac workload (rate-pressure product)
Time frame: 20 minutes post-exercise
Cardiac workload will be assessed by the rate-pressure product (RPP), calculated as systolic blood pressure multiplied by heart rate. This measure represents an indirect index of myocardial oxygen demand and cardiac stress.
5 secondary outcomes
Systolic blood pressure
Time frame: 20 minutes post-exercise
Mean arterial pressure
Time frame: 20 minutes post-exercise
Diastolic blood pressure
Time frame: 20 minutes post-exercise
Heart rate
Time frame: 20 minutes post-exercise
Heart Rate Recovery (HRR60)
Time frame: 60 seconds post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 25956401Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6.
- Background: PubMed 31813045Mota GR, Rightmire ZB, Martin JS, McDonald JR, Kavazis AN, Pascoe DD, Gladden LB. Ischemic preconditioning has no effect on maximal arm cycling exercise in women. Eur J Appl Physiol. 2020 Feb;120(2):369-380. doi: 10.1007/s00421-019-04281-9. Epub 2019 Dec 7.
- Background: PubMed 19516148American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
- Background: PubMed 23175179Queiroz AC, Kanegusuku H, Chehuen MR, Costa LA, Wallerstein LF, Dias da Silva VJ, Mello MT, Ugrinowitsch C, Forjaz CL. Cardiac work remains high after strength exercise in elderly. Int J Sports Med. 2013 May;34(5):391-7. doi: 10.1055/s-0032-1323779. Epub 2012 Nov 22.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations. The dataset is small and may allow participant identification.
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
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. This study is not recruiting at the moment.
Gustavo Mota, PhD principal investigator
Federal University of Triângulo Mineiro (UFTM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Preconditioning in people with Blood Pressure and Hemodynamic Response, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 27 Mar 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac workload (rate-pressure product) (time frame: 20 minutes post-exercise). 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 NCT07497659, which also lists 4 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 27 Mar 2026.