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Completed

NCT Number: NCT07497659

Ischemic Preconditioning in Resistance Exercise in Older Women

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.

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Key information

Age range

60 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Triângulo Mineiro (UFTM)

Uberaba, Minas Gerais, +55, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • - 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

Treatment and study plan

Ischemic Preconditioning

Device

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 Preconditioning

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Systolic blood pressure

    Time frame: 20 minutes post-exercise

    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.

  2. Mean arterial pressure

    Time frame: 20 minutes post-exercise

    Mean arterial pressure will be calculated as diastolic blood pressure plus one-third of pulse pressure.

  3. Diastolic blood pressure

    Time frame: 20 minutes post-exercise

    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.

  4. Heart rate

    Time frame: 20 minutes post-exercise

    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.

  5. Heart Rate Recovery (HRR60)

    Time frame: 60 seconds post-exercise

    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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Triangulo Mineiro

Other

Registry information

Official study title

Ischemic Preconditioning and Cardiac Demand During Resistance Exercise in Older Women: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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