- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07497659
Ischemic Preconditioning in Resistance Exercise in Older Women
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.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minas Gerais
-
Uberaba, Minas Gerais, Brazil, +55
- Federal University of Triângulo Mineiro (UFTM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ischemic Preconditioning (IPC)
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.
|
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 Comparator: SHAM
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
20 minutes post-exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
20 minutes post-exercise
|
|
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.
|
20 minutes post-exercise
|
|
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.
|
20 minutes post-exercise
|
|
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.
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20 minutes post-exercise
|
|
Heart Rate Recovery (HRR60)
Time Frame: 60 seconds post-exercise
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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.
|
60 seconds post-exercise
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gustavo Mota, PhD, Federal University of Triângulo Mineiro (UFTM)
Publications and helpful links
General Publications
- American 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.
- 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.
- Mota 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.
- Queiroz 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33413214.1.0000.5154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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