NCT07497659

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Keywords

blood pressureischemic preconditioningmenopauseresistance exercise

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 minutes post-exercise

Secondary Outcomes (5)

  • Systolic blood pressure

    20 minutes post-exercise

  • Mean arterial pressure

    20 minutes post-exercise

  • Diastolic blood pressure

    20 minutes post-exercise

  • Heart rate

    20 minutes post-exercise

  • Heart Rate Recovery (HRR60)

    60 seconds post-exercise

Study Arms (2)

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.

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.

Device: Sham Preconditioning

Interventions

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.

Ischemic Preconditioning (IPC)

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.

SHAM

Eligibility Criteria

Age60 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants are eligible for this study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Triângulo Mineiro (UFTM)

Uberaba, Minas Gerais, +55, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 25956401BACKGROUND
  • 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.

    PMID: 31813045BACKGROUND
  • 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.

    PMID: 19516148BACKGROUND
  • 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.

    PMID: 23175179BACKGROUND

MeSH Terms

Interventions

Ischemic Preconditioning

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Gustavo Mota, PhD

    Federal University of Triângulo Mineiro (UFTM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor (PhD)

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

May 28, 2025

Primary Completion

September 18, 2025

Study Completion

September 18, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy and confidentiality considerations. The dataset is small and may allow participant identification.

Locations