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Recruiting INTERVENTIONAL NCT03663777

Handgrip Training in Patients With Peripheral Artery Disease (Isopress_03)

Effects of 12 Weeks of Isometric Handgrip Training in Blood Pressure in Patients With Peripheral Artery Disease

Sponsor: Hospital Israelita Albert Einstein

Updated 10 times since 2018 Last updated: Apr 27, 2026 Started: Aug 1, 2018 Primary completion: Dec 30, 2027 Completion: Dec 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Peripheral Arterial Disease and is currently actively recruiting participants. Hospital Israelita Albert Einstein leads this study, which shows 10 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

Meta-analyze studies have shown that 4 sets of 2 min of isometric handgrip training (IHT)reduces blood pressure (BP), reaching 10 mmHg for systolic and diastolic 7 mmHg in hypertensive patients after few weeks. However, using this protocol it was not observed any changes in BP in patients with peripheral artery disease. However, it is unknown whether reductions in BP does not occur after isometric handgrip training employing longer and protocol of IHT with more volume. The aim of this study is to analyze the effects of IHT on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients, which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will hold three sessions per week with eight sets of two minutes of isometric contraction at 30% of maximal voluntary contraction and interval of two minutes between them, for 12 weeks. In the CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, BP and cardiac autonomic modulationwill be assessed. Will be used to analyze two-factor variance for repeated measures, with group (IHT and CG) and the time (before and after 12 weeks) as...

Meta-analyze studies have shown that 4 sets of 2 min of isometric handgrip training (IHT)reduces blood pressure (BP), reaching 10 mmHg for systolic and diastolic 7 mmHg in hypertensive patients after few weeks. However, using this protocol it was not observed any changes in BP in patients with peripheral artery disease. However, it is unknown whether reductions in BP does not occur after isometric handgrip training employing longer and protocol of IHT with more volume. The aim of this study is to analyze the effects of IHT on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients, which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will hold three sessions per week with eight sets of two minutes of isometric contraction at 30% of maximal voluntary contraction and interval of two minutes between them, for 12 weeks. In the CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, BP and cardiac autonomic modulationwill be assessed. Will be used to analyze two-factor variance for repeated measures, with group (IHT and CG) and the time (before and after 12 weeks) as factors and the post-hoc test of Newman-Keuls.

Status Flow

~Oct 2018 – ~Oct 2020 · 24 months · monthly snapshotRecruiting~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshotUnknown Status~Jan 2021 – ~Nov 2021 · 10 months · monthly snapshotUnknown Status~Nov 2021 – ~Nov 2022 · 12 months · monthly snapshotSuspended~Nov 2022 – ~Nov 2023 · 12 months · monthly snapshotRecruiting~Nov 2023 – ~Jun 2024 · 7 months · monthly snapshotRecruiting~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~May 2026 · 20 months · monthly snapshotRecruitingMay 4, 2026 – present · 2 months · daily APIRecruiting

Change History

10 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: NANone

  2. Sep 2024 — May 2026 [monthly]

    Recruiting NA

  3. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  4. Jun 2024 — Jul 2024 [monthly]

    Recruiting NA

  5. Nov 2023 — Jun 2024 [monthly]

    Recruiting NA

Show 5 earlier versions
  1. Nov 2022 — Nov 2023 [monthly]

    Recruiting NA

    Status: SuspendedRecruiting

  2. Nov 2021 — Nov 2022 [monthly]

    Suspended NA

    Status: Unknown StatusSuspended

  3. Jan 2021 — Nov 2021 [monthly]

    Unknown Status NA

  4. Oct 2020 — Jan 2021 [monthly]

    Unknown Status NA

    Status: RecruitingUnknown Status

  5. Oct 2018 — Oct 2020 [monthly]

    Recruiting NA

    First recorded

Aug 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will training isometric contraction for 12 weeks. In CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention cardiovascular measures will be obtained.

Contact Information

Sponsor contact:
  • Hospital Israelita Albert Einstein
  • University of Nove de Julho
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .