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NCT Number: NCT06454487

Exploring IHG Training in CR

Research has shown that isometric (constant squeeze) exercise training using an isometric handgrip (IHG) device lowers resting blood pressure (BP) in those with and without high BP. The purpose of this study is to explore if IHG training will lower resting BP in people doing cardiac rehabilitation more than doing only cardiac rehabilitation. Once eligibility is confirmed participants will be randomly assigned to one of two groups for the study. One group will do IHG training in addition to cardiac rehabilitation (Group 1), and the other group will do only cardiac rehabilitation (Group 2). Participants assigned to Group 1 will be asked to do IHG training on their own with an inflatable ball three days per week for 12 weeks with intensity set based on rating of perceived exertion (RPE) or rating of effort. Participants will self-measure and report their resting BP to investigators. The acceptability of doing IHG training will also be explored by conducting interviews with participants as will the impact that IHG training may have on psychological wellbeing by administering surveys to participants.

Why the study stopped: Study not initiated
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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Joseph's Hospital Cardiac Rehabilitation and Secondary Prevention, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Component adult (greater ≥ 18 years) who can provide informed consent.
  • Proficient in English (speaking, writing, and reading).
  • Medically cleared by the cardiac rehabilitation program to participate in exercise-based cardiac rehabilitation.
  • History of only coronary artery disease, the most common cardiovascular disease (CVD), which may include individuals with a previous myocardial infarction and/or procedure such as a percutaneous coronary intervention and/or coronary artery bypass grafting.
  • Minimum of "blue" level of technology capability (assigned by the cardiac rehabilitation program) indicating ability to use a phone and email for correspondence. Note: The majority of individuals who enroll in the cardiac rehabilitation program are assigned to this level.
  • No physical limitation(s) that would hinder the performance of isometric handgrip training.
  • Access to a blood pressure monitoring device to record at home measures.

Exclusion criteria

  • If the participant does not meet the inclusion criteria (identified above).
  • Moreover if an individual has a history of a CVD or disease-related complications (e.g., heart failure, atrial fibrillation, ventricular arrhythmias, aortic aneurysm, valve repair and/or replacement) and/or related procedures (e.g., placement of a pacemaker and/or implantable cardiac defibrillator) that is not coronary artery disease (as described in the inclusion criteria) they will be excluded.

Note: Individuals may have other comorbidities.

Treatment and study plan

Isometric Hand Grip Training

Other

IHG training will be performed with an inflatable ball three days per week for 12 weeks (with at least a day of rest between each session) with intensity set based on RPE (Borg CR-10 scale).

Other names: IHG

CR

Other

Standard of Care

Other names: Cardiac Rehabilitation

Primary outcomes

  1. Reduction in Resting Blood Pressure

    Time frame: 12 weeks

    Self report of Resting Blood Pressure at baseline vs week 5, 9 and post-intervention

Secondary outcomes

  1. User Experience of IHG

    Time frame: 12 weeks

    Qualitative content analysis (participant interviews)

  2. Psychological state

    Time frame: 12 weeks

    Self-report of depression, anxiety, stress, and mindfulness using participant surveys

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Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • University of Windsor

Registry information

Official study title

Investigating the Effectiveness and Acceptability of Isometric Handgrip Training in Remote Cardiac Rehabilitation Patients: A Randomized Controlled Trial With an Embedded Qualitative Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 12, 2024
Registry last updated
Sep 17, 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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