Exploring IHG Training in CR

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure; Cardiac Rehabilitation
• Intervention / Treatment: Other: Isometric Hand Grip Training; Other: CR

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheri McGowan, PhD; Phone Number: 2451 519-253-3000; Email: mcgowanc@uwindsor.ca
• Study Contact Backup: Name: Tim Hartley, MSc; Phone Number: 36570 519-646-6100; Email: tim.hartley@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St Joseph's Hospital Cardiac Rehabilitation and Secondary Prevention
      • Contact: Tim Hartley, MSc; Phone Number: 36570 519-646-6100; Email: tim.hartley@lhsc.on.ca
      • Contact: Cayla Wood, MSc; Email: wood1x@uwindsor.ca
    • Windsor, Ontario, Canada
      • Hotel Dieu Grace Cardiac Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CR+IHG; Cardiac Rehabilitation (usual care) PLUS Isometric Hand grip training	Other: Isometric Hand Grip Training; 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
Active Comparator: CR; Cardiac Rehabilitation (usual care) Only	Other: CR; Standard of Care; Other Names: Cardiac Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Resting Blood Pressure	Self report of Resting Blood Pressure at baseline vs week 5, 9 and post-intervention	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Experience of IHG	Qualitative content analysis (participant interviews)	12 weeks
Psychological state	Self-report of depression, anxiety, stress, and mindfulness using participant surveys	12 weeks

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: University of Windsor
• Investigators: Principal Investigator: Cheri McGowan, PhD, Windsor University and LawsonHRI

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Blood Pressure; Cardiac Rehabilitation; Hand Grip Training
• Other Study ID Numbers: ReDA13269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No