Exploring IHG Training in CR

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06454487
• Other study ID #: ReDA13269
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: June 2024
• Source: Lawson Health Research Institute
• Contact: Cheri McGowan, PhD
• Phone: 519-253-3000
• Email: mcgowanc[@]uwindsor.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Cardiac Rehabilitation

Intervention

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).
• CR
Standard of Care

Locations

Country	Name	City	State
Canada	St Joseph's Hospital Cardiac Rehabilitation and Secondary Prevention	London	Ontario
Canada	Hotel Dieu Grace Cardiac Rehabilitation	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	University of Windsor

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Resting Blood Pressure	Self report of Resting Blood Pressure at baseline vs week 5, 9 and post-intervention	12 weeks
Secondary	User Experience of IHG	Qualitative content analysis (participant interviews)	12 weeks
Secondary	Psychological state	Self-report of depression, anxiety, stress, and mindfulness using participant surveys	12 weeks