Clinical trial NCT06454487: Exploring IHG Training in CR
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Blood Pressure
Keywords: Cardiac Rehabilitation
Hand Grip Training
Blood Pressure
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Windsor
First posted: 2024-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in Resting Blood Pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: User Experience of IHG
timeFrame: 12 weeks
measure: Psychological state
timeFrame: 12 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: St Joseph's Hospital Cardiac Rehabilitation and Secondary Prevention
state: Ontario
city: Windsor
country: Canada
facility: Hotel Dieu Grace Cardiac Rehabilitation
state: Ontario
Study officials:
affiliation: Windsor University and LawsonHRI
name: Cheri McGowan, PhD
role: PRINCIPAL_INVESTIGATOR
References: