Exploring IHG Training in CR

NCT06454487 | Not Yet Recruiting

• 1 other identifier: ReDA13269
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Rehabilitation; Blood Pressure

Keywords

Cardiac Rehabilitation; Hand Grip Training; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Reduction in Resting Blood Pressure

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

  12 weeks

Secondary Outcomes (2)

• User Experience of IHG

  12 weeks

• Psychological state

  12 weeks

Study Arms (2)

CR+IHG

EXPERIMENTAL

Cardiac Rehabilitation (usual care) PLUS Isometric Hand grip training

Other: Isometric Hand Grip Training

CR

ACTIVE COMPARATOR

Cardiac Rehabilitation (usual care) Only

Other: CR

Interventions

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).

Also known as: IHG

CR+IHG

CR OTHER

Standard of Care

Also known as: Cardiac Rehabilitation

CR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Note: Individuals may have other comorbidities.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Windsor: collaborator

Study Sites (2)

St Joseph's Hospital Cardiac Rehabilitation and Secondary Prevention

London, Ontario, N6A 4V2, Canada

Location

Hotel Dieu Grace Cardiac Rehabilitation

Windsor, Ontario, Canada

Location

MeSH Terms

Interventions

Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cheri McGowan, PhD

  Windsor University and LawsonHRI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheri McGowan, PhD

CONTACT

519-253-3000; mcgowanc@uwindsor.ca

Tim Hartley, MSc

CONTACT

519-646-6100; tim.hartley@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: March 30, 2025
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)