Cardiac RehabilitationNCT06454487
Exploring IHG Training in CR
A study testing Isometric Hand Grip Training and CR in people with Cardiac Rehabilitation and Blood Pressure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Blood Pressure
- What is being tested?
- Isometric Hand Grip Training and CR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St Joseph's Hospital Cardiac Rehabilitation and Secondary Prevention
London, Ontario, N6A 4V2
Hotel Dieu Grace Cardiac Rehabilitation
Windsor, Ontario
About this study
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
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
- Being tested
- Isometric Hand Grip Training, CR
- Keywords
- Cardiac Rehabilitation, Hand Grip Training, Blood Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Hand Grip TrainingOther
Also called IHG
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).
CROther
Also called Cardiac Rehabilitation
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| CR+IHG | Experimental | Cardiac Rehabilitation (usual care) PLUS Isometric Hand grip training Receives: Other: Isometric Hand Grip Training |
| CR | Active comparator | Cardiac Rehabilitation (usual care) Only Receives: Other: CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Resting Blood Pressure
Self report of Resting Blood Pressure at baseline vs week 5, 9 and post-intervention
Measured: 12 weeks
Secondary outcomes (2)
User Experience of IHG
Qualitative content analysis (participant interviews)
Measured: 12 weeks
Psychological state
Self-report of depression, anxiety, stress, and mindfulness using participant surveys
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study startJul 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Why it stopped: Study not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Windsor
- Responsible party
- Sponsor
- Investigators
- Cheri McGowan, PhD, Principal investigator, Windsor University and LawsonHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454487
- Sponsor's protocol ID
- ReDA13269
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06454487
- Acronym / sponsor ID
- ReDA13269
- Conditions
- Cardiac Rehabilitation, Blood Pressure
- Keywords
- Cardiac Rehabilitation, Hand Grip Training, Blood Pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Windsor
- Study start
- Jul 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CR+IHG | Experimental | Other: Isometric Hand Grip TrainingCardiac Rehabilitation (usual care) PLUS Isometric Hand grip training |
| CR | Active comparator | Other: CRCardiac Rehabilitation (usual care) Only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric Hand Grip TrainingAlso: IHGIHG 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 | CR+IHG |
| CRAlso: Cardiac RehabilitationStandard of Care | Other | CR |
Primary outcome
Reduction in Resting Blood Pressure
Time frame: 12 weeks
Self report of Resting Blood Pressure at baseline vs week 5, 9 and post-intervention
2 secondary outcomes
User Experience of IHG
Time frame: 12 weeks
Psychological state
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Cardiac Rehabilitation
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Recruiting
Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
Heart Failure, Ventricular Function, Left
Recruiting
Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
Not yet recruiting
Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation
Cardiovascular Diseases (CVD)
Recruiting
Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair
Abdominal Aortic Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheri McGowan, PhD principal investigator
Windsor University and LawsonHRI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Hand Grip Training and CR in people with Cardiac Rehabilitation and Blood Pressure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Resting Blood Pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.