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Heart device study tests virtual workouts for Women's health

NCT ID NCT05946304

Symptom relief Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a 12-week virtual exercise program could help women with cardiac implantable electronic devices (CIEDs) improve their physical fitness, quality of life, and mental health. Twenty women took part, doing either high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT) from home. The goal was to see if the program was feasible and beneficial for this group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Nov 2023

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Women (i.e., female sex assigned at birth) with CIED (≥6 months since implant) 2. Women with CIED in optimal medical therapy and functioning; 3. Patient is able to perform a symptom-limited CPET; 4. Patient is able to read and understand English or French. Exclusion Criteria: 1. Patient is currently participating in routine exercise training (\>2x/week); 2. Patient has: documented unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy; 3. Patient has an unmanaged psychiatric illness (e.g., active psychosis, suicidal ideation) or cognitive impairment; 4. Patient does not have an internet connection or a device with a camera and speakers; 5. Patient with any device troubleshooting at resting or during exercise; 6. Patient is unable to provide written informed consent; 7. Patient is unwilling or unable to return for follow-up visits at week 12; 8. Patient is unwilling to be randomized to HIIT or MICT; or 9. Pregnancy or patients who become pregnant during the 12-week intervention phase (the effects of interval training on an unborn fetus are unknown).

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease cardiovascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases

Contacts and locations

Locations

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7, Canada

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