Exercise Training in Women With Cardiac Devices (CIED-EX)

March 11, 2026 updated by: Ottawa Heart Institute Research Corporation

The Effects of Exercise Training on Physical and Mental Health in Women With Cardiac Implantable Electronic Devices (CIED-EX): a Pilot Study

Cardiac implantable electronic devices (CIED) are established treatments for a variety of cardiac arrhythmias. Women with CIED have lower fitness and lower quality of life compared to men with CIED. Moderate-intensity continuous training (MICT) is the most prescribed exercise for women. However, high-intensity interval training (HIIT) has been shown to improve fitness, anxiety levels, quality of life, and other health indicators over MICT in men with CIED. There is a need to quantitatively evaluate the feasibility and effects of a virtual HIIT vs. virtual MICT program on the physical, quality of life, and mental health of women with CIED. Furthermore, a qualitative approach is also necessary to understand patients' experiences, barriers, and facilitators of a virtual exercise intervention. This mixed-methods pilot randomized controlled trial will assess the feasibility of a 12-week virtual HIIT and MICT program in women with CIED.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Standard care + moderate-intensity continuous exercise training (MICT)
Supervised virtual MICT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.
Behavioral: moderate-intensity continuous exercise training (MICT) group
Exercise session: Warm-up: 60-70% peak heart rate (HR) - 10min; Training: 70-85% peak HR - 35min; Cool-down: 60-70% peak HR - 15min.
Experimental: Standard care + high-intensity interval training (HIIT)
Supervised virtual HIIT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.
Behavioral: high-intensity interval training (HIIT) group
Warm-up: 60-70% peak heart rate (HR) - 10min; Training: 85-95% peak HR - 25 minutes (4x4-minutes of high-intensity intervals interspersed with 3 minutes of low-intensity intervals); Cool-down: 60-70% peak HR - 10min.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility - Number of classes participants attended
Time Frame: Week 12
Exercise attendance will be assessed by the number of classes participants attended. High attendance to the CR program will be defined as being present at ≥ 70% of the classes.
Week 12
Feasibility - Compliance to the exercise prescription based on heart rate
Time Frame: Week 12
Exercise compliance will be assessed as the ability to complete the prescribed intensity (based on the heart rate peak [HR] of the cardiopulmonary exercise test) for high-intensity interval training or moderate-intensity continuous training. The HRs across all classes for each patient will be averaged and compared to their target HR prescription. For instance, where patients exercised below, within, or above the prescribed HR ranges, these will be coded as "does not comply", "complies" and "exceeds".
Week 12
Feasibility - Adverse events
Time Frame: Week 12
Safety will be assessed by enumerating reported adverse events during the study period.
Week 12
Feasibility - Number of dropouts
Time Frame: Week 12
The number of patients who withdraw from the program will be reported as descriptive data and compared between groups (e.g., high-intensity interval program vs moderate-intensity continuous training).
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise capacity - maximal oxygen uptake (VO2peak)
Time Frame: Baseline
will be measured using a gold standard symptom-limited, cardiopulmonary exercise test (CPET) on an electronically braked cycle ergometer. Gas exchange will be monitored continuously; the highest rate of oxygen uptake achieved (i.e. peak VO2 in mL/kg/min) during the last minute of the CPET will represent exercise capacity.
Baseline
Exercise capacity - maximal oxygen uptake (VO2peak)
Time Frame: Week 6
will be measured using a gold standard symptom-limited, cardiopulmonary exercise test (CPET) on an electronically braked cycle ergometer. Gas exchange will be monitored continuously; the highest rate of oxygen uptake achieved (i.e. peak VO2 in mL/kg/min) during the last minute of the CPET will represent exercise capacity.
Week 6
Exercise capacity - maximal oxygen uptake (VO2peak)
Time Frame: Following 12-weeks of intervention
will be measured using a gold standard symptom-limited, cardiopulmonary exercise test (CPET) on an electronically braked cycle ergometer. Gas exchange will be monitored continuously; the highest rate of oxygen uptake achieved (i.e. peak VO2 in mL/kg/min) during the last minute of the CPET will represent exercise capacity.
Following 12-weeks of intervention
Mental health - Anxiety levels
Time Frame: Baseline
measured using the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire.GAD-7 is a validated, self-reported anxiety questionnaire. The GAD-7 is a 7-item questionnaire developed to identify probable cases of generalized anxiety disorder. The GAD-7 score ranges from 0 - 21, where scores between 10-14 indicate moderate levels of anxiety and scores over 15 indicate severe anxiety.
Baseline
Mental health - Anxiety levels
Time Frame: Following 12-weeks of intervention
measured using the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire.GAD-7 is a validated, self-reported anxiety questionnaire. The GAD-7 is a 7-item questionnaire developed to identify probable cases of generalized anxiety disorder. The GAD-7 score ranges from 0 - 21, where scores between 10-14 indicate moderate levels of anxiety and scores over 15 indicate severe anxiety.
Following 12-weeks of intervention
Mental health - Depression levels
Time Frame: Baseline and following 12-weeks of intervention
measured using the Patient Health Questionnaire (PHQ-9) questionnaire. The PHQ-9 is a nine-symptom checklist questionnaire, where each question score ranges from 0 - 3. The total score ranges from 0-27 and it is divided into 5 levels: 0-4 (minimal); 5-9 (mild); 10-14 (moderate;) 15-19 (moderately severe) and 20-27 (severe depression).
Baseline and following 12-weeks of intervention
Mental health - Depression levels
Time Frame: Following 12-weeks of intervention
measured using the Patient Health Questionnaire (PHQ-9) questionnaire. The PHQ-9 is a nine-symptom checklist questionnaire, where each question score ranges from 0 - 3. The total score ranges from 0-27 and it is divided into 5 levels: 0-4 (minimal); 5-9 (mild); 10-14 (moderate;) 15-19 (moderately severe) and 20-27 (severe depression).
Following 12-weeks of intervention
Cardiometabolic health indicators - Blood pressure
Time Frame: Baseline
Resting systolic and diastolic blood pressure will be measured in a seated position after a 5-minute rest period on the right arm using an automated, blood pressure monitor.
Baseline
Cardiometabolic health indicators - Blood pressure
Time Frame: Following 12-weeks of intervention
Resting systolic and diastolic blood pressure will be measured in a seated position after a 5-minute rest period on the right arm using an automated, blood pressure monitor.
Following 12-weeks of intervention
Cardiometabolic health indicators - Heart rate
Time Frame: Baseline
measured in a seated position after a 5-minute rest period using an automated blood pressure monitor.
Baseline
Cardiometabolic health indicators - Heart rate
Time Frame: Following 12-weeks of intervention
measured in a seated position after a 5-minute rest period using an automated blood pressure monitor.
Following 12-weeks of intervention
Cardiometabolic health indicators - Body mass index
Time Frame: Baseline
Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2).
Baseline
Cardiometabolic health indicators - Body mass index
Time Frame: Following 12-weeks of intervention
Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2).
Following 12-weeks of intervention
Cardiometabolic health indicators - Fat mass
Time Frame: Baseline
Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.
Baseline
Cardiometabolic health indicators - Fat mass
Time Frame: Following 12-weeks of intervention
Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.
Following 12-weeks of intervention
Cardiometabolic health indicators - Waist circumference
Time Frame: Baseline
will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).
Baseline
Cardiometabolic health indicators - Waist circumference
Time Frame: Following 12-weeks of intervention
will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).
Following 12-weeks of intervention
Cardiometabolic health indicators - Menstrual status
Time Frame: Baseline
The menstrual status will be collected via a questionnaire.
Baseline
Cardiometabolic health indicators - Menstrual status
Time Frame: Following 12-weeks of intervention
The menstrual status will be collected via a questionnaire.
Following 12-weeks of intervention
Self-determined motivation for exercise
Time Frame: baseline
the 24-item Behavioural Regulation in Exercise questionnaire (BREQ-3) yields an overall Relative Autonomy Index (RAI) score, representing overall self-determined motivation.Each item is rated on a 5-point Likert scale (0-4), with higher scores representing greater self-determined motivation for exercise.
baseline
Self-determined motivation for exercise
Time Frame: following 12-weeks of intervention
the 24-item Behavioural Regulation in Exercise questionnaire (BREQ-3) yields an overall Relative Autonomy Index (RAI) score, representing overall self-determined motivation. Each item is rated on a 5-point Likert scale (0-4), with higher scores representing greater self-determined motivation for exercise.
following 12-weeks of intervention
Quality of life (self-reported)
Time Frame: Baseline
will be measured using the 36-Item Short Form Health Survey questionnaire (SF-36). The SF-36 is a widely used and thoroughly validated, standardized, generic health survey with 36 questions. It yields an 8-scale (physical functioning; role-physical; bodily pain; general health; vitality; social functioning; role-emotional; and, mental health) profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental (MCS) component summary scores. The PCS has been shown to be one of the most valid SF-36 scales for measuring physical health. The score ranges from 0 (low) to 100 (high). The lower the score the more disability. Higher scores indicate better health status.
Baseline
Quality of life (self-reported)
Time Frame: Following 12-weeks of intervention
will be measured using the 36-Item Short Form Health Survey questionnaire (SF-36). The SF-36 is a widely used and thoroughly validated, standardized, generic health survey with 36 questions. It yields an 8-scale (physical functioning; role-physical; bodily pain; general health; vitality; social functioning; role-emotional; and, mental health) profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental (MCS) component summary scores. The PCS has been shown to be one of the most valid SF-36 scales for measuring physical health. The score ranges from 0 (low) to 100 (high). The lower the score the more disability. Higher scores indicate better health status.
Following 12-weeks of intervention
Exercise self-efficacy
Time Frame: baseline
the 9-item Multidimensional Self-Efficacy for Exercise Scale (MSES-R) yields an overall self-efficacy for exercise score reflecting scheduling, task, and coping self-efficacy. Participants are asked: "How confident are you that you can exercise when…" and respond to each item on a 100% confidence scale (0-100). A higher score indicates higher self-efficacy for exercise.
baseline
Exercise self-efficacy
Time Frame: following 12-weeks of intervention
the 9-item Multidimensional Self-Efficacy for Exercise Scale (MSES-R) yields an overall self-efficacy for exercise score reflecting scheduling, task, and coping self-efficacy. Participants are asked: "How confident are you that you can exercise when…" and respond to each item on a 100% confidence scale (0-100). A higher score indicates higher self-efficacy for exercise.
following 12-weeks of intervention
Physical activity enjoyment
Time Frame: baseline
the 18-item Physical Activity Enjoyment Scale (PACES) measures the extent (on a 7-point Likert scale) to which participants enjoy doing physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" from 1 (I enjoy it) to 7 (I hate it). The score ranges from 18-126. Higher scores indicate higher enjoyment.
baseline
Physical activity enjoyment
Time Frame: following 12-weeks of intervention
the 18-item Physical Activity Enjoyment Scale (PACES) measures the extent (on a 7-point Likert scale) to which participants enjoy doing physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" from 1 (I enjoy it) to 7 (I hate it). The score ranges from 18-126. Higher scores indicate higher enjoyment.
following 12-weeks of intervention
Gender-Related Variables
Time Frame: baseline a
Participants will complete the Genesis-Praxy questionnaire (20-item). The gender score is used to categorize patients according to the masculine and feminine characteristics they present (i.e., according to their gender profile). The score represents the probability between 0% and 100% for each patient to be a "woman." Therefore, the gender scale is considered a continuum, ranging from masculine characteristics (gender scores toward zero) to feminine traits (gender scores toward one hundred). This scale does not assess worse or better outcomes.
baseline a
Gender-Related Variables
Time Frame: following 12-weeks of intervention
Participants will complete the Genesis-Praxy questionnaire (20-item). The gender score is used to categorize patients according to the masculine and feminine characteristics they present (i.e., according to their gender profile). The score represents the probability between 0% and 100% for each patient to be a "woman." Therefore, the gender scale is considered a continuum, ranging from masculine characteristics (gender scores toward zero) to feminine traits (gender scores toward one hundred). This scale does not assess worse or better outcomes.
following 12-weeks of intervention
Gender identity
Time Frame: baseline
Participants will complete the Traditional Masculinity and Femininity scale (TMF), designed to assess central facets of self-ascribed masculinity-femininity. A 7-point scale is used to gauge the extent to which the participant feels feminine or masculine (e.g., how feminine or masculine she or he ideally would like to be, and how feminine and masculine her or his appearance, interests, attitudes, and behavior would traditionally be seen). This scale does not assess worse or better outcomes.
baseline
Gender identity
Time Frame: following 12-weeks of intervention
Participants will complete the Traditional Masculinity and Femininity scale (TMF), designed to assess central facets of self-ascribed masculinity-femininity. A 7-point scale is used to gauge the extent to which the participant feels feminine or masculine (e.g., how feminine or masculine she or he ideally would like to be, and how feminine and masculine her or his appearance, interests, attitudes, and behavior would traditionally be seen). This scale does not assess worse or better outcomes.
following 12-weeks of intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Focus groups
Time Frame: Following 12-weeks of intervention
semi-structured focus group using Zoom Healthcare with purposively selected patients to explore factors influencing compliance and satisfaction with MICT or HIIT.
Following 12-weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Heart Institute Research Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Reed, PhD, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230095-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results from this study may be presented at scientific conferences and/or published in journals but participants will not be identifiable in any publications or presentations. Data can be made available upon request by contacting the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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