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Completed

NCT Number: NCT05946304

Exercise Training in Women With Cardiac Devices

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women (i.e., female sex assigned at birth) with CIED (≥6 months since implant)
  • Women with CIED in optimal medical therapy and functioning;
  • Patient is able to perform a symptom-limited CPET;
  • Patient is able to read and understand English or French.

Exclusion criteria

  • Patient is currently participating in routine exercise training (>2x/week);
  • Patient has: documented unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
  • Patient has an unmanaged psychiatric illness (e.g., active psychosis, suicidal ideation) or cognitive impairment;
  • Patient does not have an internet connection or a device with a camera and speakers;
  • Patient with any device troubleshooting at resting or during exercise;
  • Patient is unable to provide written informed consent;
  • Patient is unwilling or unable to return for follow-up visits at week 12;
  • Patient is unwilling to be randomized to HIIT or MICT; or
  • Pregnancy or patients who become pregnant during the 12-week intervention phase (the effects of interval training on an unborn fetus are unknown).

Treatment and study plan

moderate-intensity continuous exercise training (MICT) group

Behavioral

Exercise session: Warm-up: 60-70% peak heart rate (HR) - 10min; Training: 70-85% peak HR - 35min; Cool-down: 60-70% peak HR - 15min.

high-intensity interval training (HIIT) group

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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".

  3. Feasibility - Adverse events

    Time frame: Week 12

    Safety will be assessed by enumerating reported adverse events during the study period.

  4. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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).

  15. 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).

  16. Cardiometabolic health indicators - Fat mass

    Time frame: Baseline

    Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.

  17. 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.

  18. Cardiometabolic health indicators - Waist circumference

    Time frame: Baseline

    will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).

  19. 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).

  20. Cardiometabolic health indicators - Menstrual status

    Time frame: Baseline

    The menstrual status will be collected via a questionnaire.

  21. Cardiometabolic health indicators - Menstrual status

    Time frame: Following 12-weeks of intervention

    The menstrual status will be collected via a questionnaire.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Acronym: CIED-EX

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2023
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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