Exercise Training in Women With Cardiac Devices

Cardiovascular Diseases Clinical Trial

— CIED-EX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05946304
• Other study ID #: 20230095-01H
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: Jennifer Reed, PhD
• Phone: 613-696-7392
• Email: jreed[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Focus groups	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
Primary	Feasibility - Number of classes participants attended	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
Primary	Feasibility - Compliance to the exercise prescription based on heart rate	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
Primary	Feasibility - Adverse events	Safety will be assessed by enumerating reported adverse events during the study period.	Week 12
Primary	Feasibility - Number of dropouts	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	Exercise capacity - maximal oxygen uptake (VO2peak)	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
Secondary	Exercise capacity - maximal oxygen uptake (VO2peak)	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
Secondary	Exercise capacity - maximal oxygen uptake (VO2peak)	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
Secondary	Quality of life (self-reported)	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
Secondary	Quality of life (self-reported)	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
Secondary	Mental health - Anxiety levels	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
Secondary	Mental health - Anxiety levels	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
Secondary	Mental health - Depression levels	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
Secondary	Mental health - Depression levels	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
Secondary	Cardiometabolic health indicators - Blood pressure	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
Secondary	Cardiometabolic health indicators - Blood pressure	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
Secondary	Cardiometabolic health indicators - Heart rate	measured in a seated position after a 5-minute rest period using an automated blood pressure monitor.	Baseline
Secondary	Cardiometabolic health indicators - Heart rate	measured in a seated position after a 5-minute rest period using an automated blood pressure monitor.	Following 12-weeks of intervention
Secondary	Cardiometabolic health indicators - Body mass index	Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2).	Baseline
Secondary	Cardiometabolic health indicators - Body mass index	Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2).	Following 12-weeks of intervention
Secondary	Cardiometabolic health indicators - Fat mass	Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.	Baseline
Secondary	Cardiometabolic health indicators - Fat mass	Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.	Following 12-weeks of intervention
Secondary	Cardiometabolic health indicators - Waist circumference	will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).	Baseline
Secondary	Cardiometabolic health indicators - Waist circumference	will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).	Following 12-weeks of intervention
Secondary	Cardiometabolic health indicators - Menstrual status	The menstrual status will be collected via a questionnaire.	Baseline
Secondary	Cardiometabolic health indicators - Menstrual status	The menstrual status will be collected via a questionnaire.	Following 12-weeks of intervention
Secondary	Self-determined motivation for exercise	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
Secondary	Self-determined motivation for exercise	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
Secondary	Exercise self-efficacy	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
Secondary	Exercise self-efficacy	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
Secondary	Physical activity enjoyment	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
Secondary	Physical activity enjoyment	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
Secondary	Gender-Related Variables	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
Secondary	Gender-Related Variables	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
Secondary	Gender identity	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
Secondary	Gender identity	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