Cardiovascular DiseasesCIED-EXNCT05946304
Exercise Training in Women With Cardiac Devices
A study testing moderate-intensity continuous exercise training (MICT) group and high-intensity interval training (HIIT) group in people with Cardiovascular Diseases, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- moderate-intensity continuous exercise training (MICT) group and high-intensity interval training (HIIT) group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2023to 18 Aug 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- moderate-intensity continuous exercise training (MICT) group, high-intensity interval training (HIIT) group
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate-intensity continuous exercise training (MICT) groupBehavioural
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) groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care + moderate-intensity continuous exercise training (MICT) | Experimental | Supervised virtual MICT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care. Receives: Behavioral: moderate-intensity continuous exercise training (MICT) group |
| Standard care + high-intensity interval training (HIIT) | Experimental | Supervised virtual HIIT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care. Receives: Behavioral: high-intensity interval training (HIIT) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
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".
Measured: Week 12
Feasibility - Adverse events
Safety will be assessed by enumerating reported adverse events during the study period.
Measured: Week 12
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).
Measured: Week 12
Secondary outcomes (31)
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.
Measured: Baseline
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.
Measured: Week 6
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.
Measured: Following 12-weeks of intervention
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.
Measured: Baseline
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.
Measured: Following 12-weeks of intervention
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.
Measured: Baseline
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.
Measured: Following 12-weeks of intervention
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).
Measured: Baseline and following 12-weeks of intervention
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).
Measured: Following 12-weeks of intervention
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.
Measured: Baseline
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.
Measured: Following 12-weeks of intervention
Cardiometabolic health indicators - Heart rate
measured in a seated position after a 5-minute rest period using an automated blood pressure monitor.
Measured: Baseline
Cardiometabolic health indicators - Heart rate
measured in a seated position after a 5-minute rest period using an automated blood pressure monitor.
Measured: Following 12-weeks of intervention
Cardiometabolic health indicators - Body mass index
Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2).
Measured: Baseline
Cardiometabolic health indicators - Body mass index
Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2).
Measured: Following 12-weeks of intervention
Cardiometabolic health indicators - Fat mass
Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.
Measured: Baseline
Cardiometabolic health indicators - Fat mass
Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.
Measured: Following 12-weeks of intervention
Cardiometabolic health indicators - Waist circumference
will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).
Measured: Baseline
Cardiometabolic health indicators - Waist circumference
will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).
Measured: Following 12-weeks of intervention
Cardiometabolic health indicators - Menstrual status
The menstrual status will be collected via a questionnaire.
Measured: Baseline
Cardiometabolic health indicators - Menstrual status
The menstrual status will be collected via a questionnaire.
Measured: Following 12-weeks of intervention
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.
Measured: baseline
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.
Measured: following 12-weeks of intervention
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.
Measured: baseline
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.
Measured: following 12-weeks of intervention
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.
Measured: baseline
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.
Measured: following 12-weeks of intervention
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.
Measured: baseline a
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.
Measured: following 12-weeks of intervention
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.
Measured: baseline
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.
Measured: following 12-weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start28 Nov 2023
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Reed, PhD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946304
- Sponsor's protocol ID
- 20230095-01H
- Acronym
- CIED-EX
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Training on Physical and Mental Health in Women With Cardiac Implantable Electronic Devices (CIED-EX): a Pilot Study
- ClinicalTrials.gov ID
- NCT05946304
- Acronym / sponsor ID
- CIED-EX / 20230095-01H
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 14 Jul 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care + moderate-intensity continuous exercise training (MICT) | Experimental | Behavioral: moderate-intensity continuous exercise training (MICT) groupSupervised virtual MICT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care. |
| Standard care + high-intensity interval training (HIIT) | Experimental | Behavioral: high-intensity interval training (HIIT) groupSupervised virtual HIIT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| moderate-intensity continuous exercise training (MICT) groupExercise session: Warm-up: 60-70% peak heart rate (HR) - 10min; Training: 70-85% peak HR - 35min; Cool-down: 60-70% peak HR - 15min. | Behavioural | Standard care + moderate-intensity continuous exercise training (MICT) |
| high-intensity interval training (HIIT) groupWarm-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. | Behavioural | Standard care + high-intensity interval training (HIIT) |
Primary outcome
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.
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".
Feasibility - Adverse events
Time frame: Week 12
Safety will be assessed by enumerating reported adverse events during the study period.
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).
31 secondary outcomes
Exercise capacity - maximal oxygen uptake (VO2peak)
Time frame: Baseline
Exercise capacity - maximal oxygen uptake (VO2peak)
Time frame: Week 6
Exercise capacity - maximal oxygen uptake (VO2peak)
Time frame: Following 12-weeks of intervention
Quality of life (self-reported)
Time frame: Baseline
Quality of life (self-reported)
Time frame: Following 12-weeks of intervention
Mental health - Anxiety levels
Time frame: Baseline
Mental health - Anxiety levels
Time frame: Following 12-weeks of intervention
Mental health - Depression levels
Time frame: Baseline and following 12-weeks of intervention
Mental health - Depression levels
Time frame: Following 12-weeks of intervention
Cardiometabolic health indicators - Blood pressure
Time frame: Baseline
Cardiometabolic health indicators - Blood pressure
Time frame: Following 12-weeks of intervention
Cardiometabolic health indicators - Heart rate
Time frame: Baseline
Cardiometabolic health indicators - Heart rate
Time frame: Following 12-weeks of intervention
Cardiometabolic health indicators - Body mass index
Time frame: Baseline
Cardiometabolic health indicators - Body mass index
Time frame: Following 12-weeks of intervention
Cardiometabolic health indicators - Fat mass
Time frame: Baseline
Cardiometabolic health indicators - Fat mass
Time frame: Following 12-weeks of intervention
Cardiometabolic health indicators - Waist circumference
Time frame: Baseline
Cardiometabolic health indicators - Waist circumference
Time frame: Following 12-weeks of intervention
Cardiometabolic health indicators - Menstrual status
Time frame: Baseline
Cardiometabolic health indicators - Menstrual status
Time frame: Following 12-weeks of intervention
Self-determined motivation for exercise
Time frame: baseline
Self-determined motivation for exercise
Time frame: following 12-weeks of intervention
Exercise self-efficacy
Time frame: baseline
Exercise self-efficacy
Time frame: following 12-weeks of intervention
Physical activity enjoyment
Time frame: baseline
Physical activity enjoyment
Time frame: following 12-weeks of intervention
Gender-Related Variables
Time frame: baseline a
Gender-Related Variables
Time frame: following 12-weeks of intervention
Gender identity
Time frame: baseline
Gender identity
Time frame: following 12-weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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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.
Jennifer Reed, PhD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate-intensity continuous exercise training (MICT) group and high-intensity interval training (HIIT) group in people with Cardiovascular Diseases, run by Ottawa Heart Institute Research Corporation at 1 site 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility - Number of classes participants attended (time frame: Week 12). The study lists 4 primary outcomes in all. 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 13 Mar 2026.