Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06494163

Exercise Training in Women With Heart Disease 2

This study will compare the effects of two different types of training on exercise capacity in women with coronary heart disease (CHD). Participants will be randomized into either the virtual high-intensity interval training (HIIT) or the virtual moderate-to-vigorous intensity continuous training (MICT). After randomization, patients will exercise twice a week, for 12 weeks. The sessions will be conducted virtually. Patients will undergo a maximal exercise test, cardiometabolic indicators (height (cm), body mass (kg), body composition (%), waist circumference (cm) and, resting blood pressure) and complete questionnaires about quality of life, mental health, self-determined motivation, self-efficacy and enjoyment.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cardiovascular Diseases Coronary Disease Coronary Heart Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Heart disease is a leading cause of death for women. Women who suffer a heart attack are more likely than men to be inactive, have lower fitness, and die in the next year; patients also report poor mental health and quality of life (QoL), and have a greater risk of cardiovascular disease risk factors. This clinical research project is concerned about women with heart disease and how to improve their fitness, mental health, and QoL using a different kind of exercise. Currently, moderate-to-vigorous intensity continuous training, MICT, is the most frequently prescribed for women with heart disease. Unfortunately, this exercise tends to be a burden and is time-consuming. The study aims to test if high-intensity interval training (HIIT, alternating periods of hard exercise and rest) is better than MICT at improving fitness, mental health, QoL, and exercise dedication in women with heart disease. The investigators will recruit 104 women with heart disease. The investigators will first assess the health measures outlined above and then randomly assign people to MICT or HIIT. Both groups will attend virtual exercise sessions 2 days/week for 12 weeks. The MICT group will perform Zumba/movement-based exercise for 35 minutes at an intensity level of 70-85% of their maximal effort. The HIIT group will perform Zumba/movement-based exercise for 25-minutes: this will consist of 4 periods of exercising for 4-minutes at an intensity level of 85-95% of their maximal effort, separated by 3 minutes of rest between each period. The investigators will assess the health measures again after 12 and 26 weeks. The scores for people in the two groups will then be compared. HIIT has never been evaluated as an alternative for MICT in a large women-only group with heart disease. If this clinical trial shows that HIIT helps these women improve their physical and psychosocial health over usual practice, then health care professionals caring for women with heart disease will have an alternative, effective treatment option to provide women in need.

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 CHD (e.g., coronary artery bypass grafting surgery [CABG], percutaneous coronary intervention [PCI], acute myocardial infarction [MI], MI with no obstructive coronary artery disease [MINOCA], or ischemia with no obstructive coronary artery disease [INOCA] at least 4 weeks post procedure or event; based on clinical evidence this is a safe period of time to exercise);
  • Patient is able to perform a symptom limited CPET (this is the primary outcome and needed to determine peak HR for the exercise training prescription); and
  • Patient is able to read and understand English or French.

Exclusion criteria

  • Patient is currently participating in routine exercise training (>2x/week, routine exercise training is defined as a planned, structured, and repetitive exercise that is performed in order to maintain or improve physical fitness.) (this may reduce the impact of HIIT or MICT on outcomes);
  • Patient has: NYHA class III-IV heart failure symptoms; unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy (this may interfere with the ability to engage in MICT or HIIT);
  • Patient has uncontrolled arrhythmia (this may impact the HR-based exercise training prescription and monitoring);
  • Patient is unable to provide written informed consent; or
  • Patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks.
  • Patient is unwilling to be randomized to HIIT or MICT.

Treatment and study plan

Exercise

Behavioral

The MICT and HIIT intervention groups will complete supervised virtual exercise sessions for 12 weeks using Zoom care or Microsoft Teams as a backup resource. The appointments will be scheduled and conducted 2 days per week. Initially, exercise intensity will be determined from participants' peak HR achieved during a baseline CPET.

Primary outcomes

  1. Exercise capacity

    Time frame: from baseline to week-6 and from baseline to week-12

    will be measured using a gold standard symptom-limited, cardiopulmonary exercise test (CPET) on a treadmill (or on an alternate equipment, such as a cycle ergometer or recumbent bike). Gas exchange will be monitored continuously (- Parvo Medics TrueOne® 2400); the highest 20 second average rate of oxygen uptake achieved (i.e. peak VO2 in mL/kg/min) during the last minute of the CPET will represent exercise capacity.

Secondary outcomes

  1. physical and mental health

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    hysical and mental health will be measured using the Mental Health Composite Scale (MCS) and Physical Composite Scale (PCS) of the Short Form-36 questionnaire. It consists of 36 items that contribute to eight subscales summarized into a physical component summary scale (PCS) and a mental component summary scale (MCS). A higher score on a 0-100 scale indicates a better quality of life.

  2. Disease-specific Quality of Life, global health, physical and emotional health

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    measured using the HeartQoL, a validated 14-item questionnaire that assesses patients' feelings on how heart disease affects daily functioning, providing a global-health related QoL score and physical and emotional subscales. Higher score means better quality of life. Score range from 0-3, where higher scores represents better heart quality of life.

  3. Anxiety symptoms

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    assessed with the Generalized Anxiety Disorder-7 (GAD-7).Participants rate statements regarding symptoms of anxiety on a 4-point scale (0=not at all; 4=nearly every day). The items are summed to obtain a score ranging from 0-21.

  4. Depressive symptoms

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    Depressive symptoms: assessed with the Patient Health Questionnaire (PHQ-9), a 9-item scale based on diagnostic criteria for depressive disorders. Participants rate statements on a 4-point scale (0=not at all; 4=nearly every day), yielding a single score indicating severity of depression symptoms.

  5. body composition - BMI

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    body mass (kg) and height (cm) will be measured to calculate body mass index (kg/m^2)

  6. body composition - Waist circumference

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by waist circumference (cm).

  7. body composition - BIA

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by bioelectrical impedance (%)

  8. Vital Signs - Resting Blood Pressure

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    changes in vital signs will be measured using resting blood pressure (mmHg) in a seated position after a 5-minute rest period on the right arm using an automated monitor (BPTru) that measures 3 times at 2-minute intervals.

  9. Vital Signs - Resting Heart Rate

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    changes in vital signs will be measured using resting heart rate (bpm)

  10. Self-determined motivation for exercise

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    the 24-item Behavioural Regulation in Exercise questionnaire (BREQ-3) yields an overall Relative Autonomy Index (RAI) score, representing overall self-determined motivation. The scale ranges from -3 "amotivation to +3 "intrinsic regulation".

  11. Overall self-efficacy for exercise

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    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. The MSES consists of nine items on a 100% confidence scale ranging from 0 = "no confidence" to 100 = "completely confident."

  12. physical activity enjoyment

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    the 18-item Physical Activity Enjoyment Scale (PACES) measures the extent (on a 7-point Likert scale) to which participants enjoy doing physical activity. Overall enjoyment for physical activity score is determined by summing the items, with a range of 18-126 being possible. Higher scores indicate higher enjoyment.

  13. Gender

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    assessed using the Genesis-Praxy questionnaire.

Other outcomes

  1. Physical activity levels

    Time frame: from baseline to 12 weeks and baseline to 26 weeks

    will be measured objectively. The ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, Florida) will be worn over the right hip for 7 days

  2. Program compliance

    Time frame: from baseline to 12 weeks

    Staff will record the number of MICT or HIIT sessions attended over the 12-week period (attended/prescribed x 100 = % compliance). Staff will record the number of MICT or HIIT sessions attended over the 14 weeks of unsupervised virtual exercise session.

    Reasons for missing exercise sessions and program drop-out will be collected to inform the development of strategies to engage women in CR.

  3. Participant Experience

    Time frame: at 12 weeks

    As per the ORBIT model166 for developing effective behavioural treatments for chronic diseases, semi-structured focus groups (N=4)167 with patients (N=20, purposively selected according to age, gender, and medical conditions)168 will be conducted at 12 weeks to explore factors influencing adherence and satisfaction with MICT or HIIT. Each focus group will be 60-90 minutes in duration and will be held at times convenient for the participants

  4. Feeling Scale

    Time frame: during intervention

    To assess affective response during exercise, the Feeling Scale will be completed during and immediately post exercise. The patient will report the value in a one-on-one chat function. The FS is an 11-point, single-item, bipolar rating scale commonly used for the assessment of affective valence (i.e., please-displeasure) during exercise. The scale ranges from -5 ("Very Bad") to +5 ("Very Good").

  5. Participant Feedback

    Time frame: from baseline to 12 weeks

    To assess the participant's experience using a virtual intervention method.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Reed, PhD

CONTACT

[email protected]

613-696-7392

Matheus Mistura, MSc

CONTACT

[email protected]

6136967000 ext. 15944

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

Exercise Training in Women With Heart Disease: A Randomized Controlled Trial

Acronym: EXCEED2

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 10, 2024
Registry last updated
Mar 11, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.