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Completed

NCT Number: NCT04781504

Exercise Training in Women With Heart Disease

Coronary heart disease (CHD) is a leading cause of premature death in Canadian women. Women who suffer an acute coronary event are more likely than men to be physically inactive, have lower exercise capacity, and die in the next year. The standard cardiac rehabilitation (CR) programs do not meet women's needs. There is a need to address these issues to increase participation in CR. The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) on exercise capacity and quality of life in women with CHD. Positive results of this study will fill the gap in knowledge in exercise training, levels of motivation, self-efficacy and enjoyment following HIIT vs. MICE in women with CHD.

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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

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 with CHD (e.g. CABG or PCI at least 4 weeks but less than 12 weeks post event or procedure; acute myocardial infarction; or, stable angina with corroborating evidence of CHD);
  • Patient is able to perform a symptom-limited CPET (this is 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) (this may reduce the impact of the program on outcomes);
  • Patient has: a ventricular ejection fraction <45%; 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 MICE or HIIT);
  • Patient has unmanaged psychiatric illness (e.g. active psychosis, suicidal ideation) or cognitive impairment (this may confound improvements in physical and health outcomes);
  • Patient does not have internet connection;
  • 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 MICE

Treatment and study plan

Exercise

Behavioral

intervention groups will complete supervised virtual exercise sessions for 12 weeks using the platform preferred by the patient (Zoom care, Zoom business, Google duo, google meet, FaceTime, join.me, WhatsApp Call, etc). The appointment will be scheduled and conducted 2 days per week. The first class will be conducted on-site to teach the patient how to take vitals and to do an in-person exercise session

Primary outcomes

  1. Change in 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 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.

Secondary outcomes

  1. physical and mental health

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

    physical 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

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

    measured using the General Anxiety and Depression-7 (GAD-7). Score ranges from 0-21 where higher scores means a more severe level of anxiety.

  4. Depression

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

    measured using the Patient Health Questionnaire (PHQ-9). Scores range from 1-27 where higher scores means higher depression severity.

  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 6 times (the first will be discarded and an average of the last 5 measurements will be used for statistical analyses) 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 - TMF

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

    using the Traditional Masculinity and Femininity scale (TMF). A score close to 4 refers to be moderately feminine and masculine.

  14. Gender - Genesis-Praxy

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

    using the Genesis-Praxy questionnaire.

  15. COVID-19 Signs and Symptoms, Complications and Treatments

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

    using a self-reported questionnaire. No score reported with this 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

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: EXCEED

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2021
Registry last updated
May 7, 2024

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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