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Exercise Training in Women With Heart Disease (EXCEED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04781504
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Jennifer Reed, Ottawa Heart Institute Research Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Heart Disease Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Exercise Training in Women With Heart Disease: A Randomized Controlled Trial
Actual Study Start Date : April 5, 2021
Estimated Primary Completion Date : January 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: standard care + moderate-intensity continuous exercise training
2 days/week Warm-up: 60-70% peak HR - 10min Training: 70-85% peak HR - 35min Cool-down: 60-70% peak HR - 15min
Behavioral: Exercise
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

Experimental: standard care + high-intensity interval training
2 days/week Warm-up: 60-70% peak 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
Behavioral: Exercise
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781504


Contacts
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Contact: Jennifer Reed, PhD 613-696-7392 jreed@ottawaheart.ca
Contact: Matheus Mistura, MSc 6136967000 ext 15944 mmistura@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Jennifer L Reed, PhD    6136967392 ext 67392    jreed@ottawaheart.ca   
Contact: Matheus Mistura, MSc, BSc    6136967000 ext 15944    mmistura@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Jennifer Reed, PhD Ottawa Heart Institute Research Corporation
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Responsible Party: Jennifer Reed, Principal Investigator, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT04781504    
Other Study ID Numbers: 20200732-01H
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: it is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases