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Exercise Training in Women With Heart Disease (EXCEED)

Primary Purpose

Cardiovascular Diseases, Coronary Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Ottawa Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

standard care + moderate-intensity continuous exercise training

standard care + high-intensity interval training

Arm Description

2 days/week Warm-up: 60-70% peak HR - 10min Training: 70-85% peak HR - 35min Cool-down: 60-70% peak HR - 15min

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

Outcomes

Primary Outcome Measures

Change in Exercise capacity
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

physical and mental health
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.
Disease-specific Quality of Life, global health, physical and emotional health
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.
Anxiety
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.
Depression
measured using the Patient Health Questionnaire (PHQ-9). Scores range from 1-27 where higher scores means higher depression severity.
body composition - BMI
body mass (kg) and height (cm) will be measured to calculate body mass index (kg/m^2)
body composition - Waist circumference
Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by waist circumference (cm).
body composition - BIA
Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by bioelectrical impedance (%)
Vital Signs - Resting Blood Pressure
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.
Vital Signs - Resting Heart Rate
changes in vital signs will be measured using resting heart rate (bpm)
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. The scale ranges from -3 "amotivation to +3 "intrinsic regulation".
Overall self-efficacy for exercise
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."
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. 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.
Gender - TMF
using the Traditional Masculinity and Femininity scale (TMF). A score close to 4 refers to be moderately feminine and masculine.
Gender - Genesis-Praxy
using the Genesis-Praxy questionnaire.
COVID-19 Signs and Symptoms, Complications and Treatments
using a self-reported questionnaire. No score reported with this questionnaire

Full Information

First Posted
October 30, 2020
Last Updated
September 1, 2023
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04781504
Brief Title
Exercise Training in Women With Heart Disease
Acronym
EXCEED
Official Title
Exercise Training in Women With Heart Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard care + moderate-intensity continuous exercise training
Arm Type
Experimental
Arm Description
2 days/week Warm-up: 60-70% peak HR - 10min Training: 70-85% peak HR - 35min Cool-down: 60-70% peak HR - 15min
Arm Title
standard care + high-intensity interval training
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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 Measure Information:
Title
Change in Exercise capacity
Description
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.
Time Frame
from baseline to week-6 and from baseline to week-12
Secondary Outcome Measure Information:
Title
physical and mental health
Description
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.
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
Disease-specific Quality of Life, global health, physical and emotional health
Description
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.
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
Anxiety
Description
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.
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
Depression
Description
measured using the Patient Health Questionnaire (PHQ-9). Scores range from 1-27 where higher scores means higher depression severity.
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
body composition - BMI
Description
body mass (kg) and height (cm) will be measured to calculate body mass index (kg/m^2)
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
body composition - Waist circumference
Description
Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by waist circumference (cm).
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
body composition - BIA
Description
Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by bioelectrical impedance (%)
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
Vital Signs - Resting Blood Pressure
Description
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.
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
Vital Signs - Resting Heart Rate
Description
changes in vital signs will be measured using resting heart rate (bpm)
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
Self-determined motivation for exercise
Description
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".
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
Overall self-efficacy for exercise
Description
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."
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
Physical activity enjoyment
Description
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.
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
Gender - TMF
Description
using the Traditional Masculinity and Femininity scale (TMF). A score close to 4 refers to be moderately feminine and masculine.
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
Gender - Genesis-Praxy
Description
using the Genesis-Praxy questionnaire.
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Title
COVID-19 Signs and Symptoms, Complications and Treatments
Description
using a self-reported questionnaire. No score reported with this questionnaire
Time Frame
from baseline to 12 weeks and baseline to 26 weeks
Other Pre-specified Outcome Measures:
Title
Physical activity levels
Description
will be measured objectively. The ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, Florida) will be worn over the right hip for 7 days
Time Frame
from baseline to 12 weeks and baseline to 26 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Reed, PhD
Phone
613-696-7392
Email
jreed@ottawaheart.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Matheus Mistura, MSc
Phone
6136967000
Ext
15944
Email
mmistura@ottawaheart.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Reed, PhD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer L Reed, PhD
Phone
6136967392
Ext
67392
Email
jreed@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Matheus Mistura, MSc, BSc
Phone
6136967000
Ext
15944
Email
mmistura@ottawaheart.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
it is not yet known if there will be a plan to make IPD available.

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Exercise Training in Women With Heart Disease

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