Exercise Training in Women With Heart Disease 2
NCT Number: NCT06494163
Acronym: EXCEED2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases|Coronary Heart Disease
Interventions: BEHAVIORAL: Exercise
Sponsor: Ottawa Heart Institute Research Corporation
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 172
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2029-03-30
Locations: University of Ottawa Heart Institute, Ottawa, Ontario, K1Y 4W7, Canada

Summary:
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.

Primary Outcome Measures: Exercise capacity, 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., from baseline to week-6 and from baseline to week-12
Secondary Outcome Measures: physical and mental health, 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., from baseline to 12 weeks and baseline to 26 weeks|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., from baseline to 12 weeks and baseline to 26 weeks|Anxiety symptoms, 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., from baseline to 12 weeks and baseline to 26 weeks|Depressive symptoms, 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., from baseline to 12 weeks and baseline to 26 weeks|body composition - BMI, body mass (kg) and height (cm) will be measured to calculate body mass index (kg/m\^2), from baseline to 12 weeks and baseline to 26 weeks|body composition - Waist circumference, Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by waist circumference (cm)., from baseline to 12 weeks and baseline to 26 weeks|body composition - BIA, Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by bioelectrical impedance (%), from baseline to 12 weeks and baseline to 26 weeks|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 3 times at 2-minute intervals., from baseline to 12 weeks and baseline to 26 weeks|Vital Signs - Resting Heart Rate, changes in vital signs will be measured using resting heart rate (bpm), from baseline to 12 weeks and baseline to 26 weeks|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"., from baseline to 12 weeks and baseline to 26 weeks|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.", from baseline to 12 weeks and baseline to 26 weeks|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., from baseline to 12 weeks and baseline to 26 weeks|Gender, assessed using the Genesis-Praxy questionnaire., from baseline to 12 weeks and baseline to 26 weeks
Other Outcome Measures: Physical activity levels, will be measured objectively. The ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, Florida) will be worn over the right hip for 7 days, from baseline to 12 weeks and baseline to 26 weeks|Program compliance, 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., from baseline to 12 weeks|Participant Experience, 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, at 12 weeks|Feeling Scale, 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")., during intervention|Participant Feedback, To assess the participant's experience using a virtual intervention method., from baseline to 12 weeks