Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494163
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Exercise Training in Women With Heart Disease 2
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
Exercise Training in Women With Heart Disease A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXCEED2
Brief 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
Detailed Description:
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 daysweek for 12 weeks The MICT group will perform Zumbamovement-based exercise for 35 minutes at an intensity level of 70-85 of their maximal effort The HIIT group will perform Zumbamovement-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None