Your session is about to expire
← Back to Search
Behavioural Intervention
Exercise Training for Cardiovascular Disease (CIED-EX Trial)
N/A
Recruiting
Led By Jennifer Reed, PhD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
CIED-EX Trial Summary
This trial will investigate the effects of HIIT vs. MICT on physical, mental and quality of life of women with CIEDs, using a mixed-methods approach.
Who is the study for?
This trial is for women with cardiac devices (CIED) who've had them for at least 6 months, can read English or French, and are able to do a CPET exercise test. They should be on optimal medical therapy and not already doing regular exercise more than twice a week. Women who are pregnant or without internet cannot join.Check my eligibility
What is being tested?
The study compares two types of virtual exercise programs over 12 weeks: moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT). It aims to see which one better improves fitness, quality of life, and mental health in women with CIED.See study design
What are the potential side effects?
While the trial itself doesn't involve medication that could cause side effects, exercising might lead to muscle soreness, fatigue, or in rare cases exacerbate underlying heart conditions. Participants will be monitored closely for any adverse reactions.
CIED-EX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility - Adverse events
Feasibility - Compliance to the exercise prescription based on heart rate
Feasibility - Number of classes participants attended
+1 moreSecondary outcome measures
Cardiometabolic health indicators - Blood pressure
Cardiometabolic health indicators - Body mass index
Cardiometabolic health indicators - Fat mass
+12 moreOther outcome measures
Focus groups
CIED-EX Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard care + moderate-intensity continuous exercise training (MICT)Experimental Treatment1 Intervention
Supervised virtual MICT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.
Group II: Standard care + high-intensity interval training (HIIT)Experimental Treatment1 Intervention
Supervised virtual HIIT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,416 Total Patients Enrolled
Jennifer Reed, PhDPrincipal InvestigatorOttawa Heart Institute Research Corporation
4 Previous Clinical Trials
262 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to sign a consent form.I am a woman with a cardiac implant for over 6 months.I cannot or will not return for follow-ups at week 12.I am a woman with a well-functioning cardiac device and on optimal medical therapy.I have been diagnosed with unstable chest pain.I do not want to be randomly assigned to high-intensity or moderate-intensity exercise.I have been diagnosed with COPD, severe heart valve disease, or thickened heart muscle.
Research Study Groups:
This trial has the following groups:- Group 1: Standard care + moderate-intensity continuous exercise training (MICT)
- Group 2: Standard care + high-intensity interval training (HIIT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity for volunteers to join this trial?
"According to the information available on clinicaltrials.gov, this medical trial is no longer accepting applicants. It was originally posted on August 1st 2023 but has not been updated since July 5th of that same year. Despite its closure, there are still 455 other studies actively recruiting participants at present."
Answered by AI
What key aims does this research endeavor hope to achieve?
"This study will monitor its primary measurable outcome, the feasibility of attending classes, at Week 12. Several secondary objectives are also in place to evaluate patient quality-of-life via a 36 item survey; levels of anxiety through an established 7 question assessment; and cardiometabolic health indicators such as resting systolic/diastolic blood pressure."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger