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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

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

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 more
Secondary outcome measures
Cardiometabolic health indicators - Blood pressure
Cardiometabolic health indicators - Body mass index
Cardiometabolic health indicators - Fat mass
+12 more
Other outcome measures
Focus groups

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
189 Previous Clinical Trials
92,301 Total Patients Enrolled
Jennifer Reed, PhDPrincipal InvestigatorOttawa Heart Institute Research Corporation
4 Previous Clinical Trials
115 Total Patients Enrolled

Media Library

High-intensity interval training (HIIT) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05946304 — N/A
Cardiovascular Disease Research Study Groups: Standard care + moderate-intensity continuous exercise training (MICT), Standard care + high-intensity interval training (HIIT)
Cardiovascular Disease Clinical Trial 2023: High-intensity interval training (HIIT) Highlights & Side Effects. Trial Name: NCT05946304 — N/A
High-intensity interval training (HIIT) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05946304 — N/A
~12 spots leftby Aug 2025
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