Exercise Training in Women With Cardiac Devices

NCT05946304 | Completed

• 1 other identifier: 20230095-01H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac implantable electronic devices (CIED) are established treatments for a variety of cardiac arrhythmias. Women with CIED have lower fitness and lower quality of life compared to men with CIED. Moderate-intensity continuous training (MICT) is the most prescribed exercise for women. However, high-intensity interval training (HIIT) has been shown to improve fitness, anxiety levels, quality of life, and other health indicators over MICT in men with CIED. There is a need to quantitatively evaluate the feasibility and effects of a virtual HIIT vs. virtual MICT program on the physical, quality of life, and mental health of women with CIED. Furthermore, a qualitative approach is also necessary to understand patients' experiences, barriers, and facilitators of a virtual exercise intervention. This mixed-methods pilot randomized controlled trial will assess the feasibility of a 12-week virtual HIIT and MICT program in women with CIED.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

• Feasibility - Number of classes participants attended

  Exercise attendance will be assessed by the number of classes participants attended. High attendance to the CR program will be defined as being present at ≥ 70% of the classes.

  Week 12

• Feasibility - Compliance to the exercise prescription based on heart rate

  Exercise compliance will be assessed as the ability to complete the prescribed intensity (based on the heart rate peak \[HR\] of the cardiopulmonary exercise test) for high-intensity interval training or moderate-intensity continuous training. The HRs across all classes for each patient will be averaged and compared to their target HR prescription. For instance, where patients exercised below, within, or above the prescribed HR ranges, these will be coded as "does not comply", "complies" and "exceeds".

  Week 12

• Feasibility - Adverse events

  Safety will be assessed by enumerating reported adverse events during the study period.

  Week 12

• Feasibility - Number of dropouts

  The number of patients who withdraw from the program will be reported as descriptive data and compared between groups (e.g., high-intensity interval program vs moderate-intensity continuous training).

  Week 12

Secondary Outcomes (31)

• Exercise capacity - maximal oxygen uptake (VO2peak)

  Baseline

• Exercise capacity - maximal oxygen uptake (VO2peak)

  Week 6

• Exercise capacity - maximal oxygen uptake (VO2peak)

  Following 12-weeks of intervention

• Quality of life (self-reported)

  Baseline

• Quality of life (self-reported)

  Following 12-weeks of intervention

Other Outcomes (1)

• Focus groups

  Following 12-weeks of intervention

Study Arms (2)

Standard care + moderate-intensity continuous exercise training (MICT)

EXPERIMENTAL

Supervised virtual MICT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.

Behavioral: moderate-intensity continuous exercise training (MICT) group

Standard care + high-intensity interval training (HIIT)

EXPERIMENTAL

Supervised virtual HIIT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.

Behavioral: high-intensity interval training (HIIT) group

Interventions

moderate-intensity continuous exercise training (MICT) group BEHAVIORAL

Exercise session: Warm-up: 60-70% peak heart rate (HR) - 10min; Training: 70-85% peak HR - 35min; Cool-down: 60-70% peak HR - 15min.

Standard care + moderate-intensity continuous exercise training (MICT)

high-intensity interval training (HIIT) group BEHAVIORAL

Warm-up: 60-70% peak heart rate (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.

Standard care + high-intensity interval training (HIIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women (i.e., female sex assigned at birth) with CIED (≥6 months since implant)
• Women with CIED in optimal medical therapy and functioning;
• Patient is able to perform a symptom-limited CPET;
• Patient is able to read and understand English or French.

You may not qualify if:

• Patient is currently participating in routine exercise training (\>2x/week);
• Patient has: documented unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
• Patient has an unmanaged psychiatric illness (e.g., active psychosis, suicidal ideation) or cognitive impairment;
• Patient does not have an internet connection or a device with a camera and speakers;
• Patient with any device troubleshooting at resting or during exercise;
• Patient is unable to provide written informed consent;
• Patient is unwilling or unable to return for follow-up visits at week 12;
• Patient is unwilling to be randomized to HIIT or MICT; or
• Pregnancy or patients who become pregnant during the 12-week intervention phase (the effects of interval training on an unborn fetus are unknown).

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Population Groups; High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer Reed, PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 14, 2023
• Study Start: November 28, 2023
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)