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Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection (EXERCISE-SCAD)

U

University of Leicester

Status

Not yet enrolling

Conditions

Spontaneous Coronary Artery Dissection

Treatments

Behavioral: Exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT06955663
1018
SCOT23-100002 (Other Grant/Funding Number)

Details and patient eligibility

About

The study aims to examine the feasibility of a remote exercise program in women recovering from spontaneous coronary artery dissection (SCAD) events (heart attacks). Heart attacks caused by SCAD are different to the traditional heart attacks. In SCAD a tear happens within the blood vessels causing partial or full blockage. The population affected by SCAD is hugely different to the population affected by other 'traditional' heart attacks; as SCAD mainly happens in otherwise healthy women. From historical cases, SCAD has been associated with strenuous exercise, however, medical research did not find a link. The recovery after SCAD is also very different from other 'traditional' heart attacks. Cardiac rehab programmes are designed for an older population therefore they may not be suitable for a younger predominantly female population. This study will examine if a remote-exercise programme is achievable in people after a SCAD event.

Full description

Spontaneous coronary artery dissection (SCAD) is a rare condition that leads to myocardial infraction (MI). Young women make up 87-95% of SCAD events, which is also the leading cause of MIs occurring after pregnancy. Following any MI event, cardiovascular rehabilitation (CR) is recommended, which includes supervised exercise sessions, and interventions to reduce risk factors, improve psychosocial wellbeing, and increase medication adherence. Evidence from randomised controlled trials (RCTs) show that CR reduces cardiac events and decreases mortality but this evidence is largely generated in a population with atherosclerotic disease. Trials of CR include mostly male participants, typically aged in their mid-sixties therefore CR guidelines may not be appropriate for the SCAD population who significantly differ in pathophysiology, age and gender compared with the population for which CR has been developed and tested.

Previous observational data suggested an association with strenuous exercise and SCAD, however, no casual link has been established. Clinical advice on exercise following SCAD is conflicting due to the lack of RCTs and therefore evidence. Consequently, many SCAD patients experience psychological distress, fear, and anxiety about exercise, avoiding all exercise which may lead to predictable long-term health consequences. Well-tested recovery programmes in SCAD are required to offer informed and tested exercise-based support to reduce the fear and hesitancy that may lead to exercise avoidance. This is particularly needed for women, who constitute the majority of SCAD diagnoses but are less likely to be referred to, attend, or adhere to CR. Small studies have explored the feasibility of SCAD survivors' participation in CR , however, programmes in these studies used conservative guidance preventing participants to reach pre-morbid exercise levels. This is problematic as (a) if participants are asked to exercise at levels well below their functional capacity, a rehabilitation effect is unlikely (b) such advice potentially reinforces that only lower levels of exercise are safe. This highlights the challenges SCAD survivors have in knowing what is safe and effective in terms of exercise. Therefore, this project aims to improve what we know about exercise and physical activity after SCAD.

The investigators will aim to test if women who have survived a SCAD will take part in a two-arm feasibility randomised controlled study of a 12-week remote exercise programme, what levels of exercise duration and intensity they achieve, and what they think about it. The two-arm design (usual care + blinded wearable activity monitor [control] and exercise intervention, + cardiopulmonary exercise test(CPET), + wearable activity monitor [intervention]) has been chosen to allow for the use of CPET at baseline to ensure safe exercise prescription.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female
  • Aged ≥18 years.
  • Diagnosed with angiographically confirmed SCAD and referred to the Leicester SCAD clinic.
  • Ejection fraction >45%.
  • Blood pressure <180/100. Resting heart rate <100bpm

Exclusion criteria

  • No SCAD diagnosis.
  • Unable to travel to Leicester Hospital for their SCAD clinic appointment.
  • Unable to give informed consent.
  • No smart phone or internet access
  • Unable to understand verbal explanations in English.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Exercise Intervention
Experimental group
Description:
12 week exercise intervention, + cardiopulmonary exercise test (CPET) + wearable activity monitor for the intervention period
Treatment:
Behavioral: Exercise training
Usual care
No Intervention group
Description:
Usual car + blinded activity monitor

Trial contacts and locations

1

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Central trial contact

Noemi Vadaszy, BSc, MSc, PhD

Data sourced from clinicaltrials.gov

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