An interventional study of Exercise training in Spontaneous Coronary Artery Dissection, sponsored by University of Leicester. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University of Leicester · Not applicable, Interventional, and Supportive care
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.
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.
2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 2,118 interventional studies indexed under Motor Activity.
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Exclusion Criteria:
12 week exercise intervention, + cardiopulmonary exercise test (CPET) + wearable activity monitor for the intervention period
Behavioral: Exercise training
Usual car + blinded activity monitor
12 week exercise intervention + cardiopulmonary exercise test (CPET) + wearable activity monitor
Recruitment rate
Rate of successful recruitment
Time frame: From initial patient identification until the patient consents to be part of the study. This may take up to 14 days (from initial approach until full informed consent is obtained).
Adherence
Rate of successful adherence
Time frame: At week 8 (56 days) of the intervention.
Acceptability
Acceptability of the intervention assessed via qualitative interviews which will be then transcribed verbatim. Acceptability will be assessed via thematic analysis of semi-structured interviews. Once patients completed T3 (+/- 7 days), they will be invited to take part in semi-structured interviews.
Time frame: At 24 (168 days) of the intervention (this is follow up time point three (T3)).
Signal of efficacy: Changes in exercise duration
Changes in exercise duration expressed in time (hours: minutes) measured by the activity monitor(s) over the study period.
Time frame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Signal of efficacy: Changes in exercise intensity
Changes in exercise intensity expressed in period(s) of time spent (hours: minutes) performing light, moderate, and/or heavy intensity exercise.
Time frame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Self-efficacy: Self-efficacy questionnaire
Self-reported self-efficacy levels via the self-efficacy questionnaire. This questionnaire uses a 10-item Likert scale, where minimum score is 1 (not at all true) and the maximum score is 4 (exactly true). The overall score range therefore is 10-40 where higher scores indicate better self-efficacy.
Time frame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Chest pain: Seattle Angina Questionnaire-7
Self-reported chest pain via the Seattle Angina Questionnaire-7 (SAQ-7) uses a four week recall period therefore the scores can be translated into frequency of angina symptoms 0-30=daily angina, 31-60=weekly angina, 61-99=monthly angina and 100=no angina). The summary score range from 0 to 100 with higher scores indicating less angina and overall better quality of life.
Time frame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Wellbeing: Warwick Edinburgh Mental Wellbeing Scale
Self-reported wellbeing via the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). This is a 14-item Likert scale questionnaire with 5 response categories (1=None of the time to 5=All of the time). The total score can range from 14-70, where higher scores indicate better wellbeing.
Time frame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Anxiety: Generalised Anxiety Disorder
Self-reported general anxiety levels will be assessed via the Generalised Anxiety Disorder questionnaire (GAD-7). The GAD-7 scores each item in a Likert-scale fashion, where 'Not at all' is scored as '0', 'Several days in scored as '1' , 'More than half the days' is scored as '2' and 'Nearly every day' is scored as '3'. Higher values indicate more severe anxiety (where maximum score is 21). The data then can be categorised into the following: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety.
Time frame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Anxiety: Cardiac Anxiety Questionnaire
Self-reported cardiac related questionnaire, which assesses cardiac anxiety via 18 items in a Likert-scale fashion. Items are scored from 0-4 where 'Never' is scored as '0', 'Rarely' is scored as '1' , 'Sometimes' is scored as '2' , 'Often' is scored as '3' and 'Always' is scored as '4'. Higher scores indicate more severe anxiety where the minimum score is 0 and the maximum is 72.
Time frame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Demographic and health data: Age
Age expressed in years
Time frame: At baseline/Day 1 (T1).
Demographic and health data: Sex
Sex assigned at birth expressed as: Female, Male or Prefer not to answer.
Time frame: At baseline/Day 1 (T1).
Demographic and health data: Ethnicity
Categorical self-reported data defined as the following: * White * Gypsy or Irish Traveller * White and Black Caribbean * White and Black African * White and Asian * Indian * Pakistani * Bangladeshi * Chinese * African * Caribbean * Arab * Any other ethnic group (please describe) * Prefer not to answer.
Time frame: At baseline/Day 1 (T1).
Demographic and health data: Number of Spontaneous Coronary Dissection (SCAD) events
Self-reported numbers of Spontaneous Coronary Dissection (SCAD) events.
Time frame: At baseline/Day 1 (T1).
Demographic and health data: Smoking status
Self-reported smoking status defined as 'Current smoker', 'Previous smoker' and/or 'Never smoked'
Time frame: At baseline/Day 1 (T1).
Physical activity: International Physical Activity Questionnaire - short version
Self-reported measure of momentary physical activity levels. Participants are asked to recall habitual physical activity levels (of all intensities such as vigorous, moderate activities and walking) from the past 7 days. Participants are requested to quantify time spent performing these activities in days, hours and minutes. Participants are also asked to report on sedentary time. A finals scores is then calculated and expressed in the metabolic equivalent of task (MET) minutes per week (MET/min/week).
Time frame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Physical function: 6 Minute Walk Test
Self-reported distance achieved in the 6-minute walk test administered using the Timed Walk App. Participants are requested the distance (in metres) they walked over 6 minutes.
Time frame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Physical function: Sit to stand test
Participants are requested to report the number of repetitions (count data) of sit to stands over half a minute (30 seconds).
Time frame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Plan to share: No — This is a single site feasibility study as such we aim to gather a relatively small amount of data at one hospital site within the UK. The Principal Investigator of the study is the same medical doctor as the Principal Investigator at the hospital site therefore it is unlikely that IPD will need to be shared. Pseudonymised datasets may be shared with collaborating partners in the future.
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Coronary Artery Dissection, Spontaneous
University of Leicester