Spontaneous Coronary Artery DissectionEXERCISE-SCADNCT06955663
Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection
A study testing Exercise training in people with Spontaneous Coronary Artery Dissection, run by University of Leicester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spontaneous Coronary Artery Dissection
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Leicester
Leicester, Leicestershire, LE3 9QP
Noemi Vadaszy, BSc MSc PhD, + 44 116 258 2838, nv96@leicester.ac.uk
David Adlam, BA BM BCh DPhil FRCP FESC
About this study
Official title: Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection- a Feasibility Study
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.
Read the detailed 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.
- Conditions
- Spontaneous Coronary Artery Dissection
- Being tested
- Exercise training
- Keywords
- Sponaneous coronary artery dissection, Exercise, Randomised controlled trial, Rehabilitaiton, Fesability
- Medical subject headings
- Coronary Artery Dissection, Spontaneous, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
12 week exercise intervention + cardiopulmonary exercise test (CPET) + wearable activity monitor
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | 12 week exercise intervention, + cardiopulmonary exercise test (CPET) + wearable activity monitor for the intervention period Receives: Behavioral: Exercise training |
| Usual care | No intervention | Usual car + blinded activity monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Rate of successful recruitment
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At baseline/Day 1 (T1).
Demographic and health data: Sex
Sex assigned at birth expressed as: Female, Male or Prefer not to answer.
Measured: 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.
Measured: 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.
Measured: 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'
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 May 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Coronary Artery DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, Edinburgh Napier University
- Responsible party
- Sponsor
- Investigators
- David Adlam, BA BM BCh DPhil FRCP FESC, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955663
- Sponsor's protocol ID
- 1018
- Other IDs
- SCOT23-100002
- Acronym
- EXERCISE-SCAD
- Status last verified
- May 2026
- First submitted
- 15 Apr 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Hanson CL, Kelly P, Neubeck L, Bell J, Gibb H, Jin K. The Contribution of Leisure Center Usage to Physical Activity in the United Kingdom: Evidence From a Large Population-Based Cohort. J Phys Act Health. 2021 Mar 3;18(4):382-390. doi: 10.1123/jpah.2020-0422. Print 2021 Apr 1.
PubMed 33657530Neubeck L, McHale S, Ross M, MacGillivray S, Galbraith M, Hanson C. Spontaneous coronary artery dissection: a systematic review of physical and psychosocial recovery following discharge from hospital. Eur J Cardiovasc Nurs. 2022 Oct 14;21(7):665-676. doi: 10.1093/eurjcn/zvac009.
PubMed 35290455Silber TC, Tweet MS, Bowman MJ, Hayes SN, Squires RW. Cardiac rehabilitation after spontaneous coronary artery dissection. J Cardiopulm Rehabil Prev. 2015 Sep-Oct;35(5):328-33. doi: 10.1097/HCR.0000000000000111.
PubMed 25730096Imran H, Gaw A, Stabile L, Shah N, Choudhary G, Wu WC. Safety and Outcomes of Cardiac Rehabilitation for Patients with Spontaneous Coronary Artery Dissection. J Rehabil Med Clin Commun. 2018 May 23;1:1000001. doi: 10.2340/20030711-1000001. eCollection 2018.
PubMed 33884107Chou AY, Prakash R, Rajala J, Birnie T, Isserow S, Taylor CM, Ignaszewski A, Chan S, Starovoytov A, Saw J. The First Dedicated Cardiac Rehabilitation Program for Patients With Spontaneous Coronary Artery Dissection: Description and Initial Results. Can J Cardiol. 2016 Apr;32(4):554-60. doi: 10.1016/j.cjca.2016.01.009. Epub 2016 Jan 18.
PubMed 26923234Sawan MA, Calhoun AE, Fatade YA, Wenger NK. Cardiac rehabilitation in women, challenges and opportunities. Prog Cardiovasc Dis. 2022 Jan-Feb;70:111-118. doi: 10.1016/j.pcad.2022.01.007. Epub 2022 Feb 10.
PubMed 35150655Supervia M, Medina-Inojosa JR, Yeung C, Lopez-Jimenez F, Squires RW, Perez-Terzic CM, Brewer LC, Leth SE, Thomas RJ. Cardiac Rehabilitation for Women: A Systematic Review of Barriers and Solutions. Mayo Clin Proc. 2017 Mar 13:S0025-6196(17)30026-5. doi: 10.1016/j.mayocp.2017.01.002. Online ahead of print.
PubMed 28365100Binnie K, Neubeck L, McHale S, Hanson CL. What do spontaneous coronary artery dissection survivors want to support their recovery? a qualitative study. Eur J Cardiovasc Nurs. 2023 Dec 14;22(8):814-823. doi: 10.1093/eurjcn/zvad013.
PubMed 36656922Bouchard K, Tarannum CN, Coutinho T, So D, Tulloch H. Secondary Preventative Care for Patients After Spontaneous Coronary Artery Dissection: A Qualitative Analysis of Health Care Providers' Perspectives. Can J Cardiol. 2020 Jul;36(7):1156-1160. doi: 10.1016/j.cjca.2019.11.004. Epub 2019 Nov 11.
PubMed 32247705Bouchard K, Coutinho T, Reed J, Lalande K, Tarannum CN, So D, Saw J, Mulvagh S, Tulloch H. Recovering from spontaneous coronary artery dissection: Patient-reported challenges and rehabilitative intervention needs. Health Psychol. 2021 Jul;40(7):472-479. doi: 10.1037/hea0001086.
PubMed 34435799Saw J, Aymong E, Sedlak T, Buller CE, Starovoytov A, Ricci D, Robinson S, Vuurmans T, Gao M, Humphries K, Mancini GB. Spontaneous coronary artery dissection: association with predisposing arteriopathies and precipitating stressors and cardiovascular outcomes. Circ Cardiovasc Interv. 2014 Oct;7(5):645-55. doi: 10.1161/CIRCINTERVENTIONS.114.001760. Epub 2014 Oct 7.
PubMed 25294399Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.
PubMed 26764059Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Angelantonio ED, Franco OH, Halvorsen S, Richard Hobbs FD, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: Developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). Rev Esp Cardiol (Engl Ed). 2022 May;75(5):429. doi: 10.1016/j.rec.2022.04.003. No abstract available. English, Spanish.
PubMed 35525570
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection- a Feasibility Study
- ClinicalTrials.gov ID
- NCT06955663
- Acronym / sponsor ID
- EXERCISE-SCAD / 1018
- Conditions
- Spontaneous Coronary Artery Dissection
- Keywords
- Sponaneous coronary artery dissection, Exercise, Randomised controlled trial, Rehabilitaiton, Fesability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, Edinburgh Napier University
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise training12 week exercise intervention, + cardiopulmonary exercise test (CPET) + wearable activity monitor for the intervention period |
| Usual care | No intervention | –Usual car + blinded activity monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training12 week exercise intervention + cardiopulmonary exercise test (CPET) + wearable activity monitor | Behavioural | Exercise Intervention |
Primary outcome
Recruitment rate
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).
Rate of successful recruitment
Adherence
Time frame: At week 8 (56 days) of the intervention.
Rate of successful adherence
Acceptability
Time frame: At 24 (168 days) of the intervention (this is follow up time point three (T3)).
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.
Signal of efficacy: Changes in exercise duration
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).
Changes in exercise duration expressed in time (hours: minutes) measured by the activity monitor(s) over the study period.
Signal of efficacy: Changes in exercise intensity
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).
Changes in exercise intensity expressed in period(s) of time spent (hours: minutes) performing light, moderate, and/or heavy intensity exercise.
13 secondary outcomes
Self-efficacy: Self-efficacy questionnaire
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
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
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
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
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
Time frame: At baseline/Day 1 (T1).
Demographic and health data: Sex
Time frame: At baseline/Day 1 (T1).
Demographic and health data: Ethnicity
Time frame: At baseline/Day 1 (T1).
Demographic and health data: Number of Spontaneous Coronary Dissection (SCAD) events
Time frame: At baseline/Day 1 (T1).
Demographic and health data: Smoking status
Time frame: At baseline/Day 1 (T1).
Physical activity: International Physical Activity Questionnaire - short version
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
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
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 33657530Hanson CL, Kelly P, Neubeck L, Bell J, Gibb H, Jin K. The Contribution of Leisure Center Usage to Physical Activity in the United Kingdom: Evidence From a Large Population-Based Cohort. J Phys Act Health. 2021 Mar 3;18(4):382-390. doi: 10.1123/jpah.2020-0422. Print 2021 Apr 1.
- Background: PubMed 35290455Neubeck L, McHale S, Ross M, MacGillivray S, Galbraith M, Hanson C. Spontaneous coronary artery dissection: a systematic review of physical and psychosocial recovery following discharge from hospital. Eur J Cardiovasc Nurs. 2022 Oct 14;21(7):665-676. doi: 10.1093/eurjcn/zvac009.
- Background: PubMed 25730096Silber TC, Tweet MS, Bowman MJ, Hayes SN, Squires RW. Cardiac rehabilitation after spontaneous coronary artery dissection. J Cardiopulm Rehabil Prev. 2015 Sep-Oct;35(5):328-33. doi: 10.1097/HCR.0000000000000111.
- Background: PubMed 33884107Imran H, Gaw A, Stabile L, Shah N, Choudhary G, Wu WC. Safety and Outcomes of Cardiac Rehabilitation for Patients with Spontaneous Coronary Artery Dissection. J Rehabil Med Clin Commun. 2018 May 23;1:1000001. doi: 10.2340/20030711-1000001. eCollection 2018.
- Background: PubMed 26923234Chou AY, Prakash R, Rajala J, Birnie T, Isserow S, Taylor CM, Ignaszewski A, Chan S, Starovoytov A, Saw J. The First Dedicated Cardiac Rehabilitation Program for Patients With Spontaneous Coronary Artery Dissection: Description and Initial Results. Can J Cardiol. 2016 Apr;32(4):554-60. doi: 10.1016/j.cjca.2016.01.009. Epub 2016 Jan 18.
- Background: PubMed 35150655Sawan MA, Calhoun AE, Fatade YA, Wenger NK. Cardiac rehabilitation in women, challenges and opportunities. Prog Cardiovasc Dis. 2022 Jan-Feb;70:111-118. doi: 10.1016/j.pcad.2022.01.007. Epub 2022 Feb 10.
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- Background: PubMed 36656922Binnie K, Neubeck L, McHale S, Hanson CL. What do spontaneous coronary artery dissection survivors want to support their recovery? a qualitative study. Eur J Cardiovasc Nurs. 2023 Dec 14;22(8):814-823. doi: 10.1093/eurjcn/zvad013.
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- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Adlam, BA BM BCh DPhil FRCP FESC principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Spontaneous Coronary Artery Dissection, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noemi Vadaszy, BSc, MSc, PhD (+ 44 116 258 3828, nv96@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06955663, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.