Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection

Official title

Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection- a Feasibility Study

Overview

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.

Interventions

• Behavioral Exercise training
  12 week exercise intervention + cardiopulmonary exercise test (CPET) + wearable activity monitor

Primary outcome measures

• 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).]
• Adherence [Time frame: At week 8 (56 days) of the intervention.]
• Acceptability [Time frame: At 24 (168 days) of the intervention (this is follow up time point three (T3)).]
• 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).]
• 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).]

Secondary outcome measures (12)

• 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United Kingdom · 1 center

• University Hospitals of Leicester — Leicester

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. PMID 33657530
• Neubeck 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. PMID 35290455
• Silber 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. PMID 25730096
• Imran 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. PMID 33884107
• Chou 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. PMID 26923234
• Sawan 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. PMID 35150655
• Supervia 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. PMID 28365100
• Binnie 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. PMID 36656922

Identifiers

NCT: NCT06955663 · 1018 · SCOT23-100002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗