Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection
Conditions
Brief summary
The purpose of this study is to assess the cardiopulmonary, hemodynamic, and symptom responses to acute bouts of varying intensity aerobic and resistance exercise in people with Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD).
Interventions
BEHAVIORALAerobic and resistance exercises
Subjects will undergo three exercise tests, each separated by at least 48 hours: * Symptom-limited cardiopulmonary exercise test (CPET): Patients will cycle upright starting at 0W (3 min) before the workload is increased by 10-35W·min-1 in a ramp fashion (like cycling up a progressively steeper hill) until volitional exhaustion for the determination of V̇O2peak and Wpeak * Two-stage submaximal constant power exercise test: Following a 5-minute warm-up (10-20 W), participants will cycle in the moderate intensity domain for 25 minutes followed by 25 minutes in the heavy intensity domain. * Six different resistance exercises of varying intensities: Participants will perform three sets of six different resistance exercises: chest press; lateral raises; abdominal crunches; planks; leg press; weighted lunges
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* History of Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD), ≥2 months post-event, and free from chest pain. * Able to provide written informed consent
Exclusion criteria
* Individuals who are clinically obese (BMI ≥36) and/or who suffer from musculoskeletal or other conditions that would limit exercise participation. * Individuals who are deemed medically unstable * Participants who are unable to comply with study requirements. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure in response to aerobic exercise | Baseline, 5 minutes, 25 minutes, 50 minutes and 55 minutes | Systemic blood pressure will be measured at rest, at peak exercise, and for 5 minutes of recovery after exercise via finger photoplethysmography and reported as mmHg |
| Dartmouth COOP Functional Assessment Chart score | Baseline | The Dartmouth COOP Functional Assessment Charts are a set of patient-reported, pictorial tools used to measure physical, mental, and social functioning. The tool includes 9 questions that are rated on scores from 1-5, with higher scores indicating worse function. |
| Duke Activity Index Status (DASI) score | Baseline | The Duke Activity Status Index (DASI) is a self-administered questionnaire that measures a patient's functional capacity. It consists of 12 yes/no questions. Scores range from 0 to 58.2, with higher scores indicating better exercise capacity. |
| International Physical Activity Questionnaire Short Form (IPAQ-SF) score | Baseline | The International Physical Activity Questionnaire Short Form (IPAQ-SF) is a 7-item self-reported questionnaire where subjects report time spent being physically active in the last 7 days reported hours per day or minutes per day. |
| Change in perceived exertion | Baseline, 25 minutes, and 50 minutes | Perceived exertion (breathlessness and leg fatigue) will be obtained using the Borg 0-10 scale. |
| Change in blood lactate concentration [La-]b | Baseline, 25 minutes, and 50 minutes | Blood lactate concentration \[La-\]b will be measured via analysis of a pinprick point-of-care lactate test (via the earlobe) at rest, every 2 minutes during exercise, and at peak exercise. |
Countries
United States
Contacts
CONTACTArmia R. Habil, MD
PRINCIPAL_INVESTIGATORElizabeth H. Dineen, DO
Mayo Clinic
Outcome results
None listed