A Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorMayo Clinic
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Aerobic and resistance exercises
BehavioralSubjects 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
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Aerobic and resistance exerciseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in blood pressure in response to aerobic exercise
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
Time frame
Baseline, 5 minutes, 25 minutes, 50 minutes and 55 minutes2
Dartmouth COOP Functional Assessment Chart score
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.
Time frame
Baseline3
Duke Activity Index Status (DASI) score
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.
Time frame
Baseline4
International Physical Activity Questionnaire Short Form (IPAQ-SF) score
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov