A Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia

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 21 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Cardiopulmonary, Hemodynamic, And Symptom Responses To Aerobic And Resistance Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia: A Single-center, Single-arm Prospective Clinical Trial.

Conditions

Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection

Being tested

Aerobic and resistance exercises

Medical subject headings

Fibromuscular Dysplasia, Coronary Artery Dissection, Spontaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Aerobic and resistance exercisesBehavioural

  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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   Measured: Baseline, 5 minutes, 25 minutes, 50 minutes and 55 minutes

2. 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.

   Measured: Baseline

3. 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.

   Measured: Baseline

4. 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.

   Measured: Baseline

5. Change in perceived exertion

   Perceived exertion (breathlessness and leg fatigue) will be obtained using the Borg 0-10 scale.

   Measured: Baseline, 25 minutes, and 50 minutes

6. Change in blood lactate concentration [La-]b

   Blood lactate concentration [La-]b will be measured via analysis of a pinprick point-of-care lactate test (via the earlobe) at rest, during exercise, and at peak exercise.

   Measured: Baseline, 25 minutes, and 50 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted13 Apr 2026
2. Study start1 Sep 2026
3. Primary completion30 Aug 2027 (estimated)
4. Study completion1 Nov 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Fibromuscular DysplasiaStudies of the same condition, open and under way.
• More trials run by Mayo ClinicThe sponsor's other registered studies.
• 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.