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Recruiting NCT07526766

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

No phase Interventional Fibromuscular Dysplasia Spontaneous Coronary Artery Dissection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic and resistance exercises.
Who it may be relevant to
Registry conditions: Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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.

Overview

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

  • Behavioral Aerobic 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 m

Primary outcome measures

  • Change in blood pressure in response to aerobic exercise [Time frame: Baseline, 5 minutes, 25 minutes, 50 minutes and 55 minutes]
  • Dartmouth COOP Functional Assessment Chart score [Time frame: Baseline]
  • Duke Activity Index Status (DASI) score [Time frame: Baseline]
  • International Physical Activity Questionnaire Short Form (IPAQ-SF) score [Time frame: Baseline]
  • Change in perceived exertion [Time frame: Baseline, 25 minutes, and 50 minutes]
  • Change in blood lactate concentration [La-]b [Time frame: Baseline, 25 minutes, and 50 minutes]

Eligibility criteria

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

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT07526766 · 25-011057

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗