Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05924555

Exercise Intolerance Study in Long Chain Fatty Acid Oxidation Disorders

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-08-23

50

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

Sponsors

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead Sponsor

S

Stichting Stofwisselkracht

Collaborating Sponsor

AI-Summary

What this Trial Is About

In this study, the exercise tolerance in patients with long-chain fatty acid oxidation disorders (LcFAOD) will be compared to that of healthy volunteers who are carefully matched in terms of age, sex, BMI and physical activity score. The study aims to assess exercise capacity using cardiopulmonary exercise (CPX) tests and activity monitoring over a 7-day period. The hypothesis of the study is that LcFAOD patients will exhibit greater oxygen debt during short periods of exercise compared to healthy individuals. These findings will contribute to a better understanding of exercise intolerance in LcFAOD patients and may guide the development of targeted interventions, such as exercise training programs and enable the analysis of effectiveness of (new) treatments.

CONDITIONS

Official Title

Exercise Intolerance Study in Long Chain Fatty Acid Oxidation Disorders

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • For LcFAOD patients: confirmed diagnosis of CPT2 deficiency, CACT deficiency, MTP deficiency, VLCAD deficiency, or LCHAD deficiency
  • Healthy control subjects aged 18 years or older
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Recent acute myocardial infarction within 6 months prior to inclusion
  • Uncontrolled arrhythmia or severe conduction disorder causing hemodynamic compromise
  • Presence of implantable pacemaker or cardiac device with complete ventricular pacing
  • Uncontrolled heart failure with hemodynamic compromise
  • Uncontrolled hypertension with systolic BP >150 mmHg and diastolic BP >100 mmHg on repeated measurements
  • Active infection, anemia, severe renal dysfunction (eGFR <30 ml/min/1.73m2), or other chronic diseases impacting exercise performance
  • History of severe asthma or chronic obstructive pulmonary disease
  • Active use of medication likely to affect exercise tolerance
  • For healthy controls: history of smoking, asthma, COPD, heart failure, heart surgery, heart rhythm disorders, or congenital heart diseases
  • Chronic illnesses likely to impact exercise performance including orthopedic, endocrinological, hematological, malignant, gastrointestinal, neurological, muscle, or inflammatory disorders
  • Consumption of more than 6 alcohol units per day or more than 14 alcohol units per week

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

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Research Team

K

Khya Snelder, BSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Exercise Intolerance Study in Long Chain Fatty Acid Oxidation Disorders | DecenTrialz