Skeletal Muscle Metabolism during Rest, Exercise and Recovery in Patients with Cystic Fibrosis and Healthy Controls
- Conditions
- mucoviscidosis1002830210010613
- Registration Number
- NL-OMON36204
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Patients with CF:
- Ambulant patients with CF
- free from acute pulmonary or gastro-intestinal exacerbation
- from 12 to 18 years
Healthy controls:
- from 12 to 18 years
- free from constraints in performing a maximal exercise test
Patients with CF:
- Resting oxygen saturation (SpO2)< 94%
- FEV1predicted < 80%
- Ineligible to perform an exercise test
- Not familiar with the Dutch language
- Presence of contra-indications for 31P MRS measurements (assessed by a standardised questionnaire as previously used in METC 08-267/K)
- Participation in DO-IT or having participated less than six months ago in DO-IT (METC 09-114/K);Healthy controls:
- Ineligible to perform a maximal exercise test (assessed by a standardised questionnaire as previously used in METC 10-468)
- Not familiar with the Dutch language
- Presence of contra-indications for 31P MRS measurements (assessed by a standardised questionnaire as previously used in METC 08-267/K)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- * time of PCr recovery (31P MRS)<br /><br>- Resting, exercise and recovery phoscreatine (PCr)(31P MRS)<br /><br>- Resting, exercise and recovery Inorganic phosphorus (Pi)(31P MRS)<br /><br>- Resting, exercise and recovery Pi:PCr ratio(31P MRS)<br /><br>- Resting, exercise and recovery (Adenosine triphosphate) ATP(31P MRS)<br /><br>- Resting, exercise and recovery ATP:PCr ratio(31P MRS)Change in concentration<br /><br>deoxygenated hemoglobin. (NIRS)<br /><br>- Change in concentration oxygenated hemoglobin. (NIRS)<br /><br>- Change in concentration total hemoglobin. (NIRS)<br /><br>- Change in concentration deoxygenated hemoglobin minus change in concentration<br /><br>oxygenated hemoglobin. (NIRS)<br /><br>- The T1/2 (s) change in oxygenated hemoglobin in the recovery phase. (NIRS)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Peak workload (Wpeak)<br /><br>- Resting and peak oxygen uptake (VO2peak/kg (ml.min-1.kg-1) )<br /><br>- Resting and peak minute ventilation (VEpeak) (l.min-1)<br /><br>- Resting and peak respiratory exchange ratio (RER = VCO2/VO2)<br /><br>- Resting and peak heart rate (HR; bpm)<br /><br>- Resting and peak SpO2</p><br>