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The effects of cholesterol-lowering medication on exercise performance.


- candidate number27081
- NTR NumberNTR6346
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-apr-2017
- Secondary IDs2016-2867 NL59192.091.16
- Public TitleThe effects of cholesterol-lowering medication on exercise performance.
- Scientific TitleThe effects of statins on exercise performance.
- ACRONYMSTATEX
- hypothesisWe hypothesize that improving both the quantity and quality of the mitochondria by exercise training may counteract the statin-induced myocellular changes, and optimize muscle function and overall exercise capacity.
- Healt Condition(s) or Problem(s) studiedStatin, Physical activity, Excercise capacity, Mitochondrail function, Muscle toxicity
- Inclusion criteria3 study groups:
1. Statin users with self-reported muscle symptoms
2. Statin users without muscle symptoms or other side effects
3. A control group, not using any statins

Inclusion criteria
- Males and females aged 40 to 70 years.
- Mentally able to give informed consent.
- Current statin user (group 1-2) for at least 3 months
- Exclusion criteria- Familial hypercholesterolemia
- History of cardiovascular event within 1 year of study participation
- Known hereditary muscle defect
- Known mitochondrial disease
- Diabetes Mellitus
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 17-apr-2017
- planned closingdate1-apr-2020
- Target number of participants72
- InterventionsCombined endurance and resistance training program
- Primary outcome- Exercise-induced change in aerobic fitness
- Exercise-induced change in mitochondrial mass and function and substrate use
- Secondary outcome- Exercise-induced change in muscle strength, contractile function and fatigue, and muscle mass
- Exercise-induced change in pain- and fatigue rating, and quality of life
- TimepointsAll measurements are performed before exercise training and after 12 weeks of exercise training.
- Trial web sitehttp://www.ccmo.nl/nl/erkende-metc-s/cmo-regio-arnhem-nijmegen
- statusplanned
- CONTACT FOR PUBLIC QUERIES Eline Allard
- CONTACT for SCIENTIFIC QUERIES Eline Allard
- Sponsor/Initiator Radboud university medical center, Department of Physiology
- Funding
(Source(s) of Monetary or Material Support)
Radboud university medical center, Department of Physiology
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD12-apr-2017 - 1-jun-2017


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