Sarcopenia Clinical Trial
Official title:
Effect of Strength Training and Protein Ingestion in Old Versus Very-old
From 3 interventiongroups in the project with ClinicalTrials.gov ID NCT02034760, namely:
HRTW: Heavy Strength Training x3/week & 20g whey protein twice daily. LITW: Light Intensity
Training x3-5/week & 20g whey protein twice daily. WHEY: 20g whey protein twice daily.
15 subjects from each group will be recruited and tested after 3 months of intervention.
Tests will include muscle cross sectional area (MRi), muscle biopsies (fiber types, size,
cell- and capillary count), functional- and strength measurements, plasma lipids, HbA1c.
Tests are to be compared with Project ID NCT01997320.
In- and exclusion criteria are listed in NCT02034760. Subjects will be randomized to
interventions as described, and 15 subjects from each of the three groups will be tested
after 12 weeks of intervention.
15 subjects are included in each group to account for an expected drop-out rate of 20%, and
so 12 subjects are expected to complete each intervention. With this N an increase of around
11% in MRi-evaluated muscle size can be detected with a powerlevel of 80% and an alpha of
0.05 and use of reported SD.
Primary outcome is muscle size (MRi), and secondary outcomes are overall body composition
(DXA), muscle strength, rate of force development, power, 30s chair stand, 400m gait speed,
grip strength. Tertiary outcomes are habitual activitylevel (accelerometry), blood samples
(HbA1c, cholesterols, creatinine), blood pressure, weight, BMI, wast- and hip circumference.
Results are to be compared with NCT01997320 and so a population of 65+ can be compared with a
population of 83+. Both studies uses the same heavy strength training regimen.
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