Bispbebjerg Hospital
Copenhagen NV, 2400, Denmark
NCT Number: NCT02105922
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Copenhagen NV, 2400, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Supervised Heavy Resistance Training three times weekly for 3 months.
Home-based Light Intensity Training three-five times weekly for 3 months.
Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.
Time frame: Baseline, 3 months
MRi scans of quadriceps muscle cross sectional area. The statistical evaluation of the primary outcome measure is done by applying a two way ANOVA test comparing groups: 1) Heavy Resistance Training vs. Light Intensity Training vs. Protein Whey. The statistical evaluation will be performed first as an intension-to-treat analysis and subsequently as a per-protocol analysis.
Time frame: Baseline, 3 months
Isometric unilateral quadriceps force and rate of force development measured in the isokinetic dynamometer device (KinCom) during knee extension at the knee angle 70 deg (with 0 degrees being fully extended).
Time frame: Baseline, 3 months
Unilateral knee extension (concentric) strength measured in the KinCom device at an angular velocity of 60 degrees/sec.
Time frame: Baseline, 3 months
Unilateral leg extension power measured in the Powerrig device.
Time frame: Baseline and 3 months
From muscle biopsies muscle fiber type distribution and size, capillary density, satellite cell count and activity, selected gene-expression targets and protein concentrations will be assessed.
Time frame: Baseline, 3 months
Number of stand-ups from a chair in 30 seconds.
Time frame: Baseline, 3 months
Body composition (fat mass, lean mass and bone mass) evaluated by whole-body dual energy x-ray absorptiometry (DXA)-scanning.
Bone mineral density at dominant collum femoris and vertebrae L2-L4 evaluated by DXA-scanning.
Time frame: Baseline, 3 months
Blood: HbA1c, plasma lipids. Anthropometry: Weight, abdominal circumference. Blood pressure.
Time frame: Baseline, 3 months
400 m gait speed.
Time frame: Baseline, 3 months
Isometric hand grip strength.
Time frame: Baseline, 3 months
Short Form 36
Time frame: Baseline, 3 months
Evaluated by 4 days continuous monitoring by a pedometer device (ActivPal).
Time frame: Baseline, 1,5 months
4-days self-report of food and beverage intake.
Bispebjerg Hospital
Other
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