|- candidate number||23974|
|- NTR Number||NTR5701|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-feb-2016|
|- Secondary IDs||METC-WU (15/35) |
|- Public Title||De effecten van 4 weken training en eiwitsupplementen op spierkracht, spiermassa en conditie in een ongetrainde 55+ populatie|
|- Scientific Title||The effects of short-term exercise and protein supplementation on muscle strength, muscle mass and physical fitness in untrained older adults|
|- hypothesis||Short-term exercise and protein supplementation enhances muscle strength, mass and physical fitness in a group of untrained men and women aged 55-75 years. |
|- Healt Condition(s) or Problem(s) studied||Muscle strength, Older adults|
|- Inclusion criteria||- Aged 55 to 75 years.|
- Not meeting the Dutch Norm for Health-enhancing Physical Activity ('Nederlandse Norm Gezond Bewegen').
- No participation in any structured or regular exercise training programs for the last 3 months.
|- Exclusion criteria||- Allergic or sensitive for milk proteins, or lactose intolerant.|
- Diagnosed with renal insufficiency.
- On a diet which affects protein intake (i.e. advices of an increase, decrease or type of protein (intake)).
- Having known contraindications for exercise.
- Diagnosed with cancer for which currently treated.
- Having a contraindication to MRI scanning (including, but not limited to):
o pacemakers and defibrillators
o intraorbital or intraocular metallic fragments
o ferromagnetic implants
- Participation in another intervention trial.
- Unable to understand Dutch.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mrt-2016|
|- planned closingdate||1-aug-2016|
|- Target number of participants||18|
|- Interventions||All subjects will receive a 4 week intervention program consisting of:|
1) an exercise program (combination of resistance and aerobic exercises during supervised exercise sessions, and a home-based advice)
2) protein supplementation.
|- Primary outcome||The primary outcome of this study is the change in isometric quadriceps strength (Biodex).|
|- Secondary outcome||Secondary parameters are changes in quadriceps muscle mass (MRI and ultrasound), handgrip strength (dynamometer), power of the lower limb (chair rise time test), physical fitness (Åstrand-Rhyming test), habitual physical activity (accelerometer) and daily protein intake (24h recall questionnaire).|
|- Timepoints||Parameters are assessed at baseline, 2 weeks and 4 weeks.|
|- Trial web site||not applicable|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc Margot de Regt|
|- CONTACT for SCIENTIFIC QUERIES||MSc Margot de Regt|
|- Sponsor/Initiator ||Ziekenhuis Gelderse Vallei|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale and objective:|
The aging process and physical inactivity are both clearly linked to low muscle mass, muscle strength and physical fitness. Long-term exercise programs in combination with protein supplementation show improvements in muscle function. However, in some circumstances such as prior surgery, time available to improve person’s muscle function and physical fitness is limited to a few weeks. Therefore, the present study aims to investigate whether an improvement in muscle strength, muscle mass and physical fitness can be achieved within 4 weeks of exercise and protein supplementation in a group of untrained men and women aged 55-75 years.
Single group repeated measures design.
18 untrained men and women aged 55 to 75 years who do not meet the Dutch Norm for Health-enhancing Physical Activity ('Nederlandse Norm Gezond Bewegen').
4 weeks of exercise and protein supplementation
Main study parameters:
Changes in quadriceps strength, quadriceps muscle mass, handgrip strength, power of the lower limb, physical fitness, habitual physical activity and daily protein intake. Parameters are assessed at baseline, 2 weeks and 4 weeks.
|- Main changes (audit trail)|
|- RECORD||16-feb-2016 - 16-apr-2016|