Protein-enriched, milk-based supplement to counteract sarcopenia in acutely ill geriatric patients offered resistance exercise training during and after hospitalisation: study protocol for a randomised, double-blind, multicentre trial
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Protein-enriched, milk-based supplement to counteract sarcopenia in acutely ill geriatric patients offered resistance exercise training during and after hospitalisation : study protocol for a randomised, double-blind, multicentre trial. / Gade, Josephine; Beck, Anne Marie; Bitz, Christian; Christensen, Britt; Klausen, Tobias Wirenfeldt; Vinther, Anders; Astrup, Arne.
In: B M J Open, Vol. 8, No. 2, e019210, 2018.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Protein-enriched, milk-based supplement to counteract sarcopenia in acutely ill geriatric patients offered resistance exercise training during and after hospitalisation
T2 - study protocol for a randomised, double-blind, multicentre trial
AU - Gade, Josephine
AU - Beck, Anne Marie
AU - Bitz, Christian
AU - Christensen, Britt
AU - Klausen, Tobias Wirenfeldt
AU - Vinther, Anders
AU - Astrup, Arne
N1 - CURIS 2018 NEXS 053
PY - 2018
Y1 - 2018
N2 - INTRODUCTION: Age-related loss of muscle mass and strength, sarcopaenia, burdens many older adults. The process is accelerated with bed rest, protein intakes below requirements and the catabolic effect of certain illnesses. Thus, acutely ill, hospitalised older adults are particularly vulnerable. Protein supplementation can preserve muscle mass and/or strength and, combining this with resistance exercise training (RT), may have additional benefits. Therefore, this study investigates the effect of protein supplementation as an addition to offering RT among older adults while admitted to the geriatric ward and after discharge. This has not previously been investigated.METHODS AND ANALYSIS: In a block-randomised, double-blind, multicentre intervention study, 165 older adults above 70 years, fulfilling the eligibility criteria, will be included consecutively from three medical departments (blocks of n=20, stratified by recruitment site). After inclusion, participants will be randomly allocated (1:1) to receive either ready-to-drink, protein-enriched, milk-based supplements (a total of 27.5 g whey protein/day) or isoenergetic placebo products (<1.5 g protein/day), twice daily as a supplement to their habitual diet. Both groups will be offered a standardised RT programme for lower extremity muscle strength (daily while hospitalised and 4×/week after discharge). The study period starts during their hospital stay and continues 12 weeks after discharge. The primary endpoint is lower extremity muscle strength and function (30 s chair-stand-test). Secondary endpoints include muscle mass, measures of physical function and measures related to cost-effectiveness.ETHICS AND DISSEMINATION: Approval is given by the Research Ethic Committee of the Capital Region of Denmark (reference no. H-16018240) and the Danish Data Protection Agency (reference no. HGH-2016-050). There are no expected risks associated with participation, and each participant is expected to benefit from the RT. Results will be published in peer-reviewed international journals and presented at national and international congresses and symposiums.TRIAL REGISTRATION NUMBER: NCT02717819 (9 March 2016).
AB - INTRODUCTION: Age-related loss of muscle mass and strength, sarcopaenia, burdens many older adults. The process is accelerated with bed rest, protein intakes below requirements and the catabolic effect of certain illnesses. Thus, acutely ill, hospitalised older adults are particularly vulnerable. Protein supplementation can preserve muscle mass and/or strength and, combining this with resistance exercise training (RT), may have additional benefits. Therefore, this study investigates the effect of protein supplementation as an addition to offering RT among older adults while admitted to the geriatric ward and after discharge. This has not previously been investigated.METHODS AND ANALYSIS: In a block-randomised, double-blind, multicentre intervention study, 165 older adults above 70 years, fulfilling the eligibility criteria, will be included consecutively from three medical departments (blocks of n=20, stratified by recruitment site). After inclusion, participants will be randomly allocated (1:1) to receive either ready-to-drink, protein-enriched, milk-based supplements (a total of 27.5 g whey protein/day) or isoenergetic placebo products (<1.5 g protein/day), twice daily as a supplement to their habitual diet. Both groups will be offered a standardised RT programme for lower extremity muscle strength (daily while hospitalised and 4×/week after discharge). The study period starts during their hospital stay and continues 12 weeks after discharge. The primary endpoint is lower extremity muscle strength and function (30 s chair-stand-test). Secondary endpoints include muscle mass, measures of physical function and measures related to cost-effectiveness.ETHICS AND DISSEMINATION: Approval is given by the Research Ethic Committee of the Capital Region of Denmark (reference no. H-16018240) and the Danish Data Protection Agency (reference no. HGH-2016-050). There are no expected risks associated with participation, and each participant is expected to benefit from the RT. Results will be published in peer-reviewed international journals and presented at national and international congresses and symposiums.TRIAL REGISTRATION NUMBER: NCT02717819 (9 March 2016).
KW - Study protocol
U2 - 10.1136/bmjopen-2017-019210
DO - 10.1136/bmjopen-2017-019210
M3 - Journal article
C2 - 29391380
VL - 8
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 2
M1 - e019210
ER -
ID: 189321388