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

Abstract

IntroductionAge-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 analysisIn 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 disseminationApproval 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 numberNCT02717819 (9 March 2016).

Impact of Nutrition Therapy and Rehabilitation on Acute and Critical Illness: A Systematic Review

“…We were unable to obtain trials that were still unpublished or in press or were not published in the English language. Based on this information, critical outcomes may be overturned by future studies, like an ongoing RCT [35]. Continuous surveys and monitoring are required.…”

Protein supplementation combined with low-intensity resistance training in geriatric medical patients during and after hospitalisation: a randomised, double-blind, multicentre trial

“…Approval was given by the Research Ethic Committee of the Capital Region of Denmark (H-16018240), the Danish Data Protection Agency (HGH-2016-050), and the study is registered and available in the clinical.trial.gov database (NCT02717819, registered 9 March 2016). Furthermore, a study protocol has been published, verifying adherence to original intent (27) . Participants did not have any cost associated with participation, and informed consent was signed before enrolment.…”

“…The eligibility criteria are summarised in Table 1. The published study protocol can be referred to for more details about the methods (27) .…”

“…Intervention products. Participants allocated to the protein group received a protein-enriched, milk-based supplement (Protino, Arla Foods ® : 2120 kJ, 27•5 g protein (25 g whey/ 2•5 g casein), 27•5 g fat, 37•5 g carbohydrate and 2•8 μg vitamin D per 250 ml) (refer to the published study protocol, online Supplementary Table S1 in Gade et al (27) , for amino acid profile of the intervention product). Participants allocated to the placebo group received an isoenergetic placebo beverage (Arla Foods ® : 2108 kJ, 1•5 g protein, 26•9 g fat, 63•9 g carbohydrate per 250 ml) developed specifically for the present study.…”

“…The exercises existed in five different modes (A-B-C-D-E), graduated in terms of increasing resistance, by applying the participants' own body weight and different starting positions (refer to the published study protocol, online Supplementary Fig. S1 in Gade et al (27) , for illustrated exercises). Daily supervised RT was offered in addition to the standard care during hospital admission.…”