Milk and resistance exercise intervention to improve muscle function in community-dwelling older adults at risk of sarcopenia (MIlkMAN): protocol for a pilot study

Abstract

IntroductionSarcopenia is a progressive muscle disorder characterised by decline in skeletal muscle mass, strength and function leading to adverse health outcomes, including falls, frailty, poor quality of life and death. It occurs more commonly in older people and can be accelerated by poor diet and low physical activity. Intervention studies incorporating higher dietary protein intakes or protein supplementation combined with resistance exercise (RE) have been shown to limit muscle function decline. However, less is known about the role of whole foods in reducing the risk of sarcopenia. Milk is a source of high-quality nutrients, which may be beneficial for skeletal muscle. This pilot study examines the feasibility and acceptability of milk consumption with RE to improve muscle function in community-dwelling older adults at risk of sarcopenia.Methods and analysis30 older adults aged ≥65 years will be randomly allocated to three groups: ‘whole milk+RE’, ‘skimmed milk+RE’ or ‘control drink+RE’. Assessments will take place in participants’ homes, including screening (milk allergies, grip strength, walking speed), baseline and postintervention health and function. All participants will undertake a structured RE intervention twice a week for 6 weeks at a local gym, followed by the consumption of 500 mL of whole or skimmed milk (each ~20 g of protein) or an isocaloric control drink and another 500 mL at home. Participants’ views about the study will be assessed using standardised open-ended questions. The primary outcomes include feasibility and acceptability of the intervention with recruitment, retention and intervention response rates. Analyses will include descriptive statistics, exploration of qualitative themes and intervention fidelity.Ethics and disseminationOutputs include pilot data to support funding applications; public involvement events; presentation at conferences and peer-reviewed publication.Trial registration number ISRCTN13398279; Pre-results.

Feasibility and acceptability of a milk and resistance exercise intervention to improve muscle function in community-dwelling older adults (MIlkMAN): Pilot study

“…The protocol for the MIlk Intervention Muscle AgeiNg (MIlkMAN) study has been described in detail previously [22]. The study was prospectively registered at https://www.isrctn.com/ ISRCTN13398279 and was reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement extension for reporting randomised pilot and feasibility trials [23].…”

“…We used two-step pre-screening approach. First, prospective participants were pre-screened by primary care practices from their patient databases using inclusion and exclusion criteria outlined in the study protocol [22] (e.g. exclusion: any major metabolic, respiratory, cardiovascular conditions, and mental and physical impairments that would preclude safe participation in the intervention; hip and knee replacement; BMI �30 kg/m 2 ).…”

“…Muscle soreness was evaluated using a Visual Analogue Scale describing the intensity of muscle soreness (e.g. 0 'no pain at all', and 7-10 'the worst pain') at 6-7 h post-exercise [22]. Blood pressure was measured~10 min pre and post-exercise (Omron Healthcare Co., Ltd., Muko, Kyoto, Japan).…”

“…Collection of exploratory pilot data (secondary outcomes) to inform future trials was successful and completed as outlined in the study protocol [22].…”

“…The study has several limitations mostly pertaining to recruitment of the target population, sample size and assessments used in the study, which were discussed in detail in the study protocol [22]. Briefly, to reach the recruitment targets within the proposed timeframe, the study also included participants with no difficulties with day-to-day activities (assessed by SARC-F), and having normal GS and gait speed.…”