Effects of a Combined Physical Training and Protein Supplementation Intervention on Muscle Mass, Functional and Cognitive Performance, and Health-related Quality of Life in the Elderly: a Randomized Controlled Trial.

Study protocol: Acute hospitalised, community-dwelling elderly patients will be recruited at internal medicine service of the Araba University Hospital (HUA). Patients that fulfil eligibility criteria for the study will be evaluated during their hospitalization for different aspects (Hospital Evaluation): handgrip, nutritional assessment using Mini Nutritional Assessment- Short Form Test (MNA-SF), functional assessment by Short Physical Performance Battery (SPPB), cognitive assessment (Pfeiffer test) and frailty assessment (Fried test). Once hospital evaluation is assessed patients will be offered to participate in the study. In case patients accept to participate, another assessment will be carried out on discharge date (Discharge Day Evaluation): handgrip, functional assessment (SPPB), 30-Second Chair Stand Test, 30-Second Arm Curl Test, the Timed Up ang Go (TUG) Test, 8 Foot Up and Go (FUG) Test, Gait Speed Test for 4- meters and for 8-meters. Patients will also take two accelerometers, a wrist accelerometer and a hip accelerometer, for a week.

A week after discharge day, patients will again be evaluated (Laboratory 1 (Lab 1) evaluation day): the same tests of discharge day will be repeated plus Berg Scale and 6-Minute Walking Test. Then, patients will wait until a group of 5-6 participants is formed. As soon as patients accept to participate, and when all evaluation tests involved until Lab 1 evaluation day are completed, participants will be randomized into two different groups: exercise training plus placebo control group (Group 1) and exercise training plus leucine-enriched protein ingestion intervention group (Group 2).

Participants will be called by telephone a week before the intervention starts for psychological assessment, blood analysis and Dual Energy X-ray Absorptiometry (DEXA) assessment.

The first day of intervention program all participants will be evaluated for nutritional assessment: Mini Nutritional Assessment (MNA) Test, a quantitative score (14-item) of adherence to the Mediterranean diet (Prevention with Mediterranean Diet (PREDIMED) questionnaire), two non-consecutive 24-hour dietary recall and anthropometry.

Exercise training intervention will be divided into supervised intervention and non-supervised intervention for both groups. Supervised intervention program will take 12 weeks and participants will have to assist 2 non-consecutive days per week to hospital for 1-hour exercise training. After those 12 weeks participants will take two accelerometers, a wrist accelerometer and a hip accelerometer, for a week. After that week participants will have to assist 2 non-consecutive days on the same week to complete: the same physical tests of Lab 1 evaluation day, anthropometry and nutritional tests, blood analysis and DEXA assessment. Individualised physical exercise recommendations will be explained and given to participants for the following 12 weeks of non-supervised intervention. During those weeks of non-supervised intervention, telephone monitoring will be made every two weeks.