Effectiveness of a muticomponent workout program integrated in an evidence based multimodal program in hyperfrail elderly patients: POWERAGING randomized clinical trial protocol

BACKGROUND: Short-term and mid-term comparison of the efficacy of a multimodal program that incorporates a therapeutic workout program, medication review, diet adjustment and health education, in comparison to the standard medical practice in the improvement of the neuromuscular and physiological condition. Furthermore, it is intended to analyse the maintenance of these effects in a long-term follow-up (12 months) from the onset of the intervention. METHODS: A randomized clinical trial of elderly frail patients drawn from the Clinical Management Unit “Tiro de Pichón”, Health District of Malaga, will be included in the study (after meeting the inclusion / exclusion criteria) will be randomized in two groups: a control group that will undergo an intervention consistent of medication review + diet adjustment + health education (regular workout recommendations within a complete advice on healthy lifestyles) and an experimental group whose intervention will consist of a multimodal treatment: therapeutic workout program+ medication review+ diet adjustment + health education. The sociodemographic, clinical and tracing variables will be reflected at the beginning of the study. In addition, the follow-up variables will be gathered at the second and sixth months after the beginning of the treatment and at the third and sixth months after the treatment (follow-up). The follow-up variables that will be measured are: body mass index, general health condition, fatigue, frailty, motor control, attention- concentration- memory, motor memory, spatial orientation, grip strength, balance (static, semi-dynamic), gait speed and metabolomics. A descriptive analysis of the sociodemographic variables of the participants will be conducted. One-Factor ANOVA will be used for the Within-Subject analysis and as for the Between-Subject analysis, the outcome variables between both the groups in each moment of the data collection will be compared. DISCUSSION: A multimodal program that incorporates a therapeutic workout program, medication review, diet adjustment and health education may be effective treatment to reduce the functional decline in elderly. The results of the study will provide information on the possible strengths and benefits in multimodal program in elderly. TRIAL REGISTRATION: ClinicalTrials.gov NCT02772952 registered May 2017.