Physical Activity Clinical Trial
Official title:
Effectiveness of a Multi-componentphysical Training Integrated Into a Multimodal Program Based on the Evidence in Hiper-fragile Elders: A Randomized Clinical Trial STUDY POWER_AGING
Objective: To compare short-term and medium-term effectiveness of a multimodal program that
integrates a program of therapeutic exercise, medication review, adequacy of diet and health
education, compared with standard medical practice in improving neuromuscular and
physiological status on frail elderly. Another aim is to analyze the maintenance of these
effects by monitoring long-term (12 months) from the start of the intervention.
Design: Randomized controlled trial Scope / Study subjects: recruited frail elderly in Basic
Health Zone of Malaga. Methods: The subjects to be included in the study (after meeting
inclusion / exclusion) will be randomized into two groups: a control group whose intervention
will be to review medication + adequacy of diet + health education (physical activity
recommendation (within a comprehensive advice on healthy lifestyles) and an experimental
group whose intervention will be a Multimodal Intervention: therapeutic exercise + review
medication + adequacy of diet + health education program.
Sociodemographic, Clinical and monitoring Variables will be collected at baseline. Moreover,
tracking variables will be collected at 2 and 6 months after starting the intervention and at
3 and 6 months after the end of the intervention (monitoring).
The monitoring variables that will be measured are: BMI , general health, fatigue,
brittleness, Motor Control, Attention - Concentration - Memory, Motor Memory , spatial
orientation, grip strength, balance (static - semi-static and dynamic ), gait speed and
metabolomic variables.
One descriptive analysis of the sociodemographic variables of the participants will be
performed. Further the change on the variables intra-subjects (pre-post intervention) and
inter-subjects (experimental group vs control group) will be calculated. For the
intra-subject analysis will be performed a ANOVA-one factor analysis. The intersubject
outcome variables will be compared between the two groups in each moments of data collection,
using the student t-test or Wilconxon (depending of the sample distribution). The level of
significance was set at P ≤ 0.05.
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