Effectiveness of a Multi-component Physical Training in Hyper-fragile Elders: A Randomized Clinical Trial

Summary

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.

Conditions

• Multimodal Intervention
• Fragility
• Other Metabolic Diseases
• Physical Activity
• Patient Fall
• Dietary Modification

Interventions

OTHER

Control Intervention

Control Intervention: review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles)

OTHER

Multimodal Intervention

Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program

Sponsors & Collaborators

• Andaluz Health Service

  collaborator OTHER_GOV

• University of Malaga

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-11-01

Primary Completion

2024-06-01

Completion

2024-06-01

Countries

• Spain

Study Locations