Effectiveness of a Multi-component Physical Training in Hyper-fragile Elders: A Randomized Clinical Trial (PowerA-01)

University of Malaga

Status: Completed

Conditions: Physical Activity; Patient Fall; Dietary Modification; Fragility; Multimodal Intervention; Other Metabolic Diseases

Treatments: Other: Control Intervention; Other: Multimodal Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02772952

Power-Aging-01

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 65 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• People 65 years older than after screening of fragility as the test battery Short Physical Performance Battery (SPPB), can perform the therapeutic exercise program

Exclusion criteria

• Presence in the medical history of neuromuscular , metabolic, hormonal and / or cardiovascular disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups

Control Group

Other group

Description:

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)

Treatment:

Other: Control Intervention

Experimental Group

Experimental group

Description:

Experimental group whose intervention will be a Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program.

Treatment:

Other: Multimodal Intervention