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

NCT ID: NCT02772952

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2024-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

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)

Group Type: OTHER

Control Intervention

Intervention Type: OTHER

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

Experimental Group

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

Group Type: EXPERIMENTAL

Multimodal Intervention

Intervention Type: OTHER

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

Interventions

Control Intervention

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

Intervention Type: OTHER

Multimodal Intervention

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Andaluz Health Service

OTHER_GOV

Sponsor Role: collaborator

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Dr. Antonio I Cuesta-Vargas

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Antonio Cuesta-Vargas

Málaga, , Spain

Countries

Spain

References

Gonzalez-Sanchez M, Cuesta-Vargas AI, Del Mar Rodriguez Gonzalez M, Caro ED, Nunez GO, Galan-Mercant A, Belmonte JJB. Effectiveness of a muticomponent workout program integrated in an evidence based multimodal program in hyperfrail elderly patients: POWERAGING randomized clinical trial protocol. BMC Geriatr. 2019 Jun 21;19(1):171. doi: 10.1186/s12877-019-1188-x.

Reference Type: DERIVED

PMID: 31226936 (View on PubMed)

Other Identifiers

Power-Aging-01

Identifier Type: -

Identifier Source: org_study_id