Effects of a Multicomponent Training in Pre-frail Elderly

Effects of a Multicomponent Training on Postural Control and Cardiovascular and Musculoskeletal Systems in Pre-frail Elderly

This study aim to evaluate the effects of 16 weeks of multicomponent training on postural control, cardiovascular and musculoskeletal systems in pre-frail elderly through nonlinear and linear measurements.

Study Overview

• Status: Completed
• Conditions: Pre-frail Elderly
• Intervention / Treatment: Other: Physical Exercise

Detailed Description

Frailty syndrome is described as a clinical state of vulnerability to stress resulting from the decline of resilience and physiological reserves associated with aging. It is also characterized by a reduction of the interaction between systems and that would be reflected by a loss of physiological complexity. Physical exercise, especially the multi-component, is pointed out as a key element in the intervention of frail elderly individuals. However, it is still unclear whether the improvement in functional capacity observed with this type of training would be related to changes in the physiological complexity of these elderly individuals. The aim of this study is to evaluate the effect of multi-component training on the dynamics of the cardiovascular, motor, neuromuscular and physical activity levels of pre-frail elderly. Thirty-six pre-frail elderly individuals will be divided into intervention (IG, n = 18) and control (CG, n = 18) groups at three different moments (pre-intervention, post-intervention, 16 weeks, and follow-up of detraining of 6 Weeks). The complexity will be evaluated by calculating the entropy of the biological signals: a) heart rate, blood pressure (in supine and orthostatic conditions), b) oscillations of the pressure center (in open, closed eyes, after standing in a chair And under dual-task cognitive condition), c) torque oscillations of the knee extensor muscle group.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Carlos, São Paulo, Brazil, 13565-905
      • Federal University of São Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >= 65 years old;
• conventional ECG without alterations in rest;
• medical release for physical exercise;
• understand the instructions and agree to participate.

Exclusion Criteria:

• historical stroke which produces loss of strength and aphasia;
• several impairment of motor skills;
• Parkinson disease;
• Diabetes Mellitus;
• Peripheral Neuropathy;
• Vestibular and visual disorders self-reported in anamnesis;
• Severe cognitive impairment;
• Cardiovascular disorders (atrial fibrillation, malignant ventricular arrhythmia; ventricular beats complexes ectopic, sinus tachycardia or supraventricular, second and third degree of atrioventricular block, use of pacemaker in the resting ECG);
• Unstable angina;
• Myocardial infarction;
• Elderly end stage.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; The training group will perform a Physical Exercise as multicomponent training.	Other: Physical Exercise; The intervention program will follow the recommendations of the American College of Sports Medicine (ACSM, 2009), including aerobic, muscle strength, flexibility and balance exercise. The duration of the intervention will be 16 weeks with sessions 60 min performed in three alternate days.; Other Names: Multicomponent exercise training
NO_INTERVENTION: Control; The control group will only be evaluated, without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear and nonlinear measurements of postural control	Sample Entropy; Approximate Entropy	Change from baseline sample entropy and approximate entropy at 16 weeks of multicomponent training and after 6 weeks of detraining
Linear and nonlinear measurements of cardiovascular system	Heart Rate Variability; Conditional Entropy	Change from baseline heart rate variability and conditional entropy at 16 weeks of multicomponent training and after 6 weeks of detraining
Linear and nonlinear measurements of musculoskeletal systems	Knee extensor torque complexity	Change from baseline knee extensor torque complexity at 16 weeks of multicomponent training and after 6 weeks of detraining
Cognition Measures	Addenbrooke's Cognitive Examination	Change from baseline addenbrooke's cognitive examination at 16 weeks of multicomponent training and after 6 weeks of detraining

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Measures	Six-minute Walk Test	Change from baseline six-minute walk test at 16 weeks of multicomponent training and after 6 weeks of detraining
Functional Measures	Short Physical Performance Battery	Change from baseline short physical performance battery at 16 weeks of multicomponent training and after 6 weeks of detraining

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Investigators: Principal Investigator: Anielle CM Takahashi, PhD, Universidade Federal de Sao Carlos

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): June 22, 2018
• Study Completion (ACTUAL): August 10, 2018

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Elderly; Physical Therapy; Physical exercise; Frailty; Functional capacity; Complexity; Multicomponent training
• Other Study ID Numbers: LAPESI-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No