Effects of a Multicomponent Training in Pre-frail Elderly

Overview

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.

Full Title of Study: “Effects of a Multicomponent Training on Postural Control and Cardiovascular and Musculoskeletal Systems in Pre-frail Elderly”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 22, 2018

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Intervention
    • The training group will perform a Physical Exercise as multicomponent training.
  • No Intervention: Control
    • The control group will only be evaluated, without any intervention.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universidade Federal de Sao Carlos
  • Collaborator
    • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anielle C M Takahashi, PhD, Adjunt Professor – Universidade Federal de Sao Carlos
  • Overall Official(s)
    • Anielle CM Takahashi, PhD, Principal Investigator, Universidade Federal de Sao Carlos

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