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Completed

NCT Number: NCT03110419

Effects of a Multicomponent Training 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Carlos

São Carlos, São Paulo, 13565-905, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical exercise

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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