Effects of a Multicomponent Training in Pre-frail Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pre-frail Elderly

Intervention / Treatment
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* Other: Physical Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The training group will perform a Physical Exercise as multicomponent training. | Other: Physical Exercise<br>* 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.<br>* Other names: Multicomponent exercise training;|
| No Intervention: Control<br>The control group will only be evaluated, without any intervention. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Frailty, Multicomponent training, Physical exercise, Functional capacity, Complexity, Physical Therapy