Effects of a Multicomponent Training in Pre-frail Elderly

Pre-frail Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110419
• Other study ID #: LAPESI-02
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: August 10, 2018

Study information

• Verified date: April 2019
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 10, 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pre-frail Elderly

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of São Carlos	São Carlos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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