Clinical trial NCT03110419: Effects of a Multicomponent Training in Pre-frail Elderly
Official title: Effects of a Multicomponent Training on Postural Control and Cardiovascular and Musculoskeletal Systems in Pre-frail Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-frail Elderly
Keywords: Elderly
Frailty
Multicomponent training
Physical exercise
Functional capacity
Complexity
Physical Therapy
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2017-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Linear and nonlinear measurements of postural control
timeFrame: Change from baseline sample entropy and approximate entropy at 16 weeks of multicomponent training and after 6 weeks of detraining
measure: Linear and nonlinear measurements of cardiovascular system
timeFrame: Change from baseline heart rate variability and conditional entropy at 16 weeks of multicomponent training and after 6 weeks of detraining
measure: Linear and nonlinear measurements of musculoskeletal systems
timeFrame: Change from baseline knee extensor torque complexity at 16 weeks of multicomponent training and after 6 weeks of detraining
measure: Cognition Measures
timeFrame: Change from baseline addenbrooke's cognitive examination at 16 weeks of multicomponent training and after 6 weeks of detraining
Secondary outcomes:
measure: Functional Measures
timeFrame: Change from baseline six-minute walk test at 16 weeks of multicomponent training and after 6 weeks of detraining
measure: Functional Measures
timeFrame: Change from baseline short physical performance battery at 16 weeks of multicomponent training and after 6 weeks of detraining
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University of São Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Anielle CM Takahashi, PhD
role: PRINCIPAL_INVESTIGATOR
References: