Effects of a Multicomponent Training in Pre-frail Elderly

NCT03110419 | Completed

• 1 other identifier: LAPESI-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-frail Elderly

Keywords

Elderly; Frailty; Multicomponent training; Physical exercise; Functional capacity; Complexity; Physical Therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Functional Measures

  Change from baseline six-minute walk test at 16 weeks of multicomponent training and after 6 weeks of detraining

• Functional Measures

  Change from baseline short physical performance battery at 16 weeks of multicomponent training and after 6 weeks of detraining

Study Arms (2)

Intervention

EXPERIMENTAL

The training group will perform a Physical Exercise as multicomponent training.

Other: Physical Exercise

Control

NO INTERVENTION

The control group will only be evaluated, without any intervention.

Interventions

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.

Also known as: Multicomponent exercise training

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• \>= 65 years old;
• conventional ECG without alterations in rest;
• medical release for physical exercise;
• understand the instructions and agree to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Federal University of São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

Related Publications (1)

• Carnavale BF, da Silva Santos VR, Farche ACS, Rossi PG, Fiogbe E, de Souza Buto MS, de Vassimon-Barroso V, de Medeiros Takahashi AC. Effects of a multicomponent training and detraining on frailty status, physical activity level, sedentary behavior patterns and physical performance of pre-frail older adults: a randomized controlled trial. Eur Geriatr Med. 2024 Dec;15(6):1701-1712. doi: 10.1007/s41999-024-01052-4. Epub 2024 Sep 11.

  PMID: 39259383 DERIVED

MeSH Terms

Conditions

Frailty; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anielle CM Takahashi, PhD

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Adjunt Professor

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: April 12, 2017
• Study Start: May 1, 2017
• Primary Completion: June 22, 2018
• Study Completion: August 10, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)