Effects of a Multicomponent Training in Pre-frail Elderly

NCT ID: NCT03110419

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-08-10

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.

Conditions

Pre-frail Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Physical Exercise

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Multicomponent exercise training

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Anielle C M Takahashi

PhD, Adjunt Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anielle CM Takahashi, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Sao Carlos

Locations

Federal University of São Carlos

São Carlos, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 39259383 (View on PubMed)

Other Identifiers

LAPESI-02

Identifier Type: -

Identifier Source: org_study_id