Clinical trial NCT03253042: Immediate and Chronic Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly
Official title: Immediate and Chronic Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Performance and Balance
Keywords: Exercise
Vibration
Torque
Aging
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the immediate and chronic effects of an exercise protocol on the vibration platform on the functional and neuromuscular performance of lower limbs, postural control and life quality in healthy elderly.

Detailed description: The research is a randomized controlled trial that will be developed at the Laboratório de Análise da Performance Muscular (LAPERN) of the Physiotherapy Department of the Federal University of Rio Grande do Norte (UFRN). The population of the present study will be formed by elderly individuals living in the city of Natal / RN, aged between 65 and 75 years, of both sexes, without distinction of race, education and marital status. The research sample will be of a non-probabilistic type, in which these will be allocated randomly into two distinct groups: placebo group (GP) and experimental group (GE). This research was submitted to the Research Ethics Committee (CEP) for UFRN through the national interface Plataforma Brasil. The present research contemplates the ethical aspects based on Resolution 466/2012 of the National Health Council (CNS) and the Declaration of Helsinki for research with humans. In addition, the survey will be recorded in Clinicals Trial. All data will be recorded in a database of the laboratory under confidentiality and can only be handled by the responsible researchers. The study will only begin after the issuance of the referent opinion approving the project. All subjects will be duly informed and instructed regarding the scheduled procedures, which will only be executed after reading, accepting and signing the Term of Free and Informed Consent (TFIC). After approval by the Research Ethics Committee, following resolution 466/2012, a pilot study was carried out aiming at the adequacy of all the research procedures, as well as the training of the researchers involved. Initially the research will begin with the selection of the sample according to the inclusion criteria descried elsewhere. The evaluation will be scheduled by telephone contact. Following this, the volunteers will receive the TFIC for reading and due signature. The data collection process will take place in four stages: (1) initial evaluation, (2) sample allocation (3) application of exercise program and (4) reevaluations. The evaluations will be composed by the dynamometric analysis associated with EMG (electromyography), functional performance and postural control analysis. The volunteers will be allocated randomly into 2 groups: placebo group (with the platform off) or experimental group (with the platform set at a frequency of 40 Hz and amplitude of 4 mm). Both will participate in a program of exercises in the platform, consisting of a static bipodal squat at 40 ° of knee flexion, with 4 sets of 1.5 min, with a rest interval of 1 minute. Immediately after the first session, 4 and 8 weeks of training, the volunteers will be submitted to the new evaluations, with the same procedures of the initial evaluation.

Eligibility criteria: Inclusion Criteria:

* Both genders;
* Exhibiting ankle, hip and knee joint integrity of the non-dominant limb;
* No history of muscle or joint injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments;
* Do not have metallic implants in the lower limbs;
* Do not have decompensated and / or untreated cardiovascular diseases;
* Do not have advanced osteoporosis;
* Do not have neurodegenerative diseases;
* Do not have vestibular disorders;
* Do not have uncorrected visual or hearing deficits.

Exclusion Criteria:

* Elderly classified as very active or active;
* Report cardiac and / or respiratory discomfort, nausea, vertigo and pain during during the evaluations and exercise sessions;
* Do not understand and do not correctly perform the commands offered in the assessment and / or intervention protocols;
* Miss 2 consecutive sessions during the exercise program.

Primary outcomes:
measure: Change in Muscle Performance measured through isokinetic dynamometer
timeFrame: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
Secondary outcomes:
measure: Change in Muscle activation measured through surface electromyography
timeFrame: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
measure: Change in Balance measured through baropodometry
timeFrame: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
measure: Change in Quality of life measured through SF-36 questionnaire
timeFrame: Baseline, after 4 and 8 weeks of the beginning of exercise program.
measure: Change in Functional mobility measured through Timed up and Go test
timeFrame: Baseline, after 4 and 8 weeks of the beginning of exercise program.
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Federal University of Rio Grande do Norte (UFRN)
state: RN
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Daniel T Borges, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio Grande do Norte
name: Lidiane C Correia, Esp
role: PRINCIPAL_INVESTIGATOR
References: