Immediate and Chronic Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly

Neuromuscular Performance and Balance Clinical Trial

Official title:

Immediate and Chronic Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253042
• Other study ID #: DL2017
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2019
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuromuscular Performance and Balance

Intervention

Other:
• WBV exercise program
The intervention will consist of a 8-week whole-body vibration exercise program with the platform configured at a frequency of 40 Hz and peak-to-peak amplitude of 4 mm. The sessions will be held 2 times a week, consisting of 4 sets of 1 and a half minutes of exercise on the platform. Rest intervals of 1 minute between sets will be respected.
• Sham WBV exercise program
The intervention will consist of a 8-week exercise program, but the platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation.

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Norte (UFRN)	Natal	RN

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Muscle Performance measured through isokinetic dynamometer	The muscle performance will be measured through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight, average power, total work and time to peak torque.	Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
Secondary	Change in Muscle activation measured through surface electromyography	Measured by surface electromyography	Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
Secondary	Change in Balance measured through baropodometry	Measured by baropodometry	Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
Secondary	Change in Quality of life measured through SF-36 questionnaire	measured by SF-36 questionnaire score	Baseline, after 4 and 8 weeks of the beginning of exercise program.
Secondary	Change in Functional mobility measured through Timed up and Go test	measured by Timed up and Go test time	Baseline, after 4 and 8 weeks of the beginning of exercise program.