Efficiency of a Whole Body Vibration Training Program in Adult Renal Transplanted Patients

April 14, 2017 updated by: Lívia Gomes da Rocha, Universidade Federal de Pernambuco

Respiratory and Musculoskeletal Effects After a Whole Body Vibration Training Program in Adult Renal Transplant Recipients: A Randomized Controlled Trial

Evaluate the effectiveness of a Whole body vibration training program on quadriceps muscle strength, functional capacity and respiratory muscle strength in adult renal transplant recipients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be a randomized controlled clinical trial involving adult renal transplant recipients, who will be recruited through eligibility criteria at Nephrology outpatient clinics of the Kidney Transplantation Centers of the Hospital das Clínicas of the Federal University of Pernambuco (HC-UFPE). Individuals will be randomized and assigned to one of the following groups: Platform Group, which will perform 12-week whole body vibration training or Platform SHAM Group that will receive treatment without the therapeutic effect of the platform. Afterwards, the patients will be submitted to an evaluation, a form with sociodemographic data, the clinical history of the disease and the laboratory tests will be completed, after which the pulmonary function, respiratory muscle strength, quadriceps muscle strength and thickness, postural balance , Functional capacity, quality of life, risk of falls and level of physical activity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with more than 1 year of kidney transplant surgery
  • stable graft function (creatinine <1.8 mg / dL)
  • hemoglobin> 8g / dL
  • age range 18 And 59
  • both sexes

Exclusion Criteria:

  • PAS> 160mmHg and PAD> 100mmHg
  • Patients with neurological, diagnosed or pulmonary heart disease
  • Involved in some physiotherapeutic program
  • With hospitalization history for 3 months
  • Pregnant
  • Current or previous smokers
  • That use pacemaker, screws and / or pins in the body
  • Presence of acute migraines, labyrinthitis
  • History of thrombosis
  • Body weight greater than 120Kg
  • Cognitive, visual and / or auditory deficits
  • Osteomioarticular diseases that would impair evaluation procedures and / or training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Platform group
Group submitted to the whole body vibration training program
Other: Platform
Whole body vibration training will consist of 12 consecutive weeks with two sessions per week on alternate days. Initially, before training with the vibratory platform, stretches lasting 5 to 10 minutes will be performed, with a series of 60 seconds for each of the following muscle groups: pectorals, sternocleidomastoids, scalenes, quadriceps and ischiatibial muscles. Patients will be monitored through vital signs for follow-up.
Sham Comparator: Platform sham group
Group that will receive the whole body vibration simulation treatment without the therapeutic effect of the platform, but with vibrating platform connected with the display on and a sound device coupled with vibration-generated noise recording, but without therapeutic purposes.
Other: Platform sham
will receive the treatment without the therapeutic effect of the platform, but with vibrating platform connected with the display lit and a sound device coupled with a noise recording generated by the vibration, but without therapeutic purposes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quadriceps muscle strength
Time Frame: 20 minutes
Will be performed the examination of the Maximum Voluntary Isometric Contraction
20 minutes
Functional capacity
Time Frame: 10 minutes
The 6-minute walk test will be used
10 minutes
Respiratory muscle strength
Time Frame: 20 minutes
Will be performed through the manocacuometry with the evaluation of the maximum respiratory pressures
20 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Thickness of the quadriceps
Time Frame: 10 minutes
This measure will be obtained through the portable Ultrasound
10 minutes
Postural balance
Time Frame: 20 minutes
The static and dynamic postural balance will be evaluated through the Biodex Balance System
20 minutes
Pulmonary function
Time Frame: 15 minutes
Slow and forced spirometry will be used
15 minutes
Risk of fall
Time Frame: 5 minutes
The International Fall Efficiency Scale (FES-I) will be used
5 minutes
Level of physical activity
Time Frame: 5 minutes
It will be evaluated by the International Physical Activity Questionnaire
5 minutes
Quality of life
Time Frame: 10 minutes
Will be applied the Medical Outcomes Study Quality of Life Questionnaire - Short-Form Health Survey
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Pernambuco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lívia Rocha, Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LRocha

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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