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

NCT ID: NCT03120377

Last Updated: 2017-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-02

Study Completion Date

2017-12-15

Brief Summary

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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

Detailed Description

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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.

Conditions

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Kidney Transplantation Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Platform group

Group submitted to the whole body vibration training program

Group Type ACTIVE_COMPARATOR

Platform

Intervention Type OTHER

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.

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.

Group Type SHAM_COMPARATOR

Platform sham

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Lívia Gomes da Rocha

physiotherapist of the post-graduation program in physiotherapy of the Federal University of Pernambuco, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lívia Rocha

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Pernambuco

Locations

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Laboratório Cardiopulmonar

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Tuira Maia

Role: CONTACT

55 81 21268496

Patrícia Marinho

Role: CONTACT

55 81 21268496

Facility Contacts

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Lívia Rocha

Role: primary

55 81 21268496

Tuira Maia

Role: backup

55 81 21268496

Other Identifiers

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LRocha

Identifier Type: -

Identifier Source: org_study_id

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