CClinicalTrials.gg
Status unknownNCT03120377Updated Apr 19, 2017

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

An interventional study of Platform and Platform sham in Kidney Transplantation and Exercise, sponsored by Universidade Federal de Pernambuco. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2017-04-19.

Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Kidney Transplantation
  • Exercise
03

In context

Lead sponsor

Universidade Federal de Pernambuco is the lead sponsor of 161 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Platform group

    Group submitted to the whole body vibration training program

    Other: Platform

  • 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

Interventions

  • OtherPlatform

    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.

  • OtherPlatform 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.

06

What researchers measure

Primary outcomes

  1. Quadriceps muscle strength

    Will be performed the examination of the Maximum Voluntary Isometric Contraction

    Time frame: 20 minutes

  2. Functional capacity

    The 6-minute walk test will be used

    Time frame: 10 minutes

  3. Respiratory muscle strength

    Will be performed through the manocacuometry with the evaluation of the maximum respiratory pressures

    Time frame: 20 minutes

Secondary outcomes

  1. Thickness of the quadriceps

    This measure will be obtained through the portable Ultrasound

    Time frame: 10 minutes

  2. Postural balance

    The static and dynamic postural balance will be evaluated through the Biodex Balance System

    Time frame: 20 minutes

  3. Pulmonary function

    Slow and forced spirometry will be used

    Time frame: 15 minutes

  4. Risk of fall

    The International Fall Efficiency Scale (FES-I) will be used

    Time frame: 5 minutes

  5. Level of physical activity

    It will be evaluated by the International Physical Activity Questionnaire

    Time frame: 5 minutes

  6. Quality of life

    Will be applied the Medical Outcomes Study Quality of Life Questionnaire - Short-Form Health Survey

    Time frame: 10 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03120377
Lead sponsor
Universidade Federal de Pernambuco
Responsible party
Lívia Gomes da Rocha (physiotherapist of the post-graduation program in physiotherapy of the Federal University of Pernambuco, principal investigator, Universidade Federal de Pernambuco) — Principal investigator
First posted
Apr 19, 2017
Start date
Mar 2, 2017
Primary completion
Oct 23, 2017 (estimated)
Completion
Dec 15, 2017 (estimated)
Last update
Apr 19, 2017

Study contacts

Tuira Maia
Contact
tuiraomaia@gmail.com
55 81 21268496
Patrícia Marinho
Contact
patmarinho@yahoo.com.br
55 81 21268496
Lívia Rocha
principal investigator · Universidade Federal de Pernambuco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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