NCT03120377

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

April 10, 2017

Last Update Submit

April 14, 2017

Conditions

Kidney TransplantationExercise

Outcome Measures

Primary Outcomes (3)

  • Quadriceps muscle strength

    Will be performed the examination of the Maximum Voluntary Isometric Contraction

    20 minutes

  • Functional capacity

    The 6-minute walk test will be used

    10 minutes

  • Respiratory muscle strength

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

    20 minutes

Secondary Outcomes (6)

  • Thickness of the quadriceps

    10 minutes

  • Postural balance

    20 minutes

  • Pulmonary function

    15 minutes

  • Risk of fall

    5 minutes

  • Level of physical activity

    5 minutes

  • +1 more secondary outcomes

Study Arms (2)

Platform group

ACTIVE COMPARATOR

Group submitted to the whole body vibration training program

Other: Platform

Platform sham group

SHAM COMPARATOR

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

PlatformOTHER

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 group
Platform shamOTHER

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.

Platform sham group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratório Cardiopulmonar

Recife, Pernambuco, Brazil

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lívia Rocha

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuira Maia

CONTACT

55 81 21268496tuiraomaia@gmail.com

Patrícia Marinho

CONTACT

55 81 21268496patmarinho@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist of the post-graduation program in physiotherapy of the Federal University of Pernambuco, principal investigator

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 19, 2017

Study Start

March 2, 2017

Primary Completion

October 23, 2017

Study Completion

December 15, 2017

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

BR(1)