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

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: Unknown
• Conditions: Exercise; Kidney Transplantation
• Intervention / Treatment: Other: Platform; Other: Platform sham

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tuira Maia; Phone Number: 55 81 21268496; Email: tuiraomaia@gmail.com
• Study Contact Backup: Name: Patrícia Marinho; Phone Number: 55 81 21268496; Email: patmarinho@yahoo.com.br

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil
      • Recruiting
      • Laboratório Cardiopulmonar
      • Contact: Tuira Maia; Phone Number: 55 81 21268496; Email: tuiraomaia@gmail.com
      • Contact: Lívia Rocha; Phone Number: 55 81 21268496; Email: liviagomesrocha@hotmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of the quadriceps	This measure will be obtained through the portable Ultrasound	10 minutes
Postural balance	The static and dynamic postural balance will be evaluated through the Biodex Balance System	20 minutes
Pulmonary function	Slow and forced spirometry will be used	15 minutes
Risk of fall	The International Fall Efficiency Scale (FES-I) will be used	5 minutes
Level of physical activity	It will be evaluated by the International Physical Activity Questionnaire	5 minutes
Quality of life	Will be applied the Medical Outcomes Study Quality of Life Questionnaire - Short-Form Health Survey	10 minutes

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Principal Investigator: Lívia Rocha, Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Anticipated): October 23, 2017
• Study Completion (Anticipated): December 15, 2017

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 14, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID 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