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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03120377
• Other study ID #: LRocha
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2017
• Last updated: April 14, 2017
• Start date: March 2, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: April 2017
• Source: Universidade Federal de Pernambuco
• Contact: Tuira Maia
• Phone: 55 81 21268496
• Email: tuiraomaia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 15, 2017
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise
• Kidney Transplantation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Laboratório Cardiopulmonar	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps muscle strength	Will be performed the examination of the Maximum Voluntary Isometric Contraction	20 minutes
Primary	Functional capacity	The 6-minute walk test will be used	10 minutes
Primary	Respiratory muscle strength	Will be performed through the manocacuometry with the evaluation of the maximum respiratory pressures	20 minutes
Secondary	Thickness of the quadriceps	This measure will be obtained through the portable Ultrasound	10 minutes
Secondary	Postural balance	The static and dynamic postural balance will be evaluated through the Biodex Balance System	20 minutes
Secondary	Pulmonary function	Slow and forced spirometry will be used	15 minutes
Secondary	Risk of fall	The International Fall Efficiency Scale (FES-I) will be used	5 minutes
Secondary	Level of physical activity	It will be evaluated by the International Physical Activity Questionnaire	5 minutes
Secondary	Quality of life	Will be applied the Medical Outcomes Study Quality of Life Questionnaire - Short-Form Health Survey	10 minutes