Kidney TransplantationNCT03120377
Efficiency of a Whole Body Vibration Training Program in Adult Renal Transplanted Patients
A study testing Platform in people with Kidney Transplantation and Exercise, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Kidney Transplantation, Exercise
- What is being tested?
- Platform
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Mar 2017to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratório Cardiopulmonar
Recife, Pernambuco
Lívia Rocha, 55 81 21268496, liviagomesrocha@hotmail.com
Tuira Maia, 55 81 21268496, tuiraomaia@gmail.com
About this study
Official title: 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
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.
- Conditions
- Kidney Transplantation, Exercise
- Being tested
- Platform, Platform sham
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Platform group | Active comparator | Group submitted to the whole body vibration training program Receives: 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. Receives: Other: Platform sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle strength
Will be performed the examination of the Maximum Voluntary Isometric Contraction
Measured: 20 minutes
Functional capacity
The 6-minute walk test will be used
Measured: 10 minutes
Respiratory muscle strength
Will be performed through the manocacuometry with the evaluation of the maximum respiratory pressures
Measured: 20 minutes
Secondary outcomes (6)
Thickness of the quadriceps
This measure will be obtained through the portable Ultrasound
Measured: 10 minutes
Postural balance
The static and dynamic postural balance will be evaluated through the Biodex Balance System
Measured: 20 minutes
Pulmonary function
Slow and forced spirometry will be used
Measured: 15 minutes
Risk of fall
The International Fall Efficiency Scale (FES-I) will be used
Measured: 5 minutes
Level of physical activity
It will be evaluated by the International Physical Activity Questionnaire
Measured: 5 minutes
Quality of life
Will be applied the Medical Outcomes Study Quality of Life Questionnaire - Short-Form Health Survey
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start2 Mar 2017
- Primary completion23 Oct 2017 (estimated)
- Study completion15 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lívia Gomes da Rocha, Universidade Federal de Pernambuco
- Investigators
- Lívia Rocha, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120377
- Sponsor's protocol ID
- LRocha
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory and Musculoskeletal Effects After a Whole Body Vibration Training Program in Adult Renal Transplant Recipients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03120377
- Acronym / sponsor ID
- LRocha
- Conditions
- Kidney Transplantation, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 23 Oct 2017 (estimated)
- Study completion
- 15 Dec 2017 (estimated)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platform group | Active comparator | Other: PlatformGroup submitted to the whole body vibration training program |
| Platform sham group | Sham comparator | Other: Platform shamGroup 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlatformWhole 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. | Other | Platform group |
| Platform shamwill 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. | Other | Platform sham group |
Primary outcome
Quadriceps muscle strength
Time frame: 20 minutes
Will be performed the examination of the Maximum Voluntary Isometric Contraction
Functional capacity
Time frame: 10 minutes
The 6-minute walk test will be used
Respiratory muscle strength
Time frame: 20 minutes
Will be performed through the manocacuometry with the evaluation of the maximum respiratory pressures
6 secondary outcomes
Thickness of the quadriceps
Time frame: 10 minutes
Postural balance
Time frame: 20 minutes
Pulmonary function
Time frame: 15 minutes
Risk of fall
Time frame: 5 minutes
Level of physical activity
Time frame: 5 minutes
Quality of life
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lívia Rocha principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platform in people with Kidney Transplantation and Exercise, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuira Maia (55 81 21268496, tuiraomaia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps muscle strength (time frame: 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.