Renal Transplant RecipientsNCT03110406
Effects of Whole-body Vibration Training on the Heart Rate Variability Cardiac in Kidney Transplantation
A study testing whole-body vibration training in people with Renal Transplant Recipients, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Introduction: Renal transplantation represents the therapeutic mode with more durable treatment, greater cost-effectiveness, survival benefits and quality of life of the patients, however, with high cardiovascular mortality. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Renal Transplant Recipients
- What is being tested?
- whole-body vibration training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2017to 10 Mar 2018
- 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
- Age between 18 and 59 years
- who underwent transplantation at least one year before
- present a stable transplantation function through the creatinine level <1.8 mg / dL
- No drug use with ability to modify the autonomic nervous system, such as sympatholytic drugs
Who cannot join
- unstable hypertension;
- Amyloidosis;
- Congestive heart failure, recent myocardial infarction, unstable angina;
- Musculoskeletal abnormality that impairs the performance of the exercises;
- Have a metal implant or cardiac pacemaker.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Pernambuco
Recife, Pernambuco, 50740-050
Tuíra O Maia, 81997160176
About this study
Official title: Effects of Whole-body Vibration Training on the Heart Rate Variability Cardiac in Kidney Transplantation: a Randomized Controlled Trial
Introduction: Renal transplantation represents the therapeutic mode with more durable treatment, greater cost-effectiveness, survival benefits and quality of life of the patients, however, with high cardiovascular mortality.
Objectives: To evaluate the acute and chronic effects on heart rate variability and the impact of chronic kidney disease on cardiorespiratory fitness in renal transplant recipients following a full-body Vibration training program.
Methods: It will be a blinded randomized clinical trial (patient, evaluator and statistician), controlled and endowed with secrecy of allocation, to be performed in the Cardiopulmonary Physiotherapy Laboratory of the Physiotherapy Department of the Federal University of Pernambuco. Renal transplant recipients will be recruited at the Nephrology outpatient clinic of the Hospital das Clínicas de Pernambuco, according to the following inclusion criteria: age between 18 and 59 years, who underwent transplantation at least one year before and present a stable transplant function through the level Of creatinine
Read the detailed description
It will be a blinded randomized clinical trial (patient, evaluator and statistician), controlled and endowed with secrecy of allocation, to be performed in the Cardiopulmonary Physiotherapy Laboratory of the Physiotherapy Department of the Federal University of Pernambuco. Renal transplant recipients will be recruited at the Nephrology outpatient clinic of the Hospital das Clínicas de Pernambuco, according to the inclusion criteria
- Conditions
- Renal Transplant Recipients
- Being tested
- whole-body vibration training
- Keywords
- renal transplant recipients, exercise, heart rate variability, Cardiovascular mortality
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-body vibration trainingOther
Training on the Vibrating platform will be performed with the patients in the static position.The exercises will be performed in the first two weeks for 10 minutes consisting of 60 seconds of low intensity and 30 seconds of standing rest in the anatomical position. From the second week to the end of the twelfth week (24 sessions) will be performed 15 minutes corresponding being 60 seconds of high intensity interspersed with 30 seconds of rest standing in the anatomical position. In the second month, the patient should be well adapted to the stimuli of the platform keeping the frequency of 35Hz and the amplitude 4mm. Monitoring of blood pressure, heart rate and peripheral oxygen saturation should be done every 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| whole-body vibration | Experimental | The whole-body vibration training will be performed with the patients in the static position, feet apart at 20 cm, semi-squat with knees at 15º flexion and upper limbs slightly flexed and supported on the platform. The exercises will be performed, in the first two weeks, for 10 minutes consisting of 60 seconds of low intensity with 30 seconds of rest standing in the anatomical position. From the second week to the end of the twelfth week (24 sessions) will be performed 15 minutes corresponding being 60 seconds of high intensity interspersed with 30 seconds of rest standing in the anatomical position. In the second month, the patient should be well adapted to the stimuli of the platform keeping the frequency of 35Hz and the amplitude 4mm. ° Receives: Other: whole-body vibration training |
| Simulated whole-body vibration | Sham comparator | The simulated whole-body vibration training will be performed with the patients in the static position, feet apart at 20 cm, in semi-squat with knees at 15º of flexion and upper limbs slightly flexed and supported on the platform that presents a motor that simulates the noise of the platform But does not produce any therapeutic effect Receives: Other: whole-body vibration training |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability
Heart rate variability will be assessed through holter
Measured: three months
Secondary outcomes (1)
Oxygen consumption
Oxygen consumption will be assessed through exercise test
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start10 Mar 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion10 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant RecipientsStudies 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
- Model description
- Intervention group and control group
- Masking
- Triple blind
- Who is masked
- Participant, 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, TUIRA OLIVEIRA MAIA, Universidade Federal de Pernambuco
- Investigators
- TUIRA O M, Principal investigator, UFPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110406
- Sponsor's protocol ID
- TUIRAMAIA
- Status last verified
- Mar 2017
- First submitted
- 22 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-body Vibration Training on the Heart Rate Variability Cardiac in Kidney Transplantation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03110406
- Acronym / sponsor ID
- TUIRAMAIA
- Conditions
- Renal Transplant Recipients
- Keywords
- renal transplant recipients, exercise, heart rate variability, Cardiovascular mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 10 Mar 2018 (estimated)
- First posted
- 12 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.
Introduction: Renal transplantation represents the therapeutic mode with more durable treatment, greater cost-effectiveness, survival benefits and quality of life of the patients, however, with high cardiovascular mortality.
Objectives: To evaluate the acute and chronic effects on heart rate variability and the impact of chronic kidney disease on cardiorespiratory fitness in renal transplant recipients following a full-body Vibration training program.
Methods: It will be a blinded randomized clinical trial (patient, evaluator and statistician), controlled and endowed with secrecy of allocation, to be performed in the Cardiopulmonary Physiotherapy Laboratory of the Physiotherapy Department of the Federal University of Pernambuco. Renal transplant recipients will be recruited at the Nephrology outpatient clinic of the Hospital das Clínicas de Pernambuco, according to the following inclusion criteria: age between 18 and 59 years, who underwent transplantation at least one year before and present a stable transplant function through the level Of creatinine
Detailed description
It will be a blinded randomized clinical trial (patient, evaluator and statistician), controlled and endowed with secrecy of allocation, to be performed in the Cardiopulmonary Physiotherapy Laboratory of the Physiotherapy Department of the Federal University of Pernambuco. Renal transplant recipients will be recruited at the Nephrology outpatient clinic of the Hospital das Clínicas de Pernambuco, according to the inclusion criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| whole-body vibration | Experimental | Other: whole-body vibration trainingThe whole-body vibration training will be performed with the patients in the static position, feet apart at 20 cm, semi-squat with knees at 15º flexion and upper limbs slightly flexed and supported on the platform. The exercises will be performed, in the first two weeks, for 10 minutes consisting of 60 seconds of low intensity with 30 seconds of rest standing in the anatomical position. From the second week to the end of the twelfth week (24 sessions) will be performed 15 minutes corresponding being 60 seconds of high intensity interspersed with 30 seconds of rest standing in the anatomical position. In the second month, the patient should be well adapted to the stimuli of the platform keeping the frequency of 35Hz and the amplitude 4mm. ° |
| Simulated whole-body vibration | Sham comparator | Other: whole-body vibration trainingThe simulated whole-body vibration training will be performed with the patients in the static position, feet apart at 20 cm, in semi-squat with knees at 15º of flexion and upper limbs slightly flexed and supported on the platform that presents a motor that simulates the noise of the platform But does not produce any therapeutic effect |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 59 years
- who underwent transplantation at least one year before
- present a stable transplantation function through the creatinine level <1.8 mg / dL
- No drug use with ability to modify the autonomic nervous system, such as sympatholytic drugs
Key exclusion criteria (5 listed)
- unstable hypertension;
- Amyloidosis;
- Congestive heart failure, recent myocardial infarction, unstable angina;
- Musculoskeletal abnormality that impairs the performance of the exercises;
- Have a metal implant or cardiac pacemaker.
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 |
|---|---|---|
| whole-body vibration trainingTraining on the Vibrating platform will be performed with the patients in the static position.The exercises will be performed in the first two weeks for 10 minutes consisting of 60 seconds of low intensity and 30 seconds of standing rest in the anatomical position. From the second week to the end of the twelfth week (24 sessions) will be performed 15 minutes corresponding being 60 seconds of high intensity interspersed with 30 seconds of rest standing in the anatomical position. In the second month, the patient should be well adapted to the stimuli of the platform keeping the frequency of 35Hz and the amplitude 4mm. Monitoring of blood pressure, heart rate and peripheral oxygen saturation should be done every 5 minutes. | Other | Simulated whole-body vibration, whole-body vibration |
Primary outcome
heart rate variability
Time frame: three months
Heart rate variability will be assessed through holter
1 secondary outcome
Oxygen consumption
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: No
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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.
TUIRA O M principal investigator
UFPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole-body vibration training in people with Renal Transplant Recipients, 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 4 inclusion and 5 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 13 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 O MAIA (81997160176, tuiraomaia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability (time frame: three months). 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 13 Apr 2017.