Acidosis, LacticNCT02482597
Whole Body Periodic Acceleration on Blood Lactate and Recovery
A study testing Whole Body Periodic Acceleration in people with Acidosis, Lactic, run by New York Institute of Technology at 1 site in United States.
Trial summary
Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease 6. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Acidosis, Lactic
- What is being tested?
- Whole Body Periodic Acceleration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 1 Jun 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Athletic Individuals who exercise regularly
Who cannot join
- Any implantable devices
- currently taking any medication that would effect blood pressure
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology
Old Westbury, New York, 11758
About this study
Official title: The Effects of Whole Body Periodic Acceleration on Blood Lactate and Recovery in Trained Individuals
Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease 6. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation (up to 180 cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by the patient or health care professional.
The science behind the therapeutic effects of WBPA still remains largely unknown.
The objective of this study is to determine if WBPA may be used as an effective way to reduce lactic acid concentrations during recovery after intense exercise more rapidly than previously established methods.
Read the detailed description
Each visit Subjects will perform a graded treadmill exercise test. They will rest for 10 minutes. At the end of the rest period, resting vital signs (HR and BP) will be recorded as well as resting oxygen consumption (VO2). Resting capillary blood sample will be taken and analyzed by the Accutrend portable lactate analyzer to measure blood lactate levels. The cardiac and metabolic recordings will be measured by PFT GX machine (Medgraphics Ultima; St. Paul, Minnesota) that will record VO2, VCO2, RER (respiratory exchange ratio), Ve. Heart Rate will be monitored by a Polar® HR monitor. This machine is attached to a motorized treadmill with handrails. Each subject will perform a Modified Bruce Protocol which consists of a maximum of five 3-minute stages. The criteria set for peak exercise is one of the following: 1) 90% of THR; 2) a plateau of oxygen uptake is indicated; 3) if the subject is unable to maintain the pace of the treadmill; 4) an RER of over 1.0 and/or 5) a plateau in Ve (3). Additionally, the American College of Sports Medicine (ACSM) guidelines for terminating exercise testing will be followed(American College of Sports Medicine).
TIMELINE of PROCEDURES
The following recoveries will be tested on 3 separate days:
Visit 1 The subject will walk at 30-40 % of V02 max for the next 20 minutes on the treadmill after peak exercise. Blood lactate will be taken at minute 20.
Visit 2 The subject will be taken off the treadmill after a 3 minute walk and placed on the WBPA bed. The horizontal displacement will be held constant at 14 mm, and cycles/min will be held constant at 140. There is a footboard where the subjects feet are strapped in while wearing their own shoes. The platform moves in a repetitive motion from head-to- foot imparting mild periodic inertial forces in the subject's spinal axis (pGz). Blood lactate will be taken at minute 20.
Visit 3
The subject will be taken off the treadmill after a 3 minute walk and asked to sit in a chair for 20 minutes. Blood lactate will be taken at minute 20.
- Conditions
- Acidosis, Lactic
- Being tested
- Whole Body Periodic Acceleration
- Medical subject headings
- Acidosis, Lactic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body Periodic AccelerationDevice
A bed that translates back and forth at different frequencies while the subject lies supine
| Study group | Role | What they receive |
|---|---|---|
| WBPA (Whole Body Accleration) | Experimental | Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease 6. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation (up to 180 cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by the patient or health care professional. Receives: Device: Whole Body Periodic Acceleration |
| Active Recovery | Active comparator | Active recovery methods (e.g.walking, biking) have been shown to decrease blood lactate levels more than passive recovery 1,2. This arm requires subjects to walk at a low intensity as recovery. Receives: Device: Whole Body Periodic Acceleration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Lactate
We will use a finger stick to collect plasma post exercise
Measured: 20 minutes post exercise
Secondary outcomes (1)
Oxygen Uptake
Oxygen uptake is measured by a subject wearing a mask that measures what they exhale.
Measured: 20 minutes post exercsie
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion4 May 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acidosis, LacticStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne DiFrancisco-Donoghue, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482597
- Sponsor's protocol ID
- BHS-1129
- Status last verified
- Mar 2018
- First submitted
- 23 Jun 2015
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Gmada N, Bouhlel E, Mrizak I, Debabi H, Ben Jabrallah M, Tabka Z, Feki Y, Amri M. Effect of combined active recovery from supramaximal exercise on blood lactate disappearance in trained and untrained man. Int J Sports Med. 2005 Dec;26(10):874-9. doi: 10.1055/s-2005-837464.
PubMed 16320173Taoutaou Z, Granier P, Mercier B, Mercier J, Ahmaidi S, Prefaut C. Lactate kinetics during passive and partially active recovery in endurance and sprint athletes. Eur J Appl Physiol Occup Physiol. 1996;73(5):465-70. doi: 10.1007/BF00334425.
PubMed 8803508Brown J, Glaister M. The interactive effects of recovery mode and duration on subsequent repeated sprint performance. J Strength Cond Res. 2014 Mar;28(3):651-60. doi: 10.1519/JSC.0b013e3182a1fe28.
PubMed 23820561Sackner MA, Gummels E, Adams JA. Effect of moderate-intensity exercise, whole-body periodic acceleration, and passive cycling on nitric oxide release into circulation. Chest. 2005 Oct;128(4):2794-803. doi: 10.1378/chest.128.4.2794.
PubMed 16236957Sackner MA, Gummels E, Adams JA. Nitric oxide is released into circulation with whole-body, periodic acceleration. Chest. 2005 Jan;127(1):30-9. doi: 10.1378/chest.127.1.30.
PubMed 15653959Kohler M, Amann-Vesti BR, Clarenbach CF, Brack T, Noll G, Russi EW, Bloch KE. Periodic whole body acceleration: a novel therapy for cardiovascular disease. Vasa. 2007 Nov;36(4):261-6. doi: 10.1024/0301-1526.36.4.261.
PubMed 18357918
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whole Body Periodic Acceleration on Blood Lactate and Recovery in Trained Individuals
- ClinicalTrials.gov ID
- NCT02482597
- Acronym / sponsor ID
- BHS-1129
- Conditions
- Acidosis, Lactic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 26 Jun 2015 (estimated)
- 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.
Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease 6. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation (up to 180 cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by the patient or health care professional.
The science behind the therapeutic effects of WBPA still remains largely unknown.
The objective of this study is to determine if WBPA may be used as an effective way to reduce lactic acid concentrations during recovery after intense exercise more rapidly than previously established methods.
Detailed description
Each visit Subjects will perform a graded treadmill exercise test. They will rest for 10 minutes. At the end of the rest period, resting vital signs (HR and BP) will be recorded as well as resting oxygen consumption (VO2). Resting capillary blood sample will be taken and analyzed by the Accutrend portable lactate analyzer to measure blood lactate levels. The cardiac and metabolic recordings will be measured by PFT GX machine (Medgraphics Ultima; St. Paul, Minnesota) that will record VO2, VCO2, RER (respiratory exchange ratio), Ve. Heart Rate will be monitored by a Polar® HR monitor. This machine is attached to a motorized treadmill with handrails. Each subject will perform a Modified Bruce Protocol which consists of a maximum of five 3-minute stages. The criteria set for peak exercise is one of the following: 1) 90% of THR; 2) a plateau of oxygen uptake is indicated; 3) if the subject is unable to maintain the pace of the treadmill; 4) an RER of over 1.0 and/or 5) a plateau in Ve (3). Additionally, the American College of Sports Medicine (ACSM) guidelines for terminating exercise testing will be followed(American College of Sports Medicine).
TIMELINE of PROCEDURES
The following recoveries will be tested on 3 separate days:
Visit 1 The subject will walk at 30-40 % of V02 max for the next 20 minutes on the treadmill after peak exercise. Blood lactate will be taken at minute 20.
Visit 2 The subject will be taken off the treadmill after a 3 minute walk and placed on the WBPA bed. The horizontal displacement will be held constant at 14 mm, and cycles/min will be held constant at 140. There is a footboard where the subjects feet are strapped in while wearing their own shoes. The platform moves in a repetitive motion from head-to- foot imparting mild periodic inertial forces in the subject's spinal axis (pGz). Blood lactate will be taken at minute 20.
Visit 3
The subject will be taken off the treadmill after a 3 minute walk and asked to sit in a chair for 20 minutes. Blood lactate will be taken at minute 20.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WBPA (Whole Body Accleration) | Experimental | Device: Whole Body Periodic AccelerationWhole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease 6. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation (up to 180 cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by the patient or health care professional. |
| Active Recovery | Active comparator | Device: Whole Body Periodic AccelerationActive recovery methods (e.g.walking, biking) have been shown to decrease blood lactate levels more than passive recovery 1,2. This arm requires subjects to walk at a low intensity as recovery. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Athletic Individuals who exercise regularly
Key exclusion criteria (3 listed)
- Any implantable devices
- currently taking any medication that would effect blood pressure
- pregnancy
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 Periodic AccelerationA bed that translates back and forth at different frequencies while the subject lies supine | Device | Active Recovery, WBPA (Whole Body Accleration) |
Primary outcome
Blood Lactate
Time frame: 20 minutes post exercise
We will use a finger stick to collect plasma post exercise
1 secondary outcome
Oxygen Uptake
Time frame: 20 minutes post exercsie
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 16320173Gmada N, Bouhlel E, Mrizak I, Debabi H, Ben Jabrallah M, Tabka Z, Feki Y, Amri M. Effect of combined active recovery from supramaximal exercise on blood lactate disappearance in trained and untrained man. Int J Sports Med. 2005 Dec;26(10):874-9. doi: 10.1055/s-2005-837464.
- Background: PubMed 8803508Taoutaou Z, Granier P, Mercier B, Mercier J, Ahmaidi S, Prefaut C. Lactate kinetics during passive and partially active recovery in endurance and sprint athletes. Eur J Appl Physiol Occup Physiol. 1996;73(5):465-70. doi: 10.1007/BF00334425.
- Background: PubMed 23820561Brown J, Glaister M. The interactive effects of recovery mode and duration on subsequent repeated sprint performance. J Strength Cond Res. 2014 Mar;28(3):651-60. doi: 10.1519/JSC.0b013e3182a1fe28.
- Background: PubMed 16236957Sackner MA, Gummels E, Adams JA. Effect of moderate-intensity exercise, whole-body periodic acceleration, and passive cycling on nitric oxide release into circulation. Chest. 2005 Oct;128(4):2794-803. doi: 10.1378/chest.128.4.2794.
- Background: PubMed 15653959Sackner MA, Gummels E, Adams JA. Nitric oxide is released into circulation with whole-body, periodic acceleration. Chest. 2005 Jan;127(1):30-9. doi: 10.1378/chest.127.1.30.
- Background: PubMed 18357918Kohler M, Amann-Vesti BR, Clarenbach CF, Brack T, Noll G, Russi EW, Bloch KE. Periodic whole body acceleration: a novel therapy for cardiovascular disease. Vasa. 2007 Nov;36(4):261-6. doi: 10.1024/0301-1526.36.4.261.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodic Acceleration in people with Acidosis, Lactic, run by New York Institute of Technology at 1 site in United States.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 29 Mar 2018. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Lactate (time frame: 20 minutes post exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02482597, which also lists 6 linked publications.
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 29 Mar 2018.