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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02482597
Other study ID # BHS-1129
Secondary ID
Status Completed
Phase N/A
First received June 23, 2015
Last updated March 27, 2018
Start date June 2015
Est. completion date June 1, 2017

Study information

Verified date March 2018
Source New York Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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 PolarĀ® 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date June 1, 2017
Est. primary completion date May 4, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Athletic Individuals who exercise regularly

Exclusion Criteria:

- Any implantable devices

- currently taking any medication that would effect blood pressure

- pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Whole Body Periodic Acceleration
A bed that translates back and forth at different frequencies while the subject lies supine

Locations

Country Name City State
United States New York Institute of Technology Old Westbury New York

Sponsors (1)

Lead Sponsor Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

References & Publications (6)

Brown 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. — View Citation

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. — View Citation

Kohler 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. — View Citation

Sackner 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. — View Citation

Sackner MA, Gummels E, Adams JA. Nitric oxide is released into circulation with whole-body, periodic acceleration. Chest. 2005 Jan;127(1):30-9. — View Citation

Taoutaou 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Lactate We will use a finger stick to collect plasma post exercise 20 minutes post exercise
Secondary Oxygen Uptake Oxygen uptake is measured by a subject wearing a mask that measures what they exhale. 20 minutes post exercsie
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