Studies
LIST OF STUDIES
The BRRC is a part of the North Florida/South Georgia Veterans Health System and is located at the Malcom Randall VA Medical Center in Gainesville, Florida.
Preclinical research is conducted in BRRC laboratories at the Malcom Randall VAMC and at its university affiliate, the University of Florida.
Clinical studies with participants – both Veterans and non-Veterans – are conducted at the Gainesville VAMC and at the following additional locations:
- Gainesville, Florida
- Jacksonville, Florida
"The U.S. Department of Veterans Affairs (VA) Brain Rehabilitation Research Center (BRRC) is conducting clinical research evaluating the Orygen Dual Valve, a portable respiratory strength training (RST) device Protocol for a Randomized Controlled Trial - PMC. [1, 2, 3]
Here are the details of the BRRC study and the device:
The Research
- The Study: The BRRC is running a randomized controlled trial (ClinicalTrials.gov identifier NCT04618754) led by principal investigator Dr. Dorian K. Rose. The study compares respiratory strength training with devices like the Orygen Dual Valve against an active respiratory relaxation training protocol Protocol for a Randomized Controlled Trial - PMC.
Dorian K. Rose 1, 2, 3, ✉ , Gina Brunetti 2 , Kathryn Cavka 2 , J. Brooke Hoisington 2 , Hannah Snyder 2 , Wei Xue 4 , Barbara K. Smith 1
Editors: Tiffany Leung , Dahlia Khajeei
PMCID: PMC11635318 PMID: 39602207
"Respiratory Training"
Participants will be randomized to the RST or RRT group.
RST Group
RST will consist of a bout of inspiratory strength training at the start of each EP session, plus a bout of expiratory strength training at the conclusion of each EP session. RST devices (Orygen Dual Valve, Forumed SL) provide up to 70 cm H2O of inspiratory and 80 cm H2O of expiratory pressure threshold loads. RST bouts include 5 sets of 5 maximal volume and speed breaths of both inspiratory and expiratory muscle training 2 times during each session. The initial intensity will be 25% of the maximal inspiratory and expiratory pressures the subject can generate. In terms of progression, the inspiratory setting of the training device will be increased up to 10% of the training load from the first set each session, to achieve a rate of perceived exertion of 6-8 (Modified 10-point Borg scale) [29] with complete valve opening. Expiratory settings will be progressed similarly.
RRT Group
RRT will consist of bouts of relaxation breathing at the start and conclusion of each EP session. Participants will be guided to breathe slowly through a respiratory training device (Threshold PEP, Respironics), with minimal resistance. RRT bouts include 5 sets of 5 breaths, 2 times during the session. While the effects of relaxation breathing exercises may include a modest lowering of systolic blood pressure in some hypertensive patients [30], this group serves as an active control. In terms of progression, there will be no progression for this group.
Journal of Pulmonary & Respiratory Medicine: A Review on Respiratory Muscle Training Devices
Advances in Comprehensive Pulmonary Rehabilitation for COPD Patients
European Journal of Heart Failure
Expert Reviews