Diaphragmatic Breathing and Heart Rate Variability Training for Improving Hypertension in Fragile X Associated Tremor/Ataxia
NCT ID: NCT03816540
Last Updated: 2019-10-22
Study Results
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Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2018-05-01
2019-03-13
Brief Summary
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All patients will receive HRV biofeedback training for 20 sessions. Our hypothesis is that individuals with FXTAS who undergo 20 sessions of biofeedback training will improve self-regulatory skills for reducing hypertension, as measured by blood pressure measurement to below 140/90. The investigators hypothesize that individuals who successfully develop increased heart rate variability and better synchrony between heart rhythm and respiration will show the greatest improvements in self-regulatory skills for hypertension.
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Detailed Description
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Chronic hypertension contributes to cardiovascular complications, dementia, and increased risk of stroke. Our results indicate that the risk of hypertension is significantly elevated in male premutation carriers with FXTAS compared with carriers without FXTAS and controls.
Several research studies showed high levels of physiological arousal in individuals with Fragile X-Associated Disorders (FXS/FX-AD), related to a dysregulation of the sympathetic and parasympathetic nervous system. One parameter to measure physiological arousal is cardiovascular activity. It provides an index of parasympathetic and sympathetic involvement of the autonomic nervous system. Heart rate is under the control of efferent sympathetic and vagal activities directed to the sinus node, which are modulated by central brain stem (vasomotor and respiratory centers) and peripheral oscillators (oscillation in arterial pressure and respiratory movements). Spectral analysis of heart rate variability (HRV) is a reliable quantitative method for analyzing the modulatory effects of neural mechanisms on the sinus node.
Biofeedback treatments are reported for over 30 years. Biofeedback provides specific information about internal biological processes (i.e. muscle activity, respiration, heart rate variability, skin temperature and brain electrical activity) in an individual. In general, by enhancing the awareness of these processes and training to volitional control over them, specific parameters can be improved. The internal biological processes can be measured with a specific biofeedback equipment that convert this data into signals, often in the form of auditory, visual or somatosensory events, so that the individual can perceive real-time changes in their physiological activity. As the individual learns to control these events, healthier physiological processes are conditioned. Depending upon the physiological processes targeted, healthier patterns of activity can be achieved by most people after they have participated in 10 to 50 sessions of biofeedback supported with professional coaching and practice. Various biofeedback protocols and assistive electronic technologies such as the NeXus-10, emWave Personal Stress Reliever® or StressEraser® exist to enhance the balance of parasympathetic activity, vagal tone, increase HRV and synchronize respiration with the heart rhythm (i.e., the slowing down and speeding up of the heart over time).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FXTAS-affected
FXTAS-affected participants will receive HRV and respiratory coherence biofeedback training for 20 sessions.
HRV and respiratory coherence biofeedback
Biofeedback treatment to support self-regulatory processes on the physiological level: heart rate variability (HRV) and respiratory coherence.
FXTAS-unaffected
FXTAS-unaffected participants will be assessed to compare the effects of biofeedback based on FXTAS status. This arm will receive HRV and respiratory coherence biofeedback training for 20 sessions.
HRV and respiratory coherence biofeedback
Biofeedback treatment to support self-regulatory processes on the physiological level: heart rate variability (HRV) and respiratory coherence.
Interventions
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HRV and respiratory coherence biofeedback
Biofeedback treatment to support self-regulatory processes on the physiological level: heart rate variability (HRV) and respiratory coherence.
Eligibility Criteria
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Inclusion Criteria
2. stable current pharmacological treatment regimen for at least 4 weeks.
3. English speaking (the intervention is currently only available in English)
4. Clinically significant hypertension.
5. Normal or corrected to normal vision and hearing.
Exclusion Criteria
2. Participants who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study
3. Individual is non-verbal (has no spoken language)
4. English is not the primary language.
5. Clinically critical Hypertension that requires medical attention
50 Years
90 Years
ALL
Yes
Sponsors
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UC Davis MIND Institute
UNKNOWN
UC Davis, Mini-Grant Geriatrics
UNKNOWN
University of California, Davis
OTHER
Responsible Party
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Locations
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University of California, Davis, MIND Institute
Sacramento, California, United States
Countries
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References
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Bradley RT, McCraty R, Atkinson M, Tomasino D, Daugherty A, Arguelles L. Emotion self-regulation, psychophysiological coherence, and test anxiety: results from an experiment using electrophysiological measures. Appl Psychophysiol Biofeedback. 2010 Dec;35(4):261-83. doi: 10.1007/s10484-010-9134-x.
Lehrer PM, Vaschillo E, Vaschillo B. Resonant frequency biofeedback training to increase cardiac variability: rationale and manual for training. Appl Psychophysiol Biofeedback. 2000 Sep;25(3):177-91. doi: 10.1023/a:1009554825745.
Lloyd A, Brett D, Wesnes K. Coherence training in children with attention-deficit hyperactivity disorder: cognitive functions and behavioral changes. Altern Ther Health Med. 2010 Jul-Aug;16(4):34-42.
Hamlin AA, Sukharev D, Campos L, Mu Y, Tassone F, Hessl D, Nguyen DV, Loesch D, Hagerman RJ. Hypertension in FMR1 premutation males with and without fragile X-associated tremor/ataxia syndrome (FXTAS). Am J Med Genet A. 2012 Jun;158A(6):1304-9. doi: 10.1002/ajmg.a.35323. Epub 2012 Apr 23.
Pagani M, Rimoldi O, Pizzinelli P, Furlan R, Crivellaro W, Liberati D, Cerutti S, Malliani A. Assessment of the neural control of the circulation during psychological stress. J Auton Nerv Syst. 1991 Jul;35(1):33-41. doi: 10.1016/0165-1838(91)90036-3.
Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
Lubar JF, Bahler WW. Behavioral management of epileptic seizures following EEG biofeedback training of the sensorimotor rhythm. Biofeedback Self Regul. 1976 Mar;1(1):77-104. doi: 10.1007/BF00998692.
Other Identifiers
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1151848
Identifier Type: -
Identifier Source: org_study_id
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