Diaphragmatic Breathing and Heart Rate Variability Training for Improving Hypertension in Fragile X Associated Tremor/Ataxia
Paraules clau
Resum
Descripció
Fragile X-associated tremor ataxia syndrome (FXTAS) is a late onset neurodegenerative disease that affects carriers of the fragile X premutation. This project proposes the evaluation of an innovative intervention program that promotes self-regulatory skills for hypertension in individuals with FXTAS. Using a control-group experimental design, the investigators propose to explore the efficacy of a biofeedback treatment to support self-regulatory processes on the physiological level: Heart Rate Variability (HRV) and respiratory coherence biofeedback.
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).
Dates
| Darrera verificació: | 09/30/2019 |
| Primer enviat: | 05/07/2018 |
| Inscripció estimada enviada: | 01/22/2019 |
| Publicat per primera vegada: | 01/24/2019 |
| Última actualització enviada: | 10/17/2019 |
| Publicació de l'última actualització: | 10/21/2019 |
| Data d'inici de l'estudi real: | 04/30/2018 |
| Data estimada de finalització primària: | 03/12/2019 |
| Data estimada de finalització de l’estudi: | 03/12/2019 |
Condició o malaltia
Intervenció / tractament
Device: HRV and respiratory coherence biofeedback
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: FXTAS-affected FXTAS-affected participants will receive HRV and respiratory coherence biofeedback training for 20 sessions. | |
| Active Comparator: 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. |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 50 Years Per a 50 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: 1. Males and females between the ages of 50-90 with a molecular documentation of a fragile X premutation, diagnosed with FXTAS. 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: 1. Significant medical and behavioral problems that would interfere with the study (e.g. not being able to sit and play a computer game for 10 minutes) 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 |
Resultat
Mesures de resultats primaris
1. Change in blood pressure (systolic & diastolic) [Baseline, 4 to 6 weeks]
2. Clinical Global Impression Scale - Severity (CGI-S) [Baseline]
3. Clinical Global Impression Scale - Improvement (CGI-I) [4 to 6 weeks]
Mesures de resultats secundaris
1. Psychophysiological Profile - Heart Rate Variability (HRV) [4 to 6 weeks]
2. Psychophysiological Profile - Synchrony between Respiration and HRV [4 to 6 weeks]
3. Psychophysiological Profile - Skin Conductance [4 to 6 weeks]
4. Mini-Mental State Examination (MMSE) [4 to 6 weeks]
