Diaphragmatic Breathing and Heart Rate Variability Training for Improving Hypertension in Fragile X Associated Tremor/Ataxia

NCT03816540 | Completed Phase 3

• 1 other identifier: 1151848
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To study whether heart rate variability training and respiratory coherence can improve hypertension in individuals with FXTAS. 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.

Conditions

Hypertension; FXTAS

Outcome Measures

Primary Outcomes (3)

• Change in blood pressure (systolic & diastolic)

  Blood pressure is measured at the brachial artery of left arm using an electronic blood pressure monitor with an inflatable cuff, repeated three times at each site, and averaged. Less than 120/80 mmHg is considered "normal," 120/80 to 139/89 mmHg is "prehypertension," and above 140/90 mmHg is "hypertension."

  Baseline, 4 to 6 weeks

• Clinical Global Impression Scale - Severity (CGI-S)

  The CGI-Severity (CGI-S) will be assessed at baseline according to the severity of hypertension, which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline elevated; 3=mildly elevated; 4=moderately elevated; 5=markedly elevated; 6=severely elevated; 7= extremely elevated. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. Symptoms and behavior can fluctuate over a week; the score should reflect the average severity level across the seven days.

  Baseline

• Clinical Global Impression Scale - Improvement (CGI-I)

  The CGI-Improvement (CGI-I) is similar to the CGI-S. Directly post-treatment and at the follow-up, the investigator compares the patient's overall clinical condition to the one week period just prior to the baseline visit. The query hypertension is rated on a seven-point scale: "Compared to the patient's condition at baseline, this participant's condition is: 1=very much improved since the baseline; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse since the baseline measure.

  4 to 6 weeks

Secondary Outcomes (4)

• Psychophysiological Profile - Heart Rate Variability (HRV)

  4 to 6 weeks

• Psychophysiological Profile - Synchrony between Respiration and HRV

  4 to 6 weeks

• Psychophysiological Profile - Skin Conductance

  4 to 6 weeks

• Mini-Mental State Examination (MMSE)

  4 to 6 weeks

Study Arms (2)

FXTAS-affected

EXPERIMENTAL

FXTAS-affected participants will receive HRV and respiratory coherence biofeedback training for 20 sessions.

Device: HRV and respiratory coherence biofeedback

FXTAS-unaffected

ACTIVE COMPARATOR

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.

Device: HRV and respiratory coherence biofeedback

Interventions

HRV and respiratory coherence biofeedback DEVICE

Biofeedback treatment to support self-regulatory processes on the physiological level: heart rate variability (HRV) and respiratory coherence.

FXTAS-affected; FXTAS-unaffected

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between the ages of 50-90 with a molecular documentation of a fragile X premutation, diagnosed with FXTAS.
• stable current pharmacological treatment regimen for at least 4 weeks.
• English speaking (the intervention is currently only available in English)
• Clinically significant hypertension.
• Normal or corrected to normal vision and hearing.

You may not qualify if:

• 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)
• Participants who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study
• Individual is non-verbal (has no spoken language)
• English is not the primary language.
• Clinically critical Hypertension that requires medical attention

Sponsors & Collaborators

• University of California, Davis: lead
• UC Davis MIND Institute: collaborator
• UC Davis, Mini-Grant Geriatrics: collaborator

Study Sites (1)

University of California, Davis, MIND Institute

Sacramento, California, 95817, United States

Location

Related Publications (7)

• 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.

  PMID: 20559707 BACKGROUND

• 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.

  PMID: 10999236 BACKGROUND

• 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.

  PMID: 20653294 BACKGROUND

• 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.

  PMID: 22528549 BACKGROUND

• 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.

  PMID: 1940025 BACKGROUND

• 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.

  PMID: 8598068 BACKGROUND

• 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.

  PMID: 825150 BACKGROUND

MeSH Terms

Conditions

Hypertension; Fragile X Tremor Ataxia Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Same intervention will be applied to FXTAS-affected and unaffected (comparison) participants.

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: January 25, 2019
• Study Start: May 1, 2018
• Primary Completion: March 13, 2019
• Study Completion: March 13, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)