Acute Effects of HRV-Biofeedback Training and Cranial-Visceral Therapy on ANS Parameters in Healthy Adults

Overview

The purpose of this study is to evaluate the effects of several manual therapy techniques on autonomic nervous system and to compare it with other groups in the study such as heart rate variability bio-feedback group and the control group. The measurements will take place right before and after the intervention to evaluate the effects of one single intervention.

Full Title of Study: “Acute Effects of HRV-Biofeedback Training and Cranial-Visceral Manual Therapy on Heart Rate Variability and Autonomic Nervous System Parameters in Healthy Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2022

Detailed Description

All the patients will be clearly informed and will be included in the present study after their informed consent. The autonomic nervous system (ANS) will be evaluated using bio-sensors such as Photoplethysmography (PPG) and Galvanic skin response (GSR). The measurements will take place once for an individual. There will be three groups consisted of manual therapy, bio-feedback and control groups. Non-invasive cranial and visceral techniques will be applied on the manual therapy group. The bio-feedback group will get an intervention consisting of deep-paced breathing to increase cardiac harmony.The control group will rest for the same amount of time as other interventions to distinguish whether the changes are related to intervention. After given consent, the participant will be assigned randomly to one of three groups. All the participants will be subjected to baseline measurement of the abovementioned metrics prior to intervention. All the interventions will take place in a controlled setting. After baseline measurement, the participant will take one of the three interventions which will take 30 minutes. After the data for each person is captured via sensors, it will be stored on a personal computer for further analysis and interpretation. According to investigator's hypothesis, bio-feedback group will show signs of sympathetic withdrawal and parasympathetic dominance and that manual therapy group will also show same autonomic shift too.

Interventions

  • Other: Manual Therapy
    • This group of patients will receive manual therapy techniques to harmonize vegetative nervous system. PPG and GSR will be recorded during the intervention. The techniques consist of suboccipital decompression, rib raising, diaphragm, larynx and mediastinum mobilisation, sternocleidomastoid muscle fascial release and occipito-mastoid suture release. All intervention is planned to take approximately 20 minutes.The group will include 40 healthy individuals.
  • Other: Bio-feedback
    • Patients in this group will do slow paced breathing while getting visual and auditory feedback about their ppg and heart rate variability in a sitting position. The patients will be able to cease the session in case of feeling uncomfortable. The main purpose will be that the individuals should breath 6 breaths per minute to increase respiratory sinus arrhythmia which is also reflected at PPG waveforms and in reduction in GSR. The group will include 40 healthy individuals.
  • Other: Control
    • Control group patients will be attached to the sensors and they will rest in a quiet and controlled indoor environment without any intervention. The aim of including this group is to to understand whether the parasympathetic effects expected in the manual therapy group were due to the intervention. The group will include 40 healthy individuals.

Arms, Groups and Cohorts

  • Experimental: Manual therapy group
    • This group of patients will receive manual therapy techniques to harmonize vegetative nervous system. PPG and GSR will be recorded during the intervention. The techniques consist of suboccipital decompression, rib raising, diaphragm, larynx and mediastinum mobilisation, sternocleidomastoid muscle fascial release and occipito-mastoid suture release. All intervention is planned to take approximately 20 minutes.The group will include 40 healthy individuals.
  • Active Comparator: Biofeedback group
    • Patients in this group will do slow paced breathing while getting visual and auditory feedback about their ppg and heart rate variability in a sitting position. The patients will be able to cease the session in case of feeling uncomfortable. The main purpose will be that the individuals should breath 6 breaths per minute to increase respiratory sinus arrhythmia which is also reflected at PPG waveforms and in reduction in GSR. The group will include 40 healthy individuals.
  • Other: Control
    • Control group patients will be attached to the sensors and they will rest in a quiet and controlled indoor environment without any intervention. The aim of including this group is to to understand whether the parasympathetic effects expected in the manual therapy group were due to the intervention. The group will include 40 healthy individuals.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Inter-beat interval (IBI)
    • Time Frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point-0. Average of last 5 minute epoch as time point-1 and average of 5 min epoch right after the intervention as time point-2.
    • Inter-beat interval is the recorded physiological parameter and defined as the time interval between consecutive R wave peaks in milliseconds which will be obtained via photoplethysmography device and the relevant further analysis will be carried on in a software which was shown to be valid and reliable in a clinical research setting.
  • Change in Standard deviation of Normal-to-Normal intervals (SDNN)
    • Time Frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point-0. Average of last 5 minute epoch as time point-1 and average of 5 min epoch right after the intervention as time point-2.
    • The standard deviation of Normal-to-Normal IBI of normal sinus beats in milliseconds.
  • Change in pNN50 (The percentage of adjacent Normal-to-Normal intervals that differ from each other by more than 50 ms as percentage )
    • Time Frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point-0. Average of last 5 minute epoch as time point-1 and average of 5 min epoch right after the intervention as time point-2.
    • The percentage of adjacent Normal-to-Normal intervals that differ from each other by more than 50 ms as percentage (%).
  • Change in RMSSD
    • Time Frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point-0. Average of last 5 minute epoch as time point-1 and average of 5 min epoch right after the intervention as time point-2.
    • The root mean square of successive differences between normal (sinus) heartbeats in milliseconds.
  • Change in Total power
    • Time Frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point-0. Average of last 5 minute epoch as time point-1 and average of 5 min epoch right after the intervention as time point-2.
    • Total power is the sum of the energy in the Low Frequency and High Frequency bands’ spectral power for short-term recordings in units of ms2.
  • Change in HF band power and LF band power
    • Time Frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point-0. Average of last 5 minute epoch as time point-1 and average of 5 min epoch right after the intervention as time point-2.
    • Spectral analysis of High Frequency band (Absolute power of the high-frequency band (0.15-0.4 Hz)) reflects parasympathetic activity and Spectral analysis Low Frequency band Absolute power of the low-frequency band (0.04-0.15 Hz)reflects baroreflex activity.These parameters will be calculated both as absolute (ms2) and relative units. Relative power is estimated as the percentage of total Heart Rate Variability (HRV) power or in normal units (nu), which divides the absolute power for a specific frequency band by the summed absolute power of the LF and HF bands in normalised units (nu).
  • LF/HF Ratio
    • Time Frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point-0. Average of last 5 minute epoch as time point-1 and average of 5 min epoch right after the intervention as time point-2.
    • may estimate the ratio between sympathetic nervous system (SNS) and parasympathetic nervous system (PNS) activity under controlled conditions in units of ms2.
  • Galvanic Skin Response
    • Time Frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point-0. Average of last 5 minute epoch as time point-1 and average of 5 min epoch right after the intervention as time point-2.
    • Electrical conductance between two electrodes attached on 2 fingers of the individual in units of micro-Siemens (μS).
  • SD1
    • Time Frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point-0. Average of last 5 minute epoch as time point-1 and average of 5 min epoch right after the intervention as time point-2.
    • SD1 is one of the non-linear HRV measure and defined as Poincaré plot standard deviation perpendicular the line of identity. It measures short-term Heart Rate Variability in milliseconds and correlates with baroreflex sensitivity (BRS), which is the change in IBI duration per unit change in BP, and HF (high frequency) power.
  • SD2
    • Time Frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point-0. Average of last 5 minute epoch as time point-1 and average of 5 min epoch right after the intervention as time point-2.
    • SD2 is one of the non-linear HRV measure and defined as Poincaré plot standard deviation along the line of identity. It measures short- and long-term HRV in milliseconds and correlates with LF power and baroreflex sensitivity (BRS).

Participating in This Clinical Trial

Inclusion Criteria

  • To be between 18- 30 years old. – To volunteer to participate in the study – Not engaging in regular exercise. – Not to have a chronical disease or history of chronical disease. – Not to take any medication. Exclusion Criteria:

  • Being outside of the range of 18- 30 years old. – To have any kind of medical condition that disturbs the autonomic nervous system – To have a chronical disease – To have a regular medication – To have/had head injury, intracranial bleeding or increased intracranial pressure.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ege University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ihsan Yoruk, Assistant Researcher Dr. Ihsan Yoruk – Ege University
  • Overall Official(s)
    • ihsan yoruk, MD, Principal Investigator, Ege University Research Hospital- Dpt. of Exercise and Sports Medicine
  • Overall Contact(s)
    • ihsan yoruk, +90532 621 92 79, drihsanyoruk@gmail.com

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