Skip to main content
OpenTrials
Completed

NCT Number: NCT05084313

Acute Effects of Deep-Slow Breathing Exercise and Cranial-Visceral Manual Therapy on ANS Parameters in Healthy Adults

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 deep-slow breathing group and the control group. The measurements will take place right before and after the intervention to evaluate the effects of one single intervention.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autonomic Nervous System

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Research Hospital, Izmir, Turkey (Türkiye)

Loading trial locations.

About this study

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, deep-slow breathing, and control groups. Non-invasive cranial and visceral techniques will be applied on the manual therapy group. The deep-slow breathing 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, deep-slow breathing group will show signs of sympathetic withdrawal and parasympathetic dominance and that manual therapy group will also show same autonomic shift too.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 that affects heart rate variability.

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.

Treatment and study plan

Manual therapy

Other

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 CV-4 technique, suboccipital decompression, lumbo-sacral decompression, release of the transverse diaphragms, frontal lift technique, parietal lift technique, temporal techniques, temporo-mandibular joint myofascial release, deep cervical fasciae technique as described in Upledger's protocol. In addition to the protocol; rib raising technique, larynx and sternocleidomastoid muscle fascial release and occipito-mastoid suture release will be applied. All intervention is planned to take approximately 20 minutes. The group will include forty healthy individuals.

Deep-slow breathing

Other

Patients in this group will do slow paced breathing to increase heart rate variability as it can be partially modulated by respiratory effects. The patients will be able to cease the session in case of feeling uncomfortable. The main purpose will be that the individuals should breathe six breaths per minute to increase respiratory sinus arrhythmia which is also reflected at PPG waveforms and in reduction in GSR. The group will include forty healthy individuals.

Control

Other

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 forty healthy individuals.

Primary outcomes

  1. Change in Inter-beat interval (IBI)

    Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of intervention time as time point one and average of 5 min epoch right after the intervention as time point two.

    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.

  2. 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 zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.

    The standard deviation of Normal-to-Normal IBI of normal sinus beats in milliseconds.

  3. 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 zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.

    The percentage of adjacent Normal-to-Normal intervals that differ from each other by more than 50 ms as percentage (%).

  4. Change in RMSSD

    Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.

    The root mean square of successive differences between normal (sinus) heartbeats in milliseconds.

  5. Change in Total power

    Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.

    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.

  6. 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 zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.

    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).

  7. LF/HF Ratio

    Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.

    may estimate the ratio between sympathetic nervous system (SNS) and parasympathetic nervous system (PNS) activity under controlled conditions in units of ms2.

  8. Galvanic Skin Response

    Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.

    Electrical conductance between two electrodes attached on 2 fingers of the individual in units of micro-Siemens (μS).

  9. SD1

    Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.

    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.

  10. SD2

    Time frame: Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two.

    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).

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2021
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.