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

NCT ID: NCT05084313

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-06-01

Brief Summary

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.

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, 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.

Conditions

Autonomic Nervous System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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 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 40 healthy individuals.

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: 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 group

Patients in this group will do deep-slow paced breathing exercise. 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.

Group Type: ACTIVE_COMPARATOR

Deep-slow breathing

Intervention Type: 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

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.

Group Type: OTHER

Control

Intervention Type: 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.

Interventions

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 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.

Intervention Type: OTHER

Deep-slow breathing

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.

Intervention Type: 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 forty healthy individuals.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Ihsan Yoruk

Assistant Researcher Dr. Ihsan Yoruk

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ihsan yoruk, MD

Role: PRINCIPAL_INVESTIGATOR

Ege University Research Hospital- Dpt. of Exercise and Sports Medicine

Locations

Ege University Research Hospital- Dpt. of Exercise and Sports Medicine

Izmir, , Turkey (Türkiye)

Ege University Research Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TTU-2021-22675

Identifier Type: -

Identifier Source: org_study_id