Clinical trial NCT05084313: Acute Effects of Deep-Slow Breathing Exercise and Cranial-Visceral Manual Therapy on ANS Parameters in Healthy Adults
Official title: Acute Effects of Deep-Slow Breathing Exercise and Cranial-Visceral Manual Therapy on ANS Parameters in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Nervous System
Keywords: Deep-slow breathing, manual therapy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are three groups in the study, two of which includes interventions, and one group constitutes the control group. The participants will be randomized into groups with a sealed envelope. There is only one session of the allocated intervention for the particular participant, since the study aims to measure acute effects of cranial and visceral manual therapy on autonomic nervous system parameters.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Inter-beat interval (IBI)
timeFrame: 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.
measure: Change in Standard deviation of Normal-to-Normal intervals (SDNN)
timeFrame: 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.
measure: Change in pNN50 (The percentage of adjacent Normal-to-Normal intervals that differ from each other by more than 50 ms as percentage )
timeFrame: 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.
measure: Change in RMSSD
timeFrame: 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.
measure: Change in Total power
timeFrame: 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.
measure: Change in HF band power and LF band power
timeFrame: 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.
measure: LF/HF Ratio
timeFrame: 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.
measure: Galvanic Skin Response
timeFrame: 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.
measure: SD1
timeFrame: 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.
measure: SD2
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Research Hospital- Dpt. of Exercise and Sports Medicine
city: Izmir
country: Turkey
facility: Ege University Research Hospital
Study officials:
affiliation: Ege University Research Hospital- Dpt. of Exercise and Sports Medicine
name: ihsan yoruk, MD
role: PRINCIPAL_INVESTIGATOR
References: