Relaxation Effects of Personalized Breathing Exercises for Healthy College Students

Relaxation Effects of Personalized Breathing Exercises for Healthy College Students: A Randomized Crossover Trial

Stress plays a major role in the etiology and pathogenesis of anxiety and depression. Relaxation therapies, such as breathing exercises, can reduce stress and increase relaxation.

This study has two aims. First, it aims to personalize and optimize breathing protocols. Second, it aims to tailor breathing protocols to subgroups based on prediction models of expected efficacy.

Three different breathing protocols, varying solely in their instructed breathing frequency with 40 percent (A), 60 percent (B), and 80 percent (C) of the interindividual spontaneous breathing frequency, are tested in a randomized, counterbalanced crossover trial. Other parameters, such as breathing quality (i.e., nasal and diaphragmatic), rhythm (i.e., prolonged exhalation without instructed pauses) and depth (i.e., increased depth due to slower breathing frequency) as well as contextual factors (e.g., posture, video-based instructions, type of pacer, etc.) are invariant between protocols.

First, this study hypothesizes a difference in the relaxation response between breathing protocols A, B, and C. This study looks at the relaxation response from three different angles (1) self-report, (2) autonomic arousal, and (3) central nervous system arousal. Second, this study explores prediction models of expected efficacy based on the interindividual variance in characteristics (i.e., depressive, anxious and stress symptoms as well as expertise in relaxation therapies) and biomarkers (e.g., heart rate variability, peripheral temperature, skin conductance, etc.). Prediction models can tailor breathing protocols to subgroups to increase expected efficacy.

Study Overview

• Status: Completed
• Conditions: Breathing Exercises
• Intervention / Treatment: Behavioral: Breathing Exercise

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lukas Moebus, M.Sc.; Phone Number: +498928924542; Email: lukas.moebus@tum.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80992
      • Technical University of Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Above 18 years old
• University student
• Native German speaker

Exclusion Criteria:

• Any psychiatric (e.g., anxiety), neurologic (e.g., epilepsy) or cardio-pulmonary (e.g., asthma) diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breathing Exercise with 40 Percent of the Spontaneous Breathing Frequency (A); Participants are instructed (via visual pacer) to reduce their breathing frequency to 40 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise.	Behavioral: Breathing Exercise; A breathing exercise is a relaxation technique (or therapy) to increase relaxation (induces a relaxation response) and decrease stress (reduces a stress response).
Experimental: Breathing Exercise with 60 Percent of the Spontaneous Breathing Frequency (B); Participants are instructed (via visual pacer) to reduce their breathing frequency to 60 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise.	Behavioral: Breathing Exercise; A breathing exercise is a relaxation technique (or therapy) to increase relaxation (induces a relaxation response) and decrease stress (reduces a stress response).
Experimental: Breathing Exercise with 80 Percent of the Spontaneous Breathing Frequency (C); Participants are instructed (via visual pacer) to reduce their breathing frequency to 80 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise.	Behavioral: Breathing Exercise; A breathing exercise is a relaxation technique (or therapy) to increase relaxation (induces a relaxation response) and decrease stress (reduces a stress response).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relaxation Sum Score	Measured with the German Version of the Relaxation State Questionnaire	Immediately after the 5-minute baseline measurement and immediately after each 5-minute breathing exercise

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current Perceived Stress Level	Measured on a visual analog scale ranging from 0 to 100, where zero is absolutely no stress and 100 is extreme stress.	Immediately after the 5-minute baseline measurement and immediately after each 5-minute breathing exercise
Heart Rate Variability	Measured via blood volume pulse with a finger clip on the middle finger	During the 5-minute baseline measurement and during each 5-minute breathing exercise
Peripheral Temperature	Measured via temperature sensor on the small finger	During the 5-minute baseline measurement and during each 5-minute breathing exercise
Skin Conductance	Measured via skin conductance sensor on the index and ring finger	During the 5-minute baseline measurement and during each 5-minute breathing exercise
Power in Frequency Bands	Measured via four channel EEG with linked earlobe reference and active electrode placement on F3, F4, F7, and F8 according to the international 10-20 system	During the 5-minute baseline measurement and during each 5-minute breathing exercise

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing Frequency	Measured via chest strap sensor. This is not an outcome, it measures the participant's spontaneous breathing frequency and the compliance to the breathing protocols.	During the first questionnaire and video-based instructions before the baseline measurement, the 5-minute baseline measurement and during each 5-minute breathing exercise
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0	Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.	Immidiately after the last breathing exercise
Difficulty with any of the Breathing Exercises	Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.	Immidiately after the last breathing exercise
Transferability of Breathing Exercises into Daily Life	Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.	Immidiately after the last breathing exercise
One Word Description for Breathing Exercises	Assessed with an open question. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.	Immidiately after the last breathing exercise
Previous Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)	Assessed with a closed (Yes/No) question. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.	Immidiately after the last breathing exercise
Duration of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)	Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.	Immidiately after the last breathing exercise
Average Volume of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.)	Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.	Immidiately after the last breathing exercise
Stress, Anxiety and Depression Score of the Past Two Weeks	Measured with the Depression-Anxiety-Stress-Scale Questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises.	Immidiately after the last breathing exercise

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Lukas Moebus, M.Sc., Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Stress; Breathing exercise; Relaxation therapy; Stress-management
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: P-BP-40-60-80-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No