Relaxation Effects of Personalized Breathing Exercises for Healthy College Students

Breathing Exercises Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06121596
• Other study ID #: P-BP-40-60-80-RCT
• Status: Completed
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: November 27, 2023

Study information

• Verified date: January 2024
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breathing Exercises
• Respiratory Aspiration

Intervention

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).

Locations

Country	Name	City	State
Germany	Technical University of Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	Peripheral Temperature	Measured via temperature sensor on the small finger	During the 5-minute baseline measurement and during each 5-minute breathing exercise
Secondary	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
Secondary	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