Relaxation Effects of Personalized Breathing Exercises for Healthy College Students

Sponsor
Technical University of Munich (Other)
Overall Status
Recruiting
CT.gov ID
NCT06121596
Collaborator
(none)
42
1
3
4
10.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Breathing Exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Relaxation Effects of Personalized Breathing Exercises for Healthy College Students: A Randomized Crossover Trial
Actual Study Start Date :
Jul 31, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. General Relaxation Score [Immediately after the 5-minute baseline measurement and immediately after each 5-minute breathing exercise]

    Measured with the German Version of the Relaxation State Questionnaire

Secondary Outcome Measures

  1. Current Perceived Stress Level [Immediately after the 5-minute baseline measurement and immediately after each 5-minute breathing exercise]

    Measured on a visual analog scale ranging from 0 to 100, where zero is absolutely no stress and 100 is extreme stress.

  2. Heart Rate Variability [During the 5-minute baseline measurement and during each 5-minute breathing exercise]

    Measured via blood volume pulse with a finger clip on the middle finger

  3. Peripheral Temperature [During the 5-minute baseline measurement and during each 5-minute breathing exercise]

    Measured via temperature sensor on the small finger

  4. Skin Conductance [During the 5-minute baseline measurement and during each 5-minute breathing exercise]

    Measured via skin conductance sensor on the index and ring finger

  5. Power in Frequency Bands [During the 5-minute baseline measurement and during each 5-minute breathing exercise]

    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

Other Outcome Measures

  1. Breathing Frequency [During the first questionnaire and video-based instructions before the baseline measurement, the 5-minute baseline measurement and during each 5-minute breathing exercise]

    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.

  2. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [Immidiately after the last breathing exercise]

    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.

  3. Difficulty with any of the Breathing Exercises [Immidiately after the last breathing exercise]

    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.

  4. Transferability of Breathing Exercises into Daily Life [Immidiately after the last breathing exercise]

    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.

  5. One Word Description for Breathing Exercises [Immidiately after the last breathing exercise]

    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.

  6. Previous Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.) [Immidiately after the last breathing exercise]

    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.

  7. Duration of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.) [Immidiately after the last breathing exercise]

    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.

  8. Average Volume of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.) [Immidiately after the last breathing exercise]

    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.

  9. Stress, Anxiety and Depression Score of the Past Two Weeks [Immidiately after the last breathing exercise]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Technical University of Munich Munich Bavaria Germany 80992

Sponsors and Collaborators

  • Technical University of Munich

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lukas Moebus, Principal Investigator, Technical University of Munich
ClinicalTrials.gov Identifier:
NCT06121596
Other Study ID Numbers:
  • P-BP-40-60-80-RCT
First Posted:
Nov 8, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lukas Moebus, Principal Investigator, Technical University of Munich
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2023