Relaxation Effects of Personalized Breathing Exercises for Healthy College Students

NCT06121596 | Completed

• 1 other identifier: P-BP-40-60-80-RCT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Breathing Exercises

Keywords

Relaxation therapy; Stress-management; Breathing exercise; Stress; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Relaxation Sum Score

  Measured with the German Version of the Relaxation State Questionnaire; Sum scores range from 10 to 50 (higher scores indicate greater relaxation).

  Immediately after each 5-minute breathing exercise

Secondary Outcomes (5)

• Current Perceived Stress Level

  Immediately after each 5-minute breathing exercise

• Heart Rate Variability

  During each 5-minute breathing exercise

• Peripheral Temperature

  During each 5-minute breathing exercise

• Skin Conductance

  During each 5-minute breathing exercise

• Power in Frequency Bands

  During each 5-minute breathing exercise

Other Outcomes (9)

• 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

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  Immidiately after the last breathing exercise

• Difficulty with any of the Breathing Exercises

  Immidiately after the last breathing exercise

Study Arms (3)

Breathing Exercise with 40 Percent of the Spontaneous Breathing Frequency (A)

EXPERIMENTAL

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

Breathing Exercise with 60 Percent of the Spontaneous Breathing Frequency (B)

EXPERIMENTAL

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

Breathing Exercise with 80 Percent of the Spontaneous Breathing Frequency (C)

EXPERIMENTAL

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

Interventions

Breathing Exercise BEHAVIORAL

A breathing exercise is a relaxation technique (or therapy) to increase relaxation (induces a relaxation response) and decrease stress (reduces a stress response).

Breathing Exercise with 40 Percent of the Spontaneous Breathing Frequency (A); Breathing Exercise with 60 Percent of the Spontaneous Breathing Frequency (B); Breathing Exercise with 80 Percent of the Spontaneous Breathing Frequency (C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Technical University of Munich

Munich, Bavaria, 80992, Germany

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Lukas Moebus, M.Sc.

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: November 8, 2023
• Study Start: July 31, 2023
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)