Four-week Breathing Interventions on Gut Symptoms, Heart Rate Variability, and Psychological Measures in Runners

Anxiety Clinical Trial

Official title:

The Effects of Four-week Breathing Interventions on Gastrointestinal Symptoms, Heart Rate Variability, and Psychological Measures in Runners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592718
• Other study ID #: 1655312
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Old Dominion University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recent research has suggested that stress and anxiety levels are associated with gastrointestinal (GI) symptoms in endurance athletes (runners, cyclists, triathletes). Yet, there has been limited attempt to evaluate whether GI symptoms during running can be mitigated by interventions designed to reduce stress and anxiety. Thus, this study will evaluate the effects of four-week slow deep breathing and mindful breath counting interventions on subjective and objective measures of stress/anxiety and GI symptoms in runners with mild-to-high anxiety and that are prone to GI symptoms during runs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age
• Run at least 15 miles per week
• Access to internet
• Access to a smart phone that is compatible with iOS or Android applications
• Score at least a 5 on the GAD-7
• Report to have experienced GI symptoms "sometimes", "often" or "always" during runs in the previous month.
• If on a psychotropic medication, must be on a stable dose for the past 3 months.
• Live within the contiguous United States

Exclusion Criteria:

• Younger than 18 years
• Run less than 15 miles per week
• Do not have access to the internet
• Do not have access to a smart phone that is compatible with iOS or Android applications
• Score less than 5 on the GAD-7
• Report to have "never" or "rarely" experienced GI symptoms during runs in the previous month
• Are being prescribed a psychotropic medication and have not had a stable dose for at least three months.
• Do not live within the contiguous United States

Related Conditions & MeSH terms

• Anxiety
• Gastrointestinal System--Abnormalities
• Visceral Pain

Intervention

Behavioral:
• Slow deep breathing plus breath counting
Participants will perform a daily 5-min slow deep breathing exercise for 4 weeks. A breathing rate of 6 breaths per minute will be targeted. In addition, participants will count their breaths during the exercise.
• Normal-paced breathing plus breath counting
Participants will perform a daily 5-min normal-paced breathing exercise for 4 weeks. A breathing rate of 15 breaths per minute will be targeted. In addition, participants will count their breaths during the exercise.

Locations

Country	Name	City	State
United States	Human Performance Laboratory	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Old Dominion University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gastrointestinal symptom occurrence	Percentage of training runs that runners experience at least 1 gastrointestinal symptom (>2 on 0-10 scale).	The intervention will last 4 weeks. Gastrointestinal symptoms will be collected for a 1-week period before the intervention and during the 4th week of the intervention.
Primary	Change in anxiety levels	Levels of anxiety will be assessed with the General Anxiety Disorder-7 questionnaire. Scores on the General Anxiety Disorder-7 range from 0 to 21, with higher scores indicating higher levels of anxiety.	The intervention will last 4 weeks. The General Anxiety Disorder-7 will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.
Secondary	Change in visceral sensitivity	Perceptions of visceral sensitivity will be assessed via the Visceral Sensitivity Index. Scores on the Visceral Sensitivity Index can range from 0 to 75, with higher scores indicating a higher level of visceral sensitivity.	The intervention will last 4 weeks. The Visceral Sensitivity Index will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.
Secondary	Change in mindfulness	Perceptions of mindfulness will be assessed via the 15-item Five Facet Mindfulness Questionnaire. Scores on the Five Facet Mindfulness Questionnaire can range from 15-75, with higher scores indicating higher levels of mindfulness.	The intervention will last 4 weeks. The Five Facet Mindfulness Questionnaire will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.
Secondary	Change in body vigilance	Perceptions of body vigilance will be assessed via the Body Vigilance Scale. Scores on the Body Vigilance Scale can range from 0-40, with higher levels meaning greater amounts of body vigilance.	The intervention will last 4 weeks. The Body Vigilance Scale will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.
Secondary	Change in heart rate variability (Ln RMSSD)	Heart rate variability will be assessed via a portable fingertip monitor (CorSense) and quantified as the Ln root mean square of successive differences (Ln RMSSD) between normal heartbeats.	The intervention will last 4 weeks. Ln RMSSD will be assessed before the intervention begins, and at the end of the intervention.