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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Visceral Pain; Gastrointestinal System--Abnormalities
• Intervention / Treatment: Behavioral: Slow deep breathing plus breath counting; Behavioral: Normal-paced breathing plus breath counting

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23529
      • Human Performance Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Slow deep breathing plus breath counting; Participants in this group will do a daily 5-min slow deep breathing exercise (6 breaths/minute) and will also count their breaths	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.
ACTIVE_COMPARATOR: Normal-paced breathing plus breath counting; Participants in this group will do a daily 5-min normal-paced breathing (15 breaths/minute) and will also count their breaths	Behavioral: 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.
NO_INTERVENTION: Control; Participants in this group will serve as a control and will not do any breathing exercises or breath counting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Old Dominion University
• Investigators: Principal Investigator: Patrick Wilson, Old Dominion University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2020
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nociceptive Pain; Visceral Pain
• Other Study ID Numbers: 1655312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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