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

NCT04592718 | Completed

• 1 other identifier: 1655312
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal System--Abnormalities; Anxiety; Visceral Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in 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

  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

  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)

  The intervention will last 4 weeks. Ln RMSSD will be assessed before the intervention begins, and at the end of the intervention.

Study Arms (3)

Slow deep breathing plus breath counting

EXPERIMENTAL

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

Normal-paced breathing plus breath counting

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Participants in this group will serve as a control and will not do any breathing exercises or breath counting.

Interventions

Slow deep breathing plus breath counting BEHAVIORAL

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.

Slow deep breathing plus breath counting

Normal-paced breathing plus breath counting BEHAVIORAL

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.

Normal-paced breathing plus breath counting

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Old Dominion University: lead

Study Sites (1)

Human Performance Laboratory

Norfolk, Virginia, 23529, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Visceral Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Wilson

  Old Dominion University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Exercise Science

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: October 20, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)