Back to results

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

Primary Purpose

Gastrointestinal System--Abnormalities, Anxiety, Visceral Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Slow deep breathing plus breath counting

Normal-paced breathing plus breath counting

About this trial

This is an interventional basic science trial for Gastrointestinal System--Abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Human Performance Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Slow deep breathing plus breath counting

Normal-paced breathing plus breath counting

Control

Arm Description

Participants in this group will do a daily 5-min slow deep breathing exercise (6 breaths/minute) and will also count their breaths

Participants in this group will do a daily 5-min normal-paced breathing (15 breaths/minute) and will also count their breaths

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

Outcomes

Primary Outcome Measures

Change in gastrointestinal symptom occurrence

Percentage of training runs that runners experience at least 1 gastrointestinal symptom (>2 on 0-10 scale).

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT04592718

First Posted

October 12, 2020

Last Updated

September 7, 2021

Sponsor

Old Dominion University

1. Study Identification

Unique Protocol Identification Number

NCT04592718

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

October 20, 2020 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Old Dominion University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal System--Abnormalities, Anxiety, Visceral Pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Slow deep breathing plus breath counting

Arm Type

Experimental

Arm Description

Participants in this group will do a daily 5-min slow deep breathing exercise (6 breaths/minute) and will also count their breaths

Arm Title

Normal-paced breathing plus breath counting

Arm Type

Active Comparator

Arm Description

Participants in this group will do a daily 5-min normal-paced breathing (15 breaths/minute) and will also count their breaths

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Slow deep breathing plus breath counting

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Normal-paced breathing plus breath counting

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in gastrointestinal symptom occurrence

Description

Percentage of training runs that runners experience at least 1 gastrointestinal symptom (>2 on 0-10 scale).

Time Frame

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.

Title

Change in anxiety levels

Description

Time Frame

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 Measure Information:

Title

Change in visceral sensitivity

Description

Time Frame

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.

Title

Change in mindfulness

Description

Time Frame

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.

Title

Change in body vigilance

Description

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.

Time Frame

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.

Title

Change in heart rate variability (Ln RMSSD)

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Wilson

Organizational Affiliation

Old Dominion University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Human Performance Laboratory

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23529

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs