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

NCT ID: NCT04592718

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal System--Abnormalities Anxiety Visceral Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Slow deep breathing plus breath counting

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Normal-paced breathing plus breath counting

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Old Dominion University

OTHER

Sponsor Role lead

Responsible Party

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Patrick Wilson, PhD

Associate Professor of Exercise Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Wilson

Role: PRINCIPAL_INVESTIGATOR

Old Dominion University

Locations

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Human Performance Laboratory

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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1655312

Identifier Type: -

Identifier Source: org_study_id

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