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NCT Number: NCT04592718

Four-week Breathing Interventions on Gut 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.

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Key information

Conditions

Gastrointestinal System--Abnormalities Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Visceral Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Performance Laboratory

Norfolk, Virginia, 23529, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in gastrointestinal symptom occurrence

    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.

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

  2. Change in anxiety levels

    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.

    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 outcomes

  1. Change in visceral sensitivity

    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.

    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.

  2. Change in mindfulness

    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.

    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.

  3. Change in 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.

    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.

  4. Change in heart rate variability (Ln RMSSD)

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

    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.

Sponsors and collaborators

Lead sponsor

Old Dominion University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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