Clinical trial NCT04592718: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal System--Abnormalities
Anxiety
Visceral Pain
Lead sponsor: Old Dominion University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change in gastrointestinal symptom occurrence
timeFrame: 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.
measure: Change in anxiety levels
timeFrame: 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:
measure: Change in visceral sensitivity
timeFrame: 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.
measure: Change in mindfulness
timeFrame: 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.
measure: Change in body vigilance
timeFrame: 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.
measure: Change in heart rate variability (Ln RMSSD)
timeFrame: The intervention will last 4 weeks. Ln RMSSD will be assessed before the intervention begins, and at the end of the intervention.
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Human Performance Laboratory
state: Virginia
Study officials:
affiliation: Old Dominion University
name: Patrick Wilson
role: PRINCIPAL_INVESTIGATOR
References: