Gastrointestinal System--AbnormalitiesNCT04592718
Four-week Breathing Interventions on Gut Symptoms, Heart Rate Variability, and Psychological Measures in Runners
A study testing Slow deep breathing plus breath counting and Normal-paced breathing plus breath counting in people with Gastrointestinal System--Abnormalities and Anxiety, run by Old Dominion University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal System--Abnormalities, Anxiety, Visceral Pain
- What is being tested?
- Slow deep breathing plus breath counting and Normal-paced breathing plus breath counting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Performance Laboratory
Norfolk, Virginia, 23529
About this study
Official title: The Effects of Four-week Breathing Interventions on Gastrointestinal 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.
- Being tested
- Slow deep breathing plus breath counting, Normal-paced breathing plus breath counting
- Medical subject headings
- Anxiety Disorders, Visceral Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow deep breathing plus breath countingBehavioural
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 countingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal symptom occurrence
Percentage of training runs that runners experience at least 1 gastrointestinal symptom (>2 on 0-10 scale).
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: The intervention will last 4 weeks. Ln RMSSD will be assessed before the intervention begins, and at the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start20 Oct 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal System--AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Wilson, PhD, Old Dominion University
- Investigators
- Patrick Wilson, Principal investigator, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592718
- Sponsor's protocol ID
- 1655312
- Status last verified
- Sep 2021
- First submitted
- 12 Oct 2020
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Four-week Breathing Interventions on Gastrointestinal Symptoms, Heart Rate Variability, and Psychological Measures in Runners
- ClinicalTrials.gov ID
- NCT04592718
- Acronym / sponsor ID
- 1655312
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Slow deep breathing plus breath counting | Experimental | Behavioral: Slow deep breathing plus breath countingParticipants in this group will do a daily 5-min slow deep breathing exercise (6 breaths/minute) and will also count their breaths |
| Normal-paced breathing plus breath counting | Active comparator | Behavioral: Normal-paced breathing plus breath countingParticipants in this group will do a daily 5-min normal-paced breathing (15 breaths/minute) and will also count their breaths |
| Control | No intervention | –Participants in this group will serve as a control and will not do any breathing exercises or breath counting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow deep breathing plus breath countingParticipants 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. | Behavioural | Slow deep breathing plus breath counting |
| Normal-paced breathing plus breath countingParticipants 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. | Behavioural | Normal-paced breathing plus breath counting |
Primary outcome
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).
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Wilson principal investigator
Old Dominion University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow deep breathing plus breath counting and Normal-paced breathing plus breath counting in people with Gastrointestinal System--Abnormalities and Anxiety, run by Old Dominion University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.