- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521956
The Effects of a Mindfulness Program on Running Performance, Respiratory Function, and Heart Rate Variability
April 3, 2026 updated by: Gillian Hatfield, University of the Fraser Valley
Broadly, the objective of the research is to evaluate the effectiveness of a specific breathwork program (Les Mills Breath) on various physiological variables related to running performance, compared to a mindfulness control (20 minutes of guided meditation).
There are three specific research questions: 1) Does daily participation in a 20-minute breathwork program improve respiratory function more than a mindfulness control intervention?
2) Does daily participation in a 20-minute breathwork program improve heart rate variability (an indicator of parasympathetic nervous system activity which is associated with enhanced exercise recovery) more than a mindfulness control intervention?
3) Does daily participation in a 20-minute breathwork program increase self-selected running speeds at relative moderate and vigorous intensities more than a mindfulness control intervention?
The intended outcomes of the current research are to contribute to the field of research which has examined various forms of "respiratory training" and their effects on athletic performance, specifically running.
While certain training protocols have been shown to be effective, there are issues of accessibility which persist.
Methods of respiratory training/breathwork which are more easily available to recreational athletes are understudied with regards to running performance, hence the current research.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gillian Hatfield, PhD
- Phone Number: 2217 1 604-504-7441
- Email: gillian.hatfield@ufv.ca
Study Locations
-
-
British Columbia
-
Chilliwack, British Columbia, Canada, V2R0N3
- Recruiting
- University of the Fraser Valley
-
Contact:
- Gillian Hatfield, PhD
- Phone Number: 2217 1 604-504-7441
- Email: gillian.hatfield@ufv.ca
-
Principal Investigator:
- Gillian Hatfield, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Must pass the Get Active Questionnaire to assess physical activity risk
- Must regularly engage in recreational running for between 30 and 520 minutes per week
Exclusion Criteria:
- Running more than 520 minutes per week
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Mindful meditation
20 minute, video-based mindful meditation focusing on relaxation.
|
20-minute, video-based mindful meditation focusing on relaxation
|
|
Experimental: Breathwork
20-minute, video based meditation focusing on breathwork: physiological sigh, cyclic breathing with breath holds, resonant frequency breathing
|
20-minute, video-based meditation focusing on breathwork: physiological sigh, cyclic breathing with breath holds, resonant frequency breathing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preferred running speed at moderate intensity
Time Frame: From baseline to followup (4 weeks later)
|
Following a warmup, the speed on a treadmill will be increased until the participant signals that an exertion level of 12/20 is reached on the Rating of Perceived Exertion (RPE) scale, corresponding to moderate intensity and feeling "somewhat hard".
The participant will run at this intensity for five minutes.
The speed will be blinded to the participant throughout the data collection, encouraging them to rely on physical cues of exertion.
|
From baseline to followup (4 weeks later)
|
|
Preferred running speed at vigorous intensity
Time Frame: From baseline to follow-up (4 weeks after baseline)
|
Following the five minutes running at 12/20 (moderate) intensity, the speed will again be increased until a subjective exertion level of 16/20 (vigorous, and feeling "very hard") is reached.
The subject will continue running at this intensity for 5 minutes.
The running speed at each phase will be noted by the researcher.
|
From baseline to follow-up (4 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waking heart rate variability
Time Frame: Baseline to follow-up (4 weeks after baseline)
|
Participants will use a heart rate monitor (Polar chest strap) and the Elite HRV app to measure waking heart rate variability (RMSDD) for 3 minutes each morning for 6 days after the baseline appointment, and for 6 days leading up to the follow-up appointment.
|
Baseline to follow-up (4 weeks after baseline)
|
|
Forced Vital Capacity
Time Frame: Baseline to follow-up (4 weeks after baseline)
|
Forced Vital Capacity (FVC) is the total amount of air a person can forcibly exhale from their lungs after taking the deepest breath possible.
It is measured using a spirometer.
|
Baseline to follow-up (4 weeks after baseline)
|
|
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: Baseline to follow-up (4 weeks after baseline)
|
FEV1 (Forced Expiratory Volume in 1 second) measures the maximum amount of air you can forcibly exhale in the first second of a breath.
It is measured using spirometry.
|
Baseline to follow-up (4 weeks after baseline)
|
|
Peak Expiratory Flow rate (PEFR)
Time Frame: Baseline to follow-up (4 weeks after baseline)
|
PEFR (Peak Expiratory Flow Rate) measures the maximum speed of air exhaled from the lungs.
It is measured using a spirometer.
|
Baseline to follow-up (4 weeks after baseline)
|
|
Maximum Voluntary Ventilation (MVV)
Time Frame: Baseline to follow-up (4 weeks after baseline)
|
Maximum Voluntary Ventilation (MVV) is a pulmonary function test that measures the maximum volume of air a person can inhale and exhale over 12 seconds, reported in liters per minute (L/min).
It is measured using spirometry.
|
Baseline to follow-up (4 weeks after baseline)
|
|
Recovery heart rate variability
Time Frame: Baseline to follow-up (4 weeks after baseline)
|
This is the heart rate variability (measured using a chest strap and the Elite HRV app) obtained during the last 3 minutes of 10 minutes of quiet lying after the running trials.
|
Baseline to follow-up (4 weeks after baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gillian Hatfield, PhD, University of the Fraser Valley
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
April 3, 2026
First Submitted That Met QC Criteria
April 3, 2026
First Posted (Actual)
April 13, 2026
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified participant data that is used in the results publication will be shared with other researchers on reasonable request.
IPD Sharing Time Frame
Available immediately following publication, and for 7 years after publication.
IPD Sharing Access Criteria
Other researchers can contact the Principal Investigator via email to request deidentified data.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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