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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Chilliwack, British Columbia, Canada, V2R0N3
        • Recruiting
        • University of the Fraser Valley
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Mindful meditation
20 minute, video-based mindful meditation focusing on relaxation.
Behavioral: Mindful meditation
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
Behavioral: Breathwork
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the Fraser Valley

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Les Mills International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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