NCT07521956

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 19, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

April 3, 2026

Last Update Submit

April 3, 2026

Conditions

Keywords

respiratory functionrunning performanceheart rate variabilitymindfulnessbreathworkmeditation

Outcome Measures

Primary Outcomes (2)

  • Preferred running speed at moderate intensity

    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

    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 Outcomes (6)

  • Waking heart rate variability

    Baseline to follow-up (4 weeks after baseline)

  • Forced Vital Capacity

    Baseline to follow-up (4 weeks after baseline)

  • Forced Expiratory Volume in 1 second (FEV1)

    Baseline to follow-up (4 weeks after baseline)

  • Peak Expiratory Flow rate (PEFR)

    Baseline to follow-up (4 weeks after baseline)

  • Maximum Voluntary Ventilation (MVV)

    Baseline to follow-up (4 weeks after baseline)

  • +1 more secondary outcomes

Study Arms (2)

Mindful meditation

ACTIVE COMPARATOR

20 minute, video-based mindful meditation focusing on relaxation.

Behavioral: Mindful meditation

Breathwork

EXPERIMENTAL

20-minute, video based meditation focusing on breathwork: physiological sigh, cyclic breathing with breath holds, resonant frequency breathing

Behavioral: Breathwork

Interventions

20-minute, video-based mindful meditation focusing on relaxation

Mindful meditation
BreathworkBEHAVIORAL

20-minute, video-based meditation focusing on breathwork: physiological sigh, cyclic breathing with breath holds, resonant frequency breathing

Breathwork

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Running more than 520 minutes per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Fraser Valley

Chilliwack, British Columbia, V2R0N3, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gillian Hatfield, PhD

    University of the Fraser Valley

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gillian Hatfield, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 13, 2026

Study Start

January 19, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Deidentified participant data that is used in the results publication will be shared with other researchers on reasonable request.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Available immediately following publication, and for 7 years after publication.
Access Criteria
Other researchers can contact the Principal Investigator via email to request deidentified data.

Locations