Clinical trial NCT06829836: Can You Breathe Your Way To Better Health?
Official title: Can You Breathe Your Way To Better Health?
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Chronic Stress
Autonomic Dysfunction
Keywords: High intensity interval training (HIIT)
Cyclic hyperventilation with retention (CHR)
intervention
Natural killer cells
training
stress
autonomic nervous system
innate immune system
natural killer cell cytotoxicity
heart rate variability (HRV)
Lead sponsor: University of Northern Colorado
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this clinical trial is to explore the effects of either a 2-week high-intensity interval training (HIIT) or breath training intervention on measures of overall health, circulating biomarkers of stress, and immune function.

Specific aims include: - Does a 2-week HIIT or breath training intervention improve measurements of overall health, including heart rate variability, physical activity, sleep quality, and severity of depression, anxiety, and stress? -Does a 2-week HIIT or breath training intervention improve circulating concentrations of stress-related biomarkers? Does a 2-week HIIT or breath training intervention improve immune function? Researchers will compare HIIT and breath training to see if equivalent immune improvements are observed.

Participants will: -Undergo 2 weeks of HIIT or breath training interventions at a frequency of 3 times per week for 30 minutes or 5 times per week for 5 minutes if placed into an intervention group. -Undergo testing measures at the two pre- and post-intervention time points, if placed in the intervention groups or the healthy control group.


Eligibility criteria: Inclusion Criteria:

* Age, 18-50 years
* Sex, Male and Female
* Informed Consent, The capability and willingness to give written informed consent to understand the exclusion criteria and to accept the randomized group assignment is required.
* PAR-Q+, The capability and willingness to complete the physical activity readiness questionnaire, with no medical clearance needed.
* Physical Activity: Participants must refrain from regular HIIT and structured breathing practices for a month before participation
* Depression, Anxiety, and Stress Scale, Subcategory Scoring (DASS-21) Participants must score in the mild or greater category for Depression, Anxiety, and Stress. Depression ≥ 10, Anxiety ≥ 8, and Stress ≥ 14.

Exclusion Criteria:

* Age: Individuals under 18 years and over 50 years
* Significant Respiratory Conditions, including but not limited to asthma, chronic obstructive pulmonary disease,
* Significant Cardiovascular Disease: Participants with a known cardiovascular condition such as a previous myocardial infarction, congestive heart failure, stroke, or transient ischemic attack, cardiomyopathy, serious arrhythmia, peripheral vascular disease, untreated atherosclerosis, or hypertension.
* Significant Musculoskeletal Disease, including but not limited to osteopenia, osteoporosis, rheumatoid arthritis, and sarcopenia
* Cognitive and Mental Health, including but not limited to untreated anxiety, untreated depression, post-traumatic stress disorder, and thoughts of suicide.

Primary outcomes:
measure: Serum Analysis: C-reactive protein (CRP)
timeFrame: Visit 1(Week 1) and Visit 3 (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours.
measure: Serum Analysis: Brain Derived Neurotrophic Factor (BDNF)
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours.
measure: Natural Killer cell quantity
timeFrame: Visit 1(Week 1) and Visit 3 (Week 4): 15 minutes for blood draw. The assay itself takes ~10-12 hours.
measure: Natural Killer Cell Cytotoxicity
timeFrame: Visit 1(Week 1) and Visit 3 (Week 4): 15 minutes for blood draw. The assay itself takes ~10-12 hours.
measure: Heart Rate Variability (HRV)
timeFrame: Visit 2 (week 1) and Vist 4 (week 4)
Secondary outcomes:
measure: Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
timeFrame: Visit 1 (week 1) 10 minutes
measure: Depression Anxiety and Stress Scale (DASS-21)
timeFrame: Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each
measure: Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
timeFrame: Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each
measure: Physical Activity and Sleep Tracking
timeFrame: 4 weeks
measure: VO2Max
timeFrame: Visit 2 (week 1) 30-45 minutes
Other outcomes:
measure: Anthropometric Measures: Height
timeFrame: Visit 1 (week 1)
measure: Anthropometric Measures: Weight
timeFrame: Visit 1 (week 1)
measure: Anthropometric Measures: Lean Body Mass
timeFrame: Visit 1 (week 1)
measure: Anthropometric Measures: Body Fat Percentage
timeFrame: Visit 1 (week 1)
measure: Hydration
timeFrame: Visit 1, Visit 2 (week 1) and Visit 3 (Week 4)
Locations:
city: Greeley
country: United States
facility: University of Northern Colorado, 1610 Gunter Hall, 1828 10th Ave, Greeley, CO 80631
state: Colorado
Study officials:
References: