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Enrolling by invitation NCT06829836

Can You Breathe Your Way To Better Health?

No phase Interventional Cancer Chronic Stress Autonomic Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hight intensity interval training, Cyclic Hyperventilation with Retention.
Who it may be relevant to
Registry conditions: Cancer, Chronic Stress, Autonomic Dysfunction. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Hight intensity interval training
    Participants assigned to this intervention group will complete 6 supervised HIIT sessions over 2 weeks.
  • Behavioral Cyclic Hyperventilation with Retention
    Participants of this intervention group will complete a total of 10 remote guided breathing sessions on Zoom over 2 weeks.

Primary outcome measures

  • Serum Analysis: C-reactive protein (CRP) [Time frame: Visit 1(Week 1) and Visit 3 (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours.]
  • Serum Analysis: Brain Derived Neurotrophic Factor (BDNF) [Time frame: Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours.]
  • Natural Killer cell quantity [Time frame: Visit 1(Week 1) and Visit 3 (Week 4): 15 minutes for blood draw. The assay itself takes ~10-12 hours.]
  • Natural Killer Cell Cytotoxicity [Time frame: Visit 1(Week 1) and Visit 3 (Week 4): 15 minutes for blood draw. The assay itself takes ~10-12 hours.]
  • Heart Rate Variability (HRV) [Time frame: Visit 2 (week 1) and Vist 4 (week 4)]
Secondary outcome measures (6)
  • Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) [Time frame: Visit 1 (week 1) 10 minutes]
  • Depression Anxiety and Stress Scale (DASS-21) [Time frame: Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each]
  • Pittsburg Sleep Quality Index (PSQI) [Time frame: Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each]
  • Wisconsin Upper Respiratory Symptom Survey (WURSS-21) [Time frame: Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each]
  • Physical Activity and Sleep Tracking [Time frame: 4 weeks]
  • VO2Max [Time frame: Visit 2 (week 1) 30-45 minutes]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Northern Colorado, 1610 Gunter Hall, 1828 10th Ave, Greeley, CO 80631 — Greeley

Identifiers

NCT: NCT06829836 · 2404058931

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗