Can You Breathe Your Way To Better Health?

NCT06829836 | Enrolling By Invitation

• 1 other identifier: 2404058931
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (5)

• Serum Analysis: C-reactive protein (CRP)

  Approximately 60 mL of whole blood will be collected into serum separator tubes (Beckton Dickinson, East Rutherford, NJ, USA), allowed to clot for 30-min at room temperature, and then centrifuged at 2000 RPM for 15 min. The serum will be pipetted into 1.5 mL microcentrifuge tubes (Eppendorf AG, Hamburg, Germany) and immediately stored in a -80 °C freezer. Serum concentrations of CRP will be determined with a commercially available enzyme-linked immunosorbent assay (ALPCO Diagnostics, Salem, NH, USA). Microplates will be read with an ELx800 BioTek microplate reader (BioTek Instruments, Inc., Winooski, VT, USA) at the recommended wavelength of 450 nanometers.

  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)

  Approximately 40 mL of whole blood will be collected into serum separator tubes (Beckton Dickinson, East Rutherford, NJ, USA), allowed to clot for 30 minutes at room temperature, and then centrifuged at 2000 RPM for 15 min. The serum will be pipetted into 1.5 mL microcentrifuge tubes (Eppendorf AG, Hamburg, Germany) and immediately stored in a -80 °C freezer. Serum concentrations of BDNF (Sigma-Aldrich, St. Louis, MO, USA) will be determined with commercially available enzyme-linked immunosorbent assays. Microplates will be read with an ELx800 BioTek microplate reader (BioTek Instruments, Inc., Winooski, VT, USA) at the recommended wavelength of 450 nanometers.

  Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours.

• Natural Killer cell quantity

  15mL of whole blood will be obtained using sodium heparin tubes and a peripheral venous puncture. Blood samples will be mixed with Dulbecco's phosphate buffer solution (DPBS) at a 1:1 ratio and layered over 20 mL of Ficoll gradient matrix. Blood samples will be centrifugation at 111 x g for 40 minutes, acceleration 7, brake 0 (Eppendorf 5810R centrifuge, Hamburg, Germany). Samples will be washed 3 times, then resuspended at 1.0 \* 10\^6 cells/mL and incubated for 4 hours at 37 degrees Celsius, with 5% CO2. Next, samples will be pelleted, resuspended, and antibody-receiving samples will each receive 500uL DPBS and 1uL of Fragment crystabillize blocker (FcB)/1.0\*10\^6 cells and incubate on ice for 20 minutes. Samples will be pelleted, resuspended in 500uL DPBS and receive 500uL of DPBS and 2uL of CD56 (NCAM) monoclonal antibodies, incubate on ice for 20 minutes, pelleted, and resuspended in 1mL of DPBS, then analyzed using an Attune NXT flow cytometer (Thermo Fischer, Waltham, MA).

  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

  Chronic human myelogenous leukemia cells (K562; ATCC, Manassas, VA) are used to evaluate NKC effector function. K562 cells are stained with Alexa-Fluor 647-conjugated anti-CD71. K562 cells are further stained with Calcein-AM viability dye (Thermo Fisher Scientific, Waltham, MA), then incubated on ice for 20 min. K562 cells are washed and resuspended at 1.0 × 106 cells/mL in complete RPMI 1640 medium. Human PBMCs containing effector NK and NKT cells are co-cultured with K562 cells in 5 mL Eppendorf tubes at a 40:1 PBMC: K562 effector: target (E: T) ratio and incubated for 4 h at 37 °C in a cell incubator. Following co-incubation, samples are centrifuged at 400 x g for 5 min and resuspended in ice-cold DPBS for analysis. After the 4-hour co-culture, these samples are analyzed via flow cytometry to determine the total proportion of alive (Calcein-AM+/CD71+) versus estimated K562 cells. Changes in proportion and MFI of these populations were further analyzed using Floreada.io.

  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)

  Heart rate variability (HRV) will be analyzed to determine the fluctuation in the time intervals between adjacent heartbeats to assess autonomic regulation of the heart. Resting HR and HRV were measured using the electrocardiograph (GE CASE Exercise Testing System Version 6.0, Chicago, Illinois). To measure HRV, the standard deviation of normal to normal beats (SDNN) was used with the 10-second electrocardiogram reading. Based on the outcome of this assessment, participants with SDNN values below 50 ms will be classified as unhealthy, 50-100 ms will be classified as having compromised health, and above 100 ms will be classified as healthy.

  Visit 2 (week 1) and Vist 4 (week 4)

Secondary Outcomes (6)

• Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)

  Visit 1 (week 1) 10 minutes

• Depression Anxiety and Stress Scale (DASS-21)

  Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each

• Pittsburg Sleep Quality Index (PSQI)

  Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each

• Wisconsin Upper Respiratory Symptom Survey (WURSS-21)

  Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each

• Physical Activity and Sleep Tracking

  4 weeks

Other Outcomes (5)

• Anthropometric Measures: Height

  Visit 1 (week 1)

• Anthropometric Measures: Weight

  Visit 1 (week 1)

• Anthropometric Measures: Lean Body Mass

  Visit 1 (week 1)

Study Arms (3)

CON, control

NO INTERVENTION

The control group will undergo the same testing procedures outlined above, but they will be asked to maintain their current level of activity and normal daily habits for the duration of the intervention.

HIG, High intensity group

ACTIVE COMPARATOR

During the exercise session, HR will be measured via a Polar heart rate strap (Kempele, Finland). The training sessions will consist of six 90-second high-intensity cycling (HIC) sprints performed on a cycle ergometer (Monark Ergomedic 895E, Monark, Varberg, Sweden) at 80-90% VO2max, followed by 180 seconds of low-intensity cycling (LIC) at 50-60% of VO2max. During both HIC and LIC intensities, participants will be asked rate of perceived exertion, which will be compared to the participants' heart rate throughout the exercise sessions. This supervised training protocol will require 9 minutes of HIC at 80-90% VO2max and 18 minutes of LIC at 50-60% VO2max. The cycling session will begin with a brief warm-up and end with a cool-down down totaling the entire supervised exercise session for 30 minutes. Training sessions will be performed 48 hours after the previous training session for a total of 3 times per week on Mondays, Wednesdays, and Fridays.

Behavioral: Hight intensity interval training

CHG, Cyclic hyperventilation group

ACTIVE COMPARATOR

The breathing intervention will consist of a daily breathing practice lasting 5 to 10 minutes for 5 days per week. Breathing practice is a form of cyclic hyperventilation consisting of 30 breath (inhalation and exhalation) repetitions followed by an exhaled breath retention for 15 seconds during the first week and up to 30 seconds during the second week. A total of 3 rounds will be performed by the participants. Participants will be instructed to perform breathing repetitions in a controlled and consistent manner while either seated or lying down. Participants will receive guided instruction via a video on breath cycle queues, informing the participants when to inhale, exhale, and when to retain their breath while being supervised by the research team via Zoom call. Upon completion of the breath training sessions, the research team will conduct a guided cooldown and check in with all participants to ensure they are feeling no adverse side effects from the breathing exercise.

Behavioral: Cyclic Hyperventilation with Retention

Interventions

Hight intensity interval training BEHAVIORAL

Participants assigned to this intervention group will complete 6 supervised HIIT sessions over 2 weeks.

Also known as: HIIT, SIT, Sprint interval training

HIG, High intensity group

Cyclic Hyperventilation with Retention BEHAVIORAL

Participants of this intervention group will complete a total of 10 remote guided breathing sessions on Zoom over 2 weeks.

Also known as: CHR

CHG, Cyclic hyperventilation group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age, 18-50 years
• Sex, Male and Female

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Northern Colorado: lead

Study Sites (1)

University of Northern Colorado, 1610 Gunter Hall, 1828 10th Ave, Greeley, CO 80631

Greeley, Colorado, 80631, United States

Location

MeSH Terms

Conditions

Neoplasms; Primary Dysautonomias

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: January 27, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Start: Jan 27, 2025 - Jan 27, 2028
• Access Criteria: Anyone who contacts Laura.stewart@unco.edu with a reasonable request.

Locations

US (1)