CancerNCT06829836
Can You Breathe Your Way To Better Health?
A study testing Hight intensity interval training and Cyclic Hyperventilation with Retention in people with Cancer and Chronic Stress, run by University of Northern Colorado at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Chronic Stress, Autonomic Dysfunction
- What is being tested?
- Hight intensity interval training and Cyclic Hyperventilation with Retention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Northern Colorado, 1610 Gunter Hall, 1828 10th Ave, Greeley, CO 80631
Greeley, Colorado, 80631
About this study
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
- Being tested
- Hight intensity interval training, Cyclic Hyperventilation with Retention
- 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)
- Medical subject headings
- Neoplasms, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hight intensity interval trainingBehavioural
Also called HIIT, SIT, Sprint interval training
Participants assigned to this intervention group will complete 6 supervised HIIT sessions over 2 weeks.
Cyclic Hyperventilation with RetentionBehavioural
Also called CHR
Participants of this intervention group will complete a total of 10 remote guided breathing sessions on Zoom over 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cyclic Hyperventilation with Retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Visit 2 (week 1) and Vist 4 (week 4)
Secondary outcomes (6)
Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
PAR-Q+ utilizes yes or no generalized health questions to screen participants interested in engaging in an exercise program for the need of medical clearance and physician release. The PAR-Q+ has 7 general health questions ranging from Does the participant feel chest pain at rest or during activities of daily living? Individuals who are eligible for this investigation require no further medical clearance before participating in an exercise program and should truthfully answer NO to every question. Participants who answer "Yes" to any questions will be required to answer follow-up questions to determine the need for medical clearance. If medical clearance is suggested, the individual will not be eligible to participate.
Measured: Visit 1 (week 1) 10 minutes
Depression Anxiety and Stress Scale (DASS-21)
The DASS-21 contains 3 subscales assessing Depression, Anxiety, and Stress consisting of 7 questions for each subscale, where a high score of 28+ indicates "Extremely Severe" levels of Depression, a high score of 20+ indicates "Extremely Severe" levels of Anxiety, and a high score of 34+ indicates "Extremely Severe" levels of Stress, while low scores of 0-9 indicates "Normal" levels of Depression, scores of 0-7 indicates "Normal" levels of Anxiety, and scores of 0-14 indicates "Normal" levels of Stress. Raw scores for each subcategory will be recorded and multiplied by 2 to calculate the subcategory score.
Measured: Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each
Pittsburg Sleep Quality Index (PSQI)
Participants will be asked to complete a paper version of the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-question self-reported sleep quality tool divided into 7 subcategories for scoring: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Five additional questions directed to the respondent's roommate or bed partner are not used in the scoring but are utilized for clinical purposes.
Measured: Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each
Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
The WURSS is an illness-specific quality of life measurement designed to assess the impact of the common cold (acute upper respiratory infection). It consists of 21 questions that investigate the perception of sickness, the severity of sickness-related symptoms over the last 24 hours, the extent to which sickness has hindered the ability to think clearly and accomplish daily tasks over the past 24 hours, and the comparison of sickness to the day before.
Measured: Visit 1 (week 1) and Visit 3 (week 4) 10 minutes each
Physical Activity and Sleep Tracking
Heart rate, sleep duration, and steps will be measured and obtained via the WHOOP Strap 4. Measures obtained from the WHOOP strap include continuous heart rate monitoring, sleep cycle, sleep stage, and total step data. The HRV measurement from the WHOOP strap will then be compared to the HRV analysis performed using the standard deviation of the normal-to-normal beat method.
Measured: 4 weeks
VO2Max
Maximal oxygen consumption will be assessed on a cycle ergometer using a TrueOne 2400 Metabolic Measurement System. A Polar Heart Rate Sensor H1 will be outfitted for each participant before starting the assessment. Participants will rest for 5 minutes in a seated position when heart rate, blood pressure, and blood lactate are measured. Next, the participant will be fitted to the cycle ergometer and perform a brief 5-minute warm-up at 0.5 kg and 60 rpm. Next, the pedal cadence increases to 75-85 rpm, and the participant starts stage 1. Every stage lasts 3 minutes, at the end of every stage, heart rate, blood lactate, blood pressure, and RPE are recorded, and 0.5 kg of resistance is added to the weight basket. Once blood lactate concentration is above 4.0 mmol/L, an incremental increase of 0.2 kg occurs. Assessment is terminated after volitional fatigue, failure to maintain pedal cadence, failure to increase heart rate or VO2 in subsequent stages, and the participant's request.
Measured: Visit 2 (week 1) 30-45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start27 Jan 2025
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Northern Colorado
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Stewart, University of Northern Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829836
- Sponsor's protocol ID
- 2404058931
- Status last verified
- Jan 2025
- First submitted
- 11 Feb 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make all study documents available by reasonable request (Laura.stewart@unco.edu) up to 3 years after data collection is complete.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can You Breathe Your Way To Better Health?
- ClinicalTrials.gov ID
- NCT06829836
- Acronym / sponsor ID
- 2404058931
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Northern ColoradoUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Hight intensity interval trainingDuring 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. |
| CHG, Cyclic hyperventilation group | Active comparator | Behavioral: Cyclic Hyperventilation with RetentionThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hight intensity interval trainingAlso: HIIT, SIT, Sprint interval trainingParticipants assigned to this intervention group will complete 6 supervised HIIT sessions over 2 weeks. | Behavioural | HIG, High intensity group |
| Cyclic Hyperventilation with RetentionAlso: CHRParticipants of this intervention group will complete a total of 10 remote guided breathing sessions on Zoom over 2 weeks. | Behavioural | CHG, Cyclic hyperventilation group |
Primary outcome
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.
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.
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.
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.
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.
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).
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.
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.
Heart Rate Variability (HRV)
Time frame: Visit 2 (week 1) and Vist 4 (week 4)
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Yes. We will make all study documents available by reasonable request (Laura.stewart@unco.edu) up to 3 years after data collection is complete.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hight intensity interval training and Cyclic Hyperventilation with Retention in people with Cancer and Chronic Stress, run by University of Northern Colorado at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.