Can You Breathe Your Way To Better Health?
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Serum Analysis: C-reactive protein (CRP)
研究概览
简要总结
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.
详细描述
STUDY DESIGN:
This study uses a quasi-randomized control trial design, where N=36 will be randomly assigned into one of three groups. These groups will consist of the HIG (n =12), CHG (n= 12), and COG (n = 12). Each participant will receive an identification number as they enroll into the study and then will be quasi-randomly assigned in a balanced manner (with equal males and females in each group) to one of the three groups by a researcher not directly associated with the study. This person will use the excel randomization procedure. An overview of the study is presented in Figure 1 below. Participants will be randomly assigned into one of the three intervention groups: 1) high intensity group (HIG, n = 12), 2) breathe retention group (CHG, n = 12), 3) control group (COG, n = 12).
Figure 1. Overview of Study Visits
Figure 1: Study Overview This study will consist of three intervention groups denoted as HIG (HIIT group), BRG (breath retention group), and COG (control group). Upon completion of the pre-intervention data collection visits, participants will be placed into one of the three intervention groups using a quasi-randomized order. Researchers overseeing the study ensured all three intervention groups were matched to the best of their ability. A total of four testing visits, 2 pre-intervention and 2 post-interventions. The color coding used for the outline visits above demonstrates the similarities between data collection visits. Similar data collection methods for Visit 1 and Visit 3 will be used, as well as Visit 2 and Visit 4, as outlined above.
PARTICIPANTS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age, 18-50 years
- •Sex, Male and Female
- •Informed Consent, The capability and willingness to give written informed consent to understand the
排除标准
- •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 ≥
- •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.
结局指标
主要结局
Serum Analysis: C-reactive protein (CRP)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- VO2Max(Visit 2 (week 1) 30-45 minutes)
研究者
Laura Stewart
Professor
University of Northern Colorado