InflammationNCT06395376
Adaptive Stress Response: The Hot Yoga Study
A study testing Bikram Hot Yoga Intervention and Hot Yoga Washout in people with Inflammation and Aging, run by University of Arizona at 1 site in United States.
Trial summary
This is a small intervention study which is aimed at characterizing what is known as the adaptive stress response (also know as "hormesis") in women aged 30-45 years. Participants will perform Bikram Yoga in a room heated to 104°F (40°C) which is often referred to as "Hot Yoga". Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Aging, Depression, Anxiety
- What is being tested?
- Bikram Hot Yoga Intervention and Hot Yoga Washout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2023to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, non-menopausal women between the aged 30 to 45 years (≥30 years and ≤45 years)
- Not pregnant/not planning to get pregnant during the study duration
- Have not previously participated in hot yoga in the last 12-months
- Able to give informed consent and be willing to participate for the entirety of the study
- Agree not to take interfering medications (stated in 'Exclusion Criteria' section below) during the duration of the study
- Agree to allow samples to be stored for future use
Show all 18Show fewer
- Pass the preliminary health screening
- Answer no for every question on the Physical Activity Readiness Questionnaire (PAR-Q ) during preliminary screening
- Exclusion Criteria:1) Menopausal 2) Answered "Yes" to any question on the Physical Activity Readiness Questionnaire (PAR-Q) 3) Currently lactating 4) Currently pregnant or plan to get pregnant within the duration of the study 5) Has participated in hot yoga within the last 12-months 6) Used tobacco products (smoked, smokeless, electronic) within the last six months 7) Have diabetes, cancer, heart attack or vascular surgery within the past year, be diagnosed with heart disease, high blood pressure, history of stroke, atherosclerosis, asthma, multiple sclerosis or chronic joint disease 8) Have gallbladder disease or had gallbladder removed 9) Have any of the following health conditions:
- fasting Triglycerides greater than 150 milligrams/deciliter
- Blood pressure greater than 130/90
- Body Mass Index equal to or greater than 30 or less than 19
- Fasting glucose greater than 125 milligrams/deciliter.
- Having a pacemaker or a defibrillator 10) Taking any of the following drugs:
- Taking greater than 100 mg aspirin/day
- Taking non-steroidal anti-inflammatory drugs or oral corticosteroids
- Taking monteleukast-type of allergy medications
- Use of statins, niacin or fibrates or other lipid lowering medications
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Networks Involved in the Adaptive Stress Response: The Hot Yoga Study
This is a small intervention study which is aimed at characterizing what is known as the adaptive stress response (also know as "hormesis") in women aged 30-45 years. Participants will perform Bikram Yoga in a room heated to 104°F (40°C) which is often referred to as "Hot Yoga".
The hypothesis of this study is that a protective and health-promoting adaptive stress response can be induced in living humans by performing exercise in a hot environment. The primary question is:How does the body physiologically adapt to performing moderately vigorous exercise in a hot environment?
Read the detailed description
This is a small scale intervention pilot study which is aimed at characterizing "hormesis" or the "adaptive stress response" in a small cadre (n = 28) of women aged 30-45 years performing moderately vigorous physical activity, Bikram Yoga, in a hot environment, simply referred to as "Hot Yoga". The primary question is:How does the body physiologically adapt to performing moderately vigorous exercise in a hot environment?
The hypothesis of this study which underlies the primary question is that a protective and health-promoting adaptive stress response can be induced in living humans through exposure to mild heat stress and moderately vigorous physical exercise while practicing hot yoga. The central premise is that a combination of environmental stressors during each hot yoga session will induce changes in molecular networks and metabolism that will enhance physical/mental health and physiological resilience.
Primary, secondary and tertiary study endpoints:
Characterize the physiological changes brought on by the adaptive stress response using an "omics" approach. Lipidomics and metabolomics will be used to identify changes in small molecule species found in circulating plasma that are associated with the physiological changes the investigators anticipate will occur with the adaptive stress response.
Characterize the adaptive stress response by measuring the changes in the inflammatory response using common inflammation biomarkers: C-reactive protein (CRP), Tumor Necrosis Factor Alpha (TNF-alpha), and Interleukin-6 (IL-6). A complete blood count (CBC) w/Differential assay will also be performed at baseline and after the last Hot Yoga practice to assess any changes in blood components (red blood cells [RBC], white blood cells [WBC], platelets, etc.) that may have occurred in response to the intervention. In addition, the investigators will use buffy coat to assay all WBCs and will perform both typing and counting of WBCs to assess changes relevant to the adaptive stress response. Finally, buffy coat will be used for DNA isolation to genotype for single nucleotide polymorphisms (SNPs) that are related to the adaptive stress response.
Characterize the acute effect that exercising in a hot environment has on emotional stress and well-being using:
Positive and Negative Affect Schedule - Short Form (PANAS-SF) PROMIS - Global Health Scale
Assess long-term effects of the intervention on emotional stress and well-being using a battery of questionnaires that include Warwick-Edinburgh Mental Well-being Scale (WEMWBS) Patient Health Questionnaire (PHQ-9) Generalized Anxiety Disorder (GAD-7) Perceived Stress Scale (PSS)
Importantly, circulating levels of small molecule metabolites will be determined with metabolomic and lipidomic analyses utilizing HPLC-tandem mass spectrometry. Levels of blood inflammatory and stress biomarkers interleukin-6 (IL-6), Tumor Necrosis Factor Alpha (TNF-α), and C-reactive protein (CRP) will be measured utilizing standard enzyme linked immunosorbent assays (ELISA). These assays may be performed in-house or at Sonora Quest Laboratories.
The investigators will implement the use of biostatistics, bioinformatics, and other statistical methods to analyze, interpret, and express the found data and dependent upon the findings, then use the data as the base for grant funding to conduct a full scale clinical trial testing the aforementioned hypotheses.
- Conditions
- Inflammation, Aging, Depression, Anxiety
- Being tested
- Bikram Hot Yoga Intervention, Hot Yoga Washout
- Keywords
- Yoga, Hyperthermia, Inflammation, Exercise
- Medical subject headings
- Inflammation, Depression, Anxiety Disorders, Hyperthermia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bikram Hot Yoga InterventionOther
Active participants engage in a yoga intervention which entails participating in a minimum of 60-minutes of hot yoga (Bikram sequence), 3x per week in a heated room at 40 degrees C. The intervention will be 6-weeks of active intervention when they are participating in yoga, followed by an 6-week "washout" period where they will be asked to not practice yoga. Participants will be asked to give blood at 9 timepoints throughout the 12-week study, including baseline, week one, midpoint, end of Hot Yoga Intervention (Week 6) and after Washout (Week 12)
Hot Yoga WashoutOther
The "Washout" period consists of 6-weeks occurring immediately after the Hot Yoga Intervention during which the participants do not perform any hot yoga.
| Study group | Role | What they receive |
|---|---|---|
| Hot Yoga Intervention | Experimental | Bikram Hot Yoga intervention: Participants perform a minimum of 60-minutes of Hot Yoga (Bikram Sequence), 3x per week in a heated room (40 degrees C) for 6-weeks Receives: Other: Bikram Hot Yoga Intervention |
| Hot Yoga Washout | Other | Hot Yoga Washout: Participants complete a 6-week "Washout" period during which the participants performed no Hot Yoga. Receives: Other: Hot Yoga Washout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory biomarkers
cytokines and hsCRP
Measured: Assessed at baseline, Intervention week1, intervention midpoint (3 weeks), end of intervention (Week 6). end of study (Week 12; after washout)
Blood Lipids
Lipid panel (milligrams per deciliter, mg/dL)
Measured: Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Hemoglobin A1C
Comprehensive Metabolic Panel (millimole per mole, mmol/mol)
Measured: Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Fasting glucose/insulin
Comprehensive Metabolic Panel (milligrams per deciliter, mg/dL)
Measured: Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Immune cell phenotypes
Percent Immune phenotypes
Measured: Measured at the Start of Intervention (Week1), intervention midpoint (Week 3), end of intervention (Week 6), and end of study (Week 12; after washout)
Secondary outcomes (6)
Positive and Negative Affect Schedule (PANAS) (Measures Positive and Negative Mood)
The Positive and Negative Affect Schedule (PANAS) questionnaire used as a self-report measure of mood and is made up of two mood scales, one measuring positive affect and the other measuring negative affect. The questionnaire consists of 20 items and uses a likert scale of "1" to "5" to measure responses of "1" (Very slightly or not at all), "2" (A little), "3" (Moderately), "4" (Quite a bit), and "5" (Extremely)
Measured: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
PROMIS (Patient Reported Outcomes Measurement Information System) - Global Health Scale (Measures well-being)
PROMIS is a system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. This instrument uses a "reverse" Likert scale of "5" to "1" to measure responses of "5" (Excellent), "4" (Very good), "3" (Good), "2" (Fair), and "1" (Poor) to measure responses to 10 items.
Measured: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Measures well-being)
Warwick-Edinburgh Mental Well-being Scale (WEMWBS) measures subjective well-being and assesses aspects of well-being that are "conducive to happiness or eudemonic" and "sensually self-indulgent or hedonistic". This instrument has 14 items and uses a Likert scale of "1" to "5" to measure responses: "1" (None of the time), "2" (Rarely), "3" (Some of the time), "4" (Often), and "5" (All of the time)
Measured: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Patient Health Questionnaire (PHQ-9) (Measures depression)
Patient Health Questionnaire (PHQ-9) is a multipurpose instrument that has two questions (the first is split into 9 "subsections") and is used for screening, diagnosing, monitoring and measuring the severity of depression. A scale of "0-3" is assigned to the four boxes. These numbers represent an individual value for each item (depending on which box is checked) that, when summed, provides a "total score" that is representative of a level of depression.
Measured: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Generalized Anxiety Disorder (GAD-7)
Generalized Anxiety Disorder (GAD-7) consists of seven items used to measure worry and anxiety symptoms using a "0" to "3" Likert scale to score responses to "how often": "0" (Not at all sure), "1" (Several Days), "2" (Over half the days), "3" (Nearly every day).
Measured: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS) uses ten questions to measure the degree to which situations in one's life are appraised/perceived as stressful. This instrument uses a Likert scale of "0" to "4": "0" (Never), "1" (Almost never), "2" (Sometimes), "3" (Fairly Often), "4" (Very Often).
Measured: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start11 Feb 2023
- Primary completion13 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Floyd Chilton, University of Arizona
- Investigators
- Floyd Chilton, Ph.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395376
- Sponsor's protocol ID
- IRB1911122754
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Networks Involved in the Adaptive Stress Response: The Hot Yoga Study
- ClinicalTrials.gov ID
- NCT06395376
- Acronym / sponsor ID
- IRB1911122754
- Conditions
- Inflammation, Aging, Depression, Anxiety
- Keywords
- Yoga, Hyperthermia, Inflammation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 11 Feb 2023 (actual)
- Primary completion
- 13 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 2 May 2024 (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.
This is a small intervention study which is aimed at characterizing what is known as the adaptive stress response (also know as "hormesis") in women aged 30-45 years. Participants will perform Bikram Yoga in a room heated to 104°F (40°C) which is often referred to as "Hot Yoga".
The hypothesis of this study is that a protective and health-promoting adaptive stress response can be induced in living humans by performing exercise in a hot environment. The primary question is:How does the body physiologically adapt to performing moderately vigorous exercise in a hot environment?
Detailed description
This is a small scale intervention pilot study which is aimed at characterizing "hormesis" or the "adaptive stress response" in a small cadre (n = 28) of women aged 30-45 years performing moderately vigorous physical activity, Bikram Yoga, in a hot environment, simply referred to as "Hot Yoga". The primary question is:How does the body physiologically adapt to performing moderately vigorous exercise in a hot environment?
The hypothesis of this study which underlies the primary question is that a protective and health-promoting adaptive stress response can be induced in living humans through exposure to mild heat stress and moderately vigorous physical exercise while practicing hot yoga. The central premise is that a combination of environmental stressors during each hot yoga session will induce changes in molecular networks and metabolism that will enhance physical/mental health and physiological resilience.
Primary, secondary and tertiary study endpoints:
Characterize the physiological changes brought on by the adaptive stress response using an "omics" approach. Lipidomics and metabolomics will be used to identify changes in small molecule species found in circulating plasma that are associated with the physiological changes the investigators anticipate will occur with the adaptive stress response.
Characterize the adaptive stress response by measuring the changes in the inflammatory response using common inflammation biomarkers: C-reactive protein (CRP), Tumor Necrosis Factor Alpha (TNF-alpha), and Interleukin-6 (IL-6). A complete blood count (CBC) w/Differential assay will also be performed at baseline and after the last Hot Yoga practice to assess any changes in blood components (red blood cells [RBC], white blood cells [WBC], platelets, etc.) that may have occurred in response to the intervention. In addition, the investigators will use buffy coat to assay all WBCs and will perform both typing and counting of WBCs to assess changes relevant to the adaptive stress response. Finally, buffy coat will be used for DNA isolation to genotype for single nucleotide polymorphisms (SNPs) that are related to the adaptive stress response.
Characterize the acute effect that exercising in a hot environment has on emotional stress and well-being using:
Positive and Negative Affect Schedule - Short Form (PANAS-SF) PROMIS - Global Health Scale
Assess long-term effects of the intervention on emotional stress and well-being using a battery of questionnaires that include Warwick-Edinburgh Mental Well-being Scale (WEMWBS) Patient Health Questionnaire (PHQ-9) Generalized Anxiety Disorder (GAD-7) Perceived Stress Scale (PSS)
Importantly, circulating levels of small molecule metabolites will be determined with metabolomic and lipidomic analyses utilizing HPLC-tandem mass spectrometry. Levels of blood inflammatory and stress biomarkers interleukin-6 (IL-6), Tumor Necrosis Factor Alpha (TNF-α), and C-reactive protein (CRP) will be measured utilizing standard enzyme linked immunosorbent assays (ELISA). These assays may be performed in-house or at Sonora Quest Laboratories.
The investigators will implement the use of biostatistics, bioinformatics, and other statistical methods to analyze, interpret, and express the found data and dependent upon the findings, then use the data as the base for grant funding to conduct a full scale clinical trial testing the aforementioned hypotheses.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot Yoga Intervention | Experimental | Other: Bikram Hot Yoga InterventionBikram Hot Yoga intervention: Participants perform a minimum of 60-minutes of Hot Yoga (Bikram Sequence), 3x per week in a heated room (40 degrees C) for 6-weeks |
| Hot Yoga Washout | Other | Other: Hot Yoga WashoutHot Yoga Washout: Participants complete a 6-week "Washout" period during which the participants performed no Hot Yoga. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Healthy, non-menopausal women between the aged 30 to 45 years (≥30 years and ≤45 years)
- Not pregnant/not planning to get pregnant during the study duration
- Have not previously participated in hot yoga in the last 12-months
- Able to give informed consent and be willing to participate for the entirety of the study
- Agree not to take interfering medications (stated in 'Exclusion Criteria' section below) during the duration of the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bikram Hot Yoga InterventionActive participants engage in a yoga intervention which entails participating in a minimum of 60-minutes of hot yoga (Bikram sequence), 3x per week in a heated room at 40 degrees C. The intervention will be 6-weeks of active intervention when they are participating in yoga, followed by an 6-week "washout" period where they will be asked to not practice yoga. Participants will be asked to give blood at 9 timepoints throughout the 12-week study, including baseline, week one, midpoint, end of Hot Yoga Intervention (Week 6) and after Washout (Week 12) | Other | Hot Yoga Intervention |
| Hot Yoga WashoutThe "Washout" period consists of 6-weeks occurring immediately after the Hot Yoga Intervention during which the participants do not perform any hot yoga. | Other | Hot Yoga Washout |
Primary outcome
Inflammatory biomarkers
Time frame: Assessed at baseline, Intervention week1, intervention midpoint (3 weeks), end of intervention (Week 6). end of study (Week 12; after washout)
cytokines and hsCRP
Blood Lipids
Time frame: Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Lipid panel (milligrams per deciliter, mg/dL)
Hemoglobin A1C
Time frame: Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Comprehensive Metabolic Panel (millimole per mole, mmol/mol)
Fasting glucose/insulin
Time frame: Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Comprehensive Metabolic Panel (milligrams per deciliter, mg/dL)
Immune cell phenotypes
Time frame: Measured at the Start of Intervention (Week1), intervention midpoint (Week 3), end of intervention (Week 6), and end of study (Week 12; after washout)
Percent Immune phenotypes
6 secondary outcomes
Positive and Negative Affect Schedule (PANAS) (Measures Positive and Negative Mood)
Time frame: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
PROMIS (Patient Reported Outcomes Measurement Information System) - Global Health Scale (Measures well-being)
Time frame: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Measures well-being)
Time frame: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Patient Health Questionnaire (PHQ-9) (Measures depression)
Time frame: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Generalized Anxiety Disorder (GAD-7)
Time frame: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Perceived Stress Scale (PSS)
Time frame: Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Floyd Chilton, Ph.D. principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bikram Hot Yoga Intervention and Hot Yoga Washout in people with Inflammation and Aging, run by University of Arizona 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 18 inclusion and 0 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: finished, as of the sponsor's last update on 2 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inflammatory biomarkers (time frame: Assessed at baseline, Intervention week1, intervention midpoint (3 weeks), end of intervention (Week 6). end of study (Week 12; after washout)). 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 2 May 2024.