InflammationNCT04444102
The Acute Impact of Yoga-based Stretching on Inflammation and Its Resolution
A study testing Yoga-based stretching in people with Inflammation and Fascia; Inflammation, run by Harvard University Faculty of Medicine at 1 site in United States.
Trial summary
The goal of this study is to explore the impact of two types of yoga-based body stretching (mild and intense) on dynamic changes of Systemic Inflammatory Cytokines (SICs) and Specialized Pro-resolving Mediators (SPMs) in yoga-naïve subjects. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Fascia; Inflammation, Musculoskeletal Pain
- What is being tested?
- Yoga-based stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 30 Sep 2024
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- Age between 40 - 60 years old.
- Non-smoking
- BMI between 19 and 29.
Who cannot join
- Any history of chronic inflammatory disease or recent acute illness (< 1 month)
- Vaccination within the last 3 months
- Regular medication, or any medication in the preceding week
- Practice of structured higher-intensity exercise at least twice a week for more than 30 minutes
- Pregnancy
- Endocrine disorders (e.g. diabetes)
Show all 11Show fewer
- Significant soft tissue injury
- Surgical supportive devices (nails, wire, screws, pins, plates) in an area of the body to be stretched (toes, ankles, knees, hips, shoulders, elbows, wrists, fingers and spine)
- Fractures in the past 3 years
- Generalized joint hypermobility or genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome
- Alcoholism (> 10 drinks per week) and drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ambulatory Clinical Center (ACC)
Boston, Massachusetts, 02115
About this study
Official title: The Acute Impact of Yoga-based Stretching on Inflammation and Its Resolution: a Pilot Study
The goal of this study is to explore the impact of two types of yoga-based body stretching (mild and intense) on dynamic changes of Systemic Inflammatory Cytokines (SICs) and Specialized Pro-resolving Mediators (SPMs) in yoga-naïve subjects.
Read the detailed description
During the last decade, yoga has become increasingly popular in Western cultures. The 2017 NIH report indicated that 14.3% of the adult population practice yoga in the USA. The most common yoga styles tested in randomized clinical trials (RCTs) are Hatha, Iyengar, and Patanjali.
One key physical component of yoga is the stretching that occurs during different postures. Based on animal studies, it is plausible to think that the physical intensity of stretching may affect systemic inflammatory outcomes, i.e. SICs and SPMs. However, human studies have not isolated and quantified the impact of stretching. In consequence, it is not known to what extent the benefits of yoga can be attributed to the physical aspect of stretching. One way to explore the effect of yoga would be to isolate the stretching element and compare two stretching protocols with yoga-based postures on SICs and SPMs.
In previous preclinical studies using an ex-vivo stretching model of mouse connective tissue (AICUC: 04996), the investigators found that fibroblasts are actively involved in the regulation of connective tissue tension, demonstrating that fibroblasts have a more elaborate scheme of responses to mechanical stress than was previously thought.
Later, in the inflammatory active stretch rat model (AICUC 04995), the investigators found that after 10 minutes of an active stretch there was a significant reduction in the inflammatory lesion size area measured with ultrasound and a reduction of infiltrating neutrophils. The SPM Resolvin 1 (RvD1) was also measured and showed a significant difference between the stretch and no stretch group. These promising results encouraged the investigators to keep exploring the fundamental innate mechanism by which the body enhances the healing of an inflammatory process regardless of its etiology; e.g., a mouse breast cancer model with active stretch showed that with four weeks of stretching once a day, tumors were reduced roughly to the half comparing with the no-stretch group and a pig study currently underway is exploring the effects of active stretching on SPMs production and determining changes in Polymorphonuclear Neutrophil (PMN) and macrophages migration toward the inflammatory stimulus.
These pre-clinical results motivated the research group to move forward with a translational pilot study to explore first the feasibility and second, the effect of stretching on the connective tissue and muscles of healthy humans. The investigators presume to find an effect of stretching on a systemic level. Hence, they propose to measure levels of SICs and SPMs, as well as their changes over time after one acute session of yoga-based stretching postures. The investigators plan to collect blood samples at baseline pre-intervention and then at 0 minutes, 30 minutes, 1, 2, and 3, and 24 hours after the intervention. Samples will be analyzed using flow cytometry and ELISA.
- Being tested
- Yoga-based stretching
- Keywords
- stretching, yoga, mind-body therapies, inflammation
- Medical subject headings
- Inflammation, Fasciitis, Musculoskeletal Pain, Low Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga-based stretchingProcedure or surgery
Different yoga postures (ASANA) were isolated from conventional yoga practice to stretch different muscle groups.
Muscle groups stretched: hip extensor and adductors, hip \& plantar flexors, shoulder extensors, shoulder horizontal adductors, shoulder extensors-adductor, wrist flexor, trunk extensors, lateral flexors, and trunk rotators.
| Study group | Role | What they receive |
|---|---|---|
| Control group (CG) | No intervention | Those subjects randomized to the CG will be offered reading options that do not evoke high emotional distress. They will spend an hour reading. |
| Stretching protocol 1, Mild Stretching Group (MSG) | Experimental | The protocol starts with 5 minutes of instruction about finding a range of stretching representing approximately 50% of the range of motion and pain-free. The instructor will also wear wrist and ankle reflective bands as body-marks to show a posture with 100% stretch and then corrected to 50%. Once the participant grasps the concept the routine will begin with 5 minutes of warm-up, followed by stretching exercises targeting 10 anatomical groups. Each posture will last 1 minute divided in 30 seconds of settling into each posture and 30 seconds of holding. Each session will be video recorded to analyze the stretching range, only if the participant agrees at the informed consent visit. Participants will be encouraged to find their own 50% with some feedback from the instructor. Receives: Procedure: Yoga-based stretching |
| Stretching protocol 2, Intense Stretching Group (ISG): | Experimental | The protocol starts with 5 minutes of instruction about finding a range of stretching representing approximately 100% of the range of motion and pain-free. The instructor will also wear wrist and ankle reflective bands as body-marks to show a posture with 100% stretch. Once the participant grasps the concept the routine will begin with 5 minutes of warm-up, followed by stretching exercises targeting 10 anatomical groups. Each posture will last 1 minute divided in 30 seconds of settling into each posture and 30 seconds of holding. Each session will be video recorded to analyze the stretching range, only if the participant agrees at the informed consent visit. Participants will be encouraged to find their own 100% with some feedback from the instructor. Receives: Procedure: Yoga-based stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a pilot study including one session of acute stretching and serial blood samples over a period of 24 hours.
- Study recruitment will be completed within 9 months
- >70% of participants will complete two study visits
- Participants will adhere to study protocol, including completion of outcome assessments (> 90%) and complying with stretching instructions specific to the mild and intense stretching protocol (confirmed with video analysis)
- There will be no serious adverse events reported.
Measured: Two consecutive study visits per participants over a period of 24 hours
Secondary outcomes (2)
Systemic inflammatory cytokines
Cytokines (IL-1b, IFN-a2, IFN-y, TNF-a, MCP-1, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33) Serum levels in pg/mL
Measured: Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention.
Specialized pro-resolving mediators (SPMs)
Lipid mediators
Measured: Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start30 Jan 2020
- Primary completion30 May 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is a pilot randomized clinical trial (RCT) with 3 arms. These arms are: Control Group, Mild Stretching Group, and Intense Stretching Group. Ten participants will be allocated in each arm.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard University Faculty of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Wayne, Harvard University Faculty of Medicine
- Investigators
- Peter M Wayne, PhD, Principal investigator, Brigham and Women's Hospital and Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444102
- Sponsor's protocol ID
- 2019P001716
- Status last verified
- Jan 2024
- First submitted
- 23 Mar 2020
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of this study may eventually be published, and information may be exchanged between medical investigators and collaborators, but patient confidentiality will be maintained. Institutional Review Board and regulatory authorities will be granted direct access to original medical and research records for verification of clinical trial procedures and/or data. If the record is used or disseminated for government purposes, it will be done under conditions that will protect the subject's privacy consistent with laws relating to public disclosure of information and the law-enforcement responsibilities of the agency (e.g. NIH and FDA).
Publications
Ding D, Stamatakis E. Yoga practice in England 1997-2008: prevalence, temporal trends, and correlates of participation. BMC Res Notes. 2014 Mar 24;7:172. doi: 10.1186/1756-0500-7-172.
PubMed 24661723Tindle HA, Davis RB, Phillips RS, Eisenberg DM. Trends in use of complementary and alternative medicine by US adults: 1997-2002. Altern Ther Health Med. 2005 Jan-Feb;11(1):42-9.
PubMed 15712765Clarke TC, Barnes PM, Black LI, Stussman BJ, Nahin RL. Use of Yoga, Meditation, and Chiropractors Among U.S. Adults Aged 18 and Over. NCHS Data Brief. 2018 Nov;(325):1-8.
PubMed 30475686Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.
PubMed 24470004Ospina MB, Bond K, Karkhaneh M, Tjosvold L, Vandermeer B, Liang Y, Bialy L, Hooton N, Buscemi N, Dryden DM, Klassen TP. Meditation practices for health: state of the research. Evid Rep Technol Assess (Full Rep). 2007 Jun;(155):1-263.
PubMed 17764203Ebnezar J, Nagarathna R, Yogitha B, Nagendra HR. Effect of integrated yoga therapy on pain, morning stiffness and anxiety in osteoarthritis of the knee joint: A randomized control study. Int J Yoga. 2012 Jan;5(1):28-36. doi: 10.4103/0973-6131.91708.
PubMed 22346063Langevin HM. Connective tissue: a body-wide signaling network? Med Hypotheses. 2006;66(6):1074-7. doi: 10.1016/j.mehy.2005.12.032. Epub 2006 Feb 17.
PubMed 16483726Benias PC, Wells RG, Sackey-Aboagye B, Klavan H, Reidy J, Buonocore D, Miranda M, Kornacki S, Wayne M, Carr-Locke DL, Theise ND. Structure and Distribution of an Unrecognized Interstitium in Human Tissues. Sci Rep. 2018 Mar 27;8(1):4947. doi: 10.1038/s41598-018-23062-6.
PubMed 29588511Wosczyna MN, Rando TA. A Muscle Stem Cell Support Group: Coordinated Cellular Responses in Muscle Regeneration. Dev Cell. 2018 Jul 16;46(2):135-143. doi: 10.1016/j.devcel.2018.06.018.
PubMed 30016618Levy BD, Clish CB, Schmidt B, Gronert K, Serhan CN. Lipid mediator class switching during acute inflammation: signals in resolution. Nat Immunol. 2001 Jul;2(7):612-9. doi: 10.1038/89759.
PubMed 11429545Serhan CN, Savill J. Resolution of inflammation: the beginning programs the end. Nat Immunol. 2005 Dec;6(12):1191-7. doi: 10.1038/ni1276.
PubMed 16369558Berrueta L, Muskaj I, Olenich S, Butler T, Badger GJ, Colas RA, Spite M, Serhan CN, Langevin HM. Stretching Impacts Inflammation Resolution in Connective Tissue. J Cell Physiol. 2016 Jul;231(7):1621-7. doi: 10.1002/jcp.25263. Epub 2015 Dec 10.
PubMed 26588184Munoz-Vergara D, Schreiber KL, Langevin H, Yeh GY, Zhu Y, Rist P, Wayne PM. The Effects of a Single Bout of High- or Moderate-Intensity Yoga Exercise on Circulating Inflammatory Mediators: A Pilot Feasibility Study. Glob Adv Health Med. 2022 Dec 11;11:2164957X221145876. doi: 10.1177/2164957X221145876. eCollection 2022.
PubMed 36583069
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Impact of Yoga-based Stretching on Inflammation and Its Resolution: a Pilot Study
- ClinicalTrials.gov ID
- NCT04444102
- Acronym / sponsor ID
- 2019P001716
- Keywords
- stretching, yoga, mind-body therapies, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Harvard University Faculty of MedicineUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 23 Jun 2020 (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 goal of this study is to explore the impact of two types of yoga-based body stretching (mild and intense) on dynamic changes of Systemic Inflammatory Cytokines (SICs) and Specialized Pro-resolving Mediators (SPMs) in yoga-naïve subjects.
Detailed description
During the last decade, yoga has become increasingly popular in Western cultures. The 2017 NIH report indicated that 14.3% of the adult population practice yoga in the USA. The most common yoga styles tested in randomized clinical trials (RCTs) are Hatha, Iyengar, and Patanjali.
One key physical component of yoga is the stretching that occurs during different postures. Based on animal studies, it is plausible to think that the physical intensity of stretching may affect systemic inflammatory outcomes, i.e. SICs and SPMs. However, human studies have not isolated and quantified the impact of stretching. In consequence, it is not known to what extent the benefits of yoga can be attributed to the physical aspect of stretching. One way to explore the effect of yoga would be to isolate the stretching element and compare two stretching protocols with yoga-based postures on SICs and SPMs.
In previous preclinical studies using an ex-vivo stretching model of mouse connective tissue (AICUC: 04996), the investigators found that fibroblasts are actively involved in the regulation of connective tissue tension, demonstrating that fibroblasts have a more elaborate scheme of responses to mechanical stress than was previously thought.
Later, in the inflammatory active stretch rat model (AICUC 04995), the investigators found that after 10 minutes of an active stretch there was a significant reduction in the inflammatory lesion size area measured with ultrasound and a reduction of infiltrating neutrophils. The SPM Resolvin 1 (RvD1) was also measured and showed a significant difference between the stretch and no stretch group. These promising results encouraged the investigators to keep exploring the fundamental innate mechanism by which the body enhances the healing of an inflammatory process regardless of its etiology; e.g., a mouse breast cancer model with active stretch showed that with four weeks of stretching once a day, tumors were reduced roughly to the half comparing with the no-stretch group and a pig study currently underway is exploring the effects of active stretching on SPMs production and determining changes in Polymorphonuclear Neutrophil (PMN) and macrophages migration toward the inflammatory stimulus.
These pre-clinical results motivated the research group to move forward with a translational pilot study to explore first the feasibility and second, the effect of stretching on the connective tissue and muscles of healthy humans. The investigators presume to find an effect of stretching on a systemic level. Hence, they propose to measure levels of SICs and SPMs, as well as their changes over time after one acute session of yoga-based stretching postures. The investigators plan to collect blood samples at baseline pre-intervention and then at 0 minutes, 30 minutes, 1, 2, and 3, and 24 hours after the intervention. Samples will be analyzed using flow cytometry and ELISA.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The present study is a pilot randomized clinical trial (RCT) with 3 arms. These arms are: Control Group, Mild Stretching Group, and Intense Stretching Group. Ten participants will be allocated in each arm.
| Arm | Type | Receives |
|---|---|---|
| Control group (CG) | No intervention | –Those subjects randomized to the CG will be offered reading options that do not evoke high emotional distress. They will spend an hour reading. |
| Stretching protocol 1, Mild Stretching Group (MSG) | Experimental | Procedure: Yoga-based stretchingThe protocol starts with 5 minutes of instruction about finding a range of stretching representing approximately 50% of the range of motion and pain-free. The instructor will also wear wrist and ankle reflective bands as body-marks to show a posture with 100% stretch and then corrected to 50%. Once the participant grasps the concept the routine will begin with 5 minutes of warm-up, followed by stretching exercises targeting 10 anatomical groups. Each posture will last 1 minute divided in 30 seconds of settling into each posture and 30 seconds of holding. Each session will be video recorded to analyze the stretching range, only if the participant agrees at the informed consent visit. Participants will be encouraged to find their own 50% with some feedback from the instructor. |
| Stretching protocol 2, Intense Stretching Group (ISG): | Experimental | Procedure: Yoga-based stretchingThe protocol starts with 5 minutes of instruction about finding a range of stretching representing approximately 100% of the range of motion and pain-free. The instructor will also wear wrist and ankle reflective bands as body-marks to show a posture with 100% stretch. Once the participant grasps the concept the routine will begin with 5 minutes of warm-up, followed by stretching exercises targeting 10 anatomical groups. Each posture will last 1 minute divided in 30 seconds of settling into each posture and 30 seconds of holding. Each session will be video recorded to analyze the stretching range, only if the participant agrees at the informed consent visit. Participants will be encouraged to find their own 100% with some feedback from the instructor. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults
- Age between 40 - 60 years old.
- Non-smoking
- BMI between 19 and 29.
Key exclusion criteria (11 listed)
- Any history of chronic inflammatory disease or recent acute illness (< 1 month)
- Vaccination within the last 3 months
- Regular medication, or any medication in the preceding week
- Practice of structured higher-intensity exercise at least twice a week for more than 30 minutes
- Pregnancy
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 |
|---|---|---|
| Yoga-based stretchingDifferent yoga postures (ASANA) were isolated from conventional yoga practice to stretch different muscle groups. Muscle groups stretched: hip extensor and adductors, hip \& plantar flexors, shoulder extensors, shoulder horizontal adductors, shoulder extensors-adductor, wrist flexor, trunk extensors, lateral flexors, and trunk rotators. | Procedure or surgery | Stretching protocol 1, Mild Stretching Group (MSG), Stretching protocol 2, Intense Stretching Group (ISG): |
Primary outcome
Feasibility of a pilot study including one session of acute stretching and serial blood samples over a period of 24 hours.
Time frame: Two consecutive study visits per participants over a period of 24 hours
* Study recruitment will be completed within 9 months * >70% of participants will complete two study visits * Participants will adhere to study protocol, including completion of outcome assessments (> 90%) and complying with stretching instructions specific to the mild and intense stretching protocol (confirmed with video analysis) * There will be no serious adverse events reported.
2 secondary outcomes
Systemic inflammatory cytokines
Time frame: Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention.
Specialized pro-resolving mediators (SPMs)
Time frame: Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Results publication: PubMed 24661723Ding D, Stamatakis E. Yoga practice in England 1997-2008: prevalence, temporal trends, and correlates of participation. BMC Res Notes. 2014 Mar 24;7:172. doi: 10.1186/1756-0500-7-172.
- Results publication: PubMed 15712765Tindle HA, Davis RB, Phillips RS, Eisenberg DM. Trends in use of complementary and alternative medicine by US adults: 1997-2002. Altern Ther Health Med. 2005 Jan-Feb;11(1):42-9.
- Results publication: PubMed 30475686Clarke TC, Barnes PM, Black LI, Stussman BJ, Nahin RL. Use of Yoga, Meditation, and Chiropractors Among U.S. Adults Aged 18 and Over. NCHS Data Brief. 2018 Nov;(325):1-8.
- Results publication: PubMed 24470004Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.
- Results publication: PubMed 17764203Ospina MB, Bond K, Karkhaneh M, Tjosvold L, Vandermeer B, Liang Y, Bialy L, Hooton N, Buscemi N, Dryden DM, Klassen TP. Meditation practices for health: state of the research. Evid Rep Technol Assess (Full Rep). 2007 Jun;(155):1-263.
- Results publication: PubMed 22346063Ebnezar J, Nagarathna R, Yogitha B, Nagendra HR. Effect of integrated yoga therapy on pain, morning stiffness and anxiety in osteoarthritis of the knee joint: A randomized control study. Int J Yoga. 2012 Jan;5(1):28-36. doi: 10.4103/0973-6131.91708.
- Results publication: PubMed 16483726Langevin HM. Connective tissue: a body-wide signaling network? Med Hypotheses. 2006;66(6):1074-7. doi: 10.1016/j.mehy.2005.12.032. Epub 2006 Feb 17.
- Results publication: PubMed 29588511Benias PC, Wells RG, Sackey-Aboagye B, Klavan H, Reidy J, Buonocore D, Miranda M, Kornacki S, Wayne M, Carr-Locke DL, Theise ND. Structure and Distribution of an Unrecognized Interstitium in Human Tissues. Sci Rep. 2018 Mar 27;8(1):4947. doi: 10.1038/s41598-018-23062-6.
- Results publication: PubMed 30016618Wosczyna MN, Rando TA. A Muscle Stem Cell Support Group: Coordinated Cellular Responses in Muscle Regeneration. Dev Cell. 2018 Jul 16;46(2):135-143. doi: 10.1016/j.devcel.2018.06.018.
- Results publication: PubMed 11429545Levy BD, Clish CB, Schmidt B, Gronert K, Serhan CN. Lipid mediator class switching during acute inflammation: signals in resolution. Nat Immunol. 2001 Jul;2(7):612-9. doi: 10.1038/89759.
- Results publication: PubMed 16369558Serhan CN, Savill J. Resolution of inflammation: the beginning programs the end. Nat Immunol. 2005 Dec;6(12):1191-7. doi: 10.1038/ni1276.
- Results publication: PubMed 26588184Berrueta L, Muskaj I, Olenich S, Butler T, Badger GJ, Colas RA, Spite M, Serhan CN, Langevin HM. Stretching Impacts Inflammation Resolution in Connective Tissue. J Cell Physiol. 2016 Jul;231(7):1621-7. doi: 10.1002/jcp.25263. Epub 2015 Dec 10.
- Individual participant dataSharing planned: No. The results of this study may eventually be published, and information may be exchanged between medical investigators and collaborators, but patient confidentiality will be maintained. Institutional Review Board and regulatory authorities will be granted direct access to original medical and research records for verification of clinical trial procedures and/or data. If the record is used or disseminated for government purposes, it will be done under conditions that will protect the subject's privacy consistent with laws relating to public disclosure of information and the law-enforcement responsibilities of the agency (e.g. NIH and FDA).
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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.
Peter M Wayne, PhD principal investigator
Brigham and Women's Hospital and Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga-based stretching in people with Inflammation and Fascia; Inflammation, run by Harvard University Faculty of Medicine 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Jan 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?
Results are not available in the source record.
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?
Feasibility of a pilot study including one session of acute stretching and serial blood samples over a period of 24 hours. (time frame: Two consecutive study visits per participants over a period of 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04444102, which also lists 13 linked publications.
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 16 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.