The Acute Impact of Yoga-based Stretching on Inflammation and Its Resolution

Inflammation Clinical Trial

Official title:

The Acute Impact of Yoga-based Stretching on Inflammation and Its Resolution: a Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04444102
• Other study ID #: 2019P001716
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: Harvard University Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy adults
• Age between 40 - 60 years old.
• Non-smoking
• BMI between 19 and 29.

Exclusion Criteria:

• 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)
• 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.

Related Conditions & MeSH terms

• Fascia; Inflammation
• Fasciitis
• Inflammation
• Low Back Pain
• Lower Back Pain
• Musculoskeletal Pain
• Neck Pain

Intervention

Procedure:
• Yoga-based stretching
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.

Locations

Country	Name	City	State
United States	Ambulatory Clinical Center (ACC)	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard University Faculty of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (12)

Benias 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/s415 — View Citation

Berrueta 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. — View Citation

Clarke 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. — View Citation

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. — View Citation

Ebnezar 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. — View Citation

Kiecolt-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 — View Citation

Langevin 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. — View Citation

Levy 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. — View Citation

Ospina 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. — View Citation

Serhan CN, Savill J. Resolution of inflammation: the beginning programs the end. Nat Immunol. 2005 Dec;6(12):1191-7. doi: 10.1038/ni1276. — View Citation

Tindle 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. — View Citation

Wosczyna 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two consecutive study visits per participants over a period of 24 hours
Secondary	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	Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention.
Secondary	Specialized pro-resolving mediators (SPMs)	Lipid mediators	Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention.