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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammation, Fascia; Inflammation, Musculoskeletal Pain, Lower Back Pain, Neck Pain

Intervention / Treatment
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* Procedure: Yoga-based stretching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group (CG)<br>Those subjects randomized to the CG will be offered reading options that do not evoke high emotional distress. They will spend an hour reading. | |
| Experimental: Stretching protocol 1, Mild Stretching Group (MSG)<br>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. | Procedure: Yoga-based stretching<br>* 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.<br>|
| Experimental: Stretching protocol 2, Intense Stretching Group (ISG):<br>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. | Procedure: Yoga-based stretching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Specialized pro-resolving mediators (SPMs) | Lipid mediators | Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stretching, yoga, mind-body therapies, inflammation