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

NCT04444102 | Unknown

• 1 other identifier: 2019P001716
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

stretching; yoga; mind-body therapies; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Systemic inflammatory cytokines

  Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention.

• Specialized pro-resolving mediators (SPMs)

  Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention.

Study Arms (3)

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.

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.

Procedure: Yoga-based stretching

Interventions

Yoga-based stretching PROCEDURE

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.

Stretching protocol 1, Mild Stretching Group (MSG); Stretching protocol 2, Intense Stretching Group (ISG):

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard University Faculty of Medicine: lead

Study Sites (1)

Ambulatory Clinical Center (ACC)

Boston, Massachusetts, 02115, United States

Location

Related Publications (13)

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  PMID: 26588184 RESULT

• Munoz-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.

  PMID: 36583069 DERIVED

MeSH Terms

Conditions

Inflammation; Fasciitis; Musculoskeletal Pain; Low Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases; Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Back Pain

Study Officials

• Peter M Wayne, PhD

  Brigham and Women's Hospital and Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and yoga-based stretching instructor are not blinded. Nurses and lab technicians are blinded during blood draws. Laboratory analysts are blinded during sample analyses. Statisticians will be unblinded once all laboratory analyses are completed.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: June 23, 2020
• Study Start: January 30, 2020
• Primary Completion: May 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)