Flow-Restorative Yoga to Decrease Pain and Inflammation

NCT03790098 | Completed

• 1 other identifier: 1809008271
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The Restorative Flow Yoga Study is a pilot project looking at whether restorative flow yoga will reduce inflammation and pain in women 60 and older who experience chronic pain.

Conditions

Pain; Inflammation

Outcome Measures

Primary Outcomes (2)

• Change from baseline in inflammatory markers

  Change from baseline measures of C-reactive protein, IL-2, IL-1β, TNF-α, IL-6, IL-4, and IL-10

  Baseline and outcome (after 24 class sequence, about 14 weeks)

• Change from baseline in Average Pain on The Brief Pain Inventory

  Change from baseline self-report of AVERAGE pain on the severity scale of the The Brief Pain Inventory (BPI) where where 0=no pain and 10=pain as bad as you can imagine. The BPI is a widely used measurement tool for assessing clinical pain.

  Baseline and outcome (after 24 class sequence, about 14 weeks)

Secondary Outcomes (6)

• Change from baseline in the 'Chair Stand Test'

  Baseline and outcome (after 24 class sequence, about 14 weeks)

• Change from baseline in the 'Arm Curl Test'

  Baseline and outcome (after 24 class sequence, about 14 weeks)

• Change from baseline in the '2-Minute Step Test'

  Baseline and outcome (after 24 class sequence, about 14 weeks)

• Change from baseline in the 'Chair Sit-and-Reach Test'

  Baseline and outcome (after 24 class sequence, about 14 weeks)

• Change from baseline in the 'Back Scratch Test'

  Baseline and outcome (after 24 class sequence, about 14 weeks)

Study Arms (2)

Yoga Class Participants

EXPERIMENTAL

Group 1 participants will meet twice per week for one hour to practice restorative-flow yoga with a certified yoga instructor. There will be a total of 24 classes. Group 1 participants will also receive an at-home supplemental booklet, a yoga video led by the class instructor, and encouragement to practice two additional days each week at home. They will be asked to fill out a form to record their at-home practice.

Behavioral: Restorative-Flow Yoga

No Classes

NO INTERVENTION

Group 2 participants will not attend yoga classes as part of the study and will be asked not to begin yoga classes outside the study. After the 24 classes, they will be given the 'at-home' supplemental materials.

Interventions

Restorative-Flow Yoga BEHAVIORAL

Restorative yoga consists of a series of gentle poses, supported by props, with an emphasis on breathing and relaxing; as opposed to stretching or contracting muscles, it is designed to support muscles. Flow yoga consists of a series of linked poses synchronized with the breath.

Yoga Class Participants

Eligibility Criteria

• Age: 60 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age 60 or older
• Report AVERAGE severity of 3 or higher on the brief pain inventory
• Blood pressure is less than 160/100 mm Hg
• Heart rate is between 55-110 bpm
• Able and willing to obtain physician's approval to participate

You may not qualify if:

• Currently practicing yoga two or more times per week
• Cognitively impaired

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Cornell University

Ithaca, New York, 14853, United States

Location

Related Publications (1)

• Seguin-Fowler R, Graham M, Ward J, Eldridge G, Sriram U, Fine D. Feasibility of a yoga intervention to decrease pain in older women: a randomized controlled pilot study. BMC Geriatr. 2020 Oct 12;20(1):400. doi: 10.1186/s12877-020-01818-y.

  PMID: 33046009 DERIVED

MeSH Terms

Conditions

Pain; Inflammation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Rebecca A Seguin, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization to arm follows the baseline assessment visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1 Participants attend Restorative-Flow Yoga classes, two times per week with a certified yoga instructor and have at-home supplemental materials. Group 2 receive the at-home supplemental materials after outcome visit corresponding to after the 24 classes.

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 31, 2018
• Study Start: November 19, 2018
• Primary Completion: April 27, 2019
• Study Completion: May 5, 2019
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)