Flow-Restorative Yoga to Decrease Pain and Inflammation

• ClinicalTrials.gov Identifier: NCT03790098
• Recruitment Status: Completed
• First Posted: December 31, 2018
• Last Update Posted: July 23, 2019
• Sponsor: Cornell University
• Information provided by (Responsible Party): Rebecca Seguin, Cornell University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain; Inflammation	Behavioral: Restorative-Flow Yoga	Not Applicable

Detailed Description:

The aims of the study are to (1) evaluate the feasibility of implementing a restorative-flow yoga randomized trial (24 classes, held twice per week) for women aged 60 or older who experience chronic pain; and (2) evaluate the preliminary efficacy of restorative-flow yoga to decrease pain and inflammation among women aged 60 or older. Feasibility measures will include three areas of focus (a) acceptability, (b) implementation, and (c) demand and use, evaluated using recruitment rate, retention rate, class and home practice adherence rates, resource utilization, and safety. With a sample size of 40, this pilot feasibility study is likely under-powered to determine intervention effects. However, the study will evaluate preliminary efficacy of the yoga intervention. The study will measure BMI, blood pressure, resting heart rate, physical function measures, and inflammatory markers C-reactive protein, IL-2, IL-1β, TNF-α, IL-6, IL-4, and IL-10) at baseline and outcome assessments (after 24 class sequence).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Masking Description: Randomization to arm follows the baseline assessment visit.
• Primary Purpose: Treatment
• Official Title: Can Yoga Decrease Pain and Inflammation Among Women Aged 60 or Older: A Pilot Feasibility Study
• Actual Study Start Date: November 19, 2018
• Actual Primary Completion Date: April 27, 2019
• Actual Study Completion Date: May 5, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Yoga Class Participants; 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; 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.
No Intervention: No Classes; 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.

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in inflammatory markers [ Time Frame: Baseline and outcome (after 24 class sequence, about 14 weeks) ]
   Change from baseline measures of C-reactive protein, IL-2, IL-1β, TNF-α, IL-6, IL-4, and IL-10
2. Change from baseline in Average Pain on The Brief Pain Inventory [ Time Frame: Baseline and outcome (after 24 class sequence, about 14 weeks) ]
   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.

Secondary Outcome Measures :

1. Change from baseline in the 'Chair Stand Test' [ Time Frame: Baseline and outcome (after 24 class sequence, about 14 weeks) ]
   The 'Chair Stand Test' is a count of the number of full stands that can be completed in 30 seconds with arms folded across chest. It is one of six functional fitness/ senior fitness tests that will be measured at baseline and outcome to assess change from baseline.
2. Change from baseline in the 'Arm Curl Test' [ Time Frame: Baseline and outcome (after 24 class sequence, about 14 weeks) ]
   The 'Arm Curl Test' is a count of the number of bicep curls that can be completed in 30 seconds holding a hand weight of 5 lbs. for women. It is one of six functional fitness/ senior fitness tests that will be measured at baseline and outcome to assess change from baseline.
3. Change from baseline in the '2-Minute Step Test' [ Time Frame: Baseline and outcome (after 24 class sequence, about 14 weeks) ]
   The '2-Minute Step Test' is a count of the number of full steps completed in 2 minutes, raising each knee to a point midway between the kneecap and hip bone. It is one of six functional fitness/ senior fitness tests that will be measured at baseline and outcome to assess change from baseline.
4. Change from baseline in the 'Chair Sit-and-Reach Test' [ Time Frame: Baseline and outcome (after 24 class sequence, about 14 weeks) ]
   The 'Chair Sit-and-Reach Test' is a measure of the distance that a participant can reach toward or past her toes when stretching forward from a seated position. It is one of six functional fitness/ senior fitness tests that will be measured at baseline and outcome to assess change from baseline.
5. Change from baseline in the 'Back Scratch Test' [ Time Frame: Baseline and outcome (after 24 class sequence, about 14 weeks) ]
   The 'Back Scratch Test' is a measure of the distance or overlap between her fingers, as a participant reaches behind her back. It is one of six functional fitness/ senior fitness tests that will be measured at baseline and outcome to assess change from baseline.
6. Change from baseline in the '8-foot up and go' [ Time Frame: Baseline and outcome (after 24 class sequence, about 14 weeks) ]
   The '8-foot up and go' is measure of the number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position. It is one of six functional fitness/ senior fitness tests that will be measured at baseline and outcome to assess change from baseline.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, New York

Cornell University

Ithaca, New York, United States, 14853

Sponsors and Collaborators

Cornell University

Investigators

• Principal Investigator: Rebecca A Seguin, PhD; Cornell University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Rebecca Seguin, Principal Investigator, Cornell University
• ClinicalTrials.gov Identifier: NCT03790098
• Other Study ID Numbers: 1809008271
• First Posted: December 31, 2018
• Last Update Posted: July 23, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Inflammation; Pathologic Processes