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Flow-Restorative Yoga to Decrease Pain and Inflammation

Primary Purpose

Pain, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restorative-Flow Yoga
Sponsored by
Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cornell University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga Class Participants

No Classes

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Change from baseline in the 'Chair Stand Test'
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.
Change from baseline in the 'Arm Curl Test'
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.
Change from baseline in the '2-Minute Step Test'
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.
Change from baseline in the 'Chair Sit-and-Reach Test'
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.
Change from baseline in the 'Back Scratch Test'
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.
Change from baseline in the '8-foot up and go'
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.

Full Information

First Posted
December 19, 2018
Last Updated
March 8, 2022
Sponsor
Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT03790098
Brief Title
Flow-Restorative Yoga to Decrease Pain and Inflammation
Official Title
Can Yoga Decrease Pain and Inflammation Among Women Aged 60 or Older: A Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
April 27, 2019 (Actual)
Study Completion Date
May 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University

4. Oversight

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

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Class Participants
Arm Type
Experimental
Arm Description
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.
Arm Title
No Classes
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Restorative-Flow Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in inflammatory markers
Description
Change from baseline measures of C-reactive protein, IL-2, IL-1β, TNF-α, IL-6, IL-4, and IL-10
Time Frame
Baseline and outcome (after 24 class sequence, about 14 weeks)
Title
Change from baseline in Average Pain on The Brief Pain Inventory
Description
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.
Time Frame
Baseline and outcome (after 24 class sequence, about 14 weeks)
Secondary Outcome Measure Information:
Title
Change from baseline in the 'Chair Stand Test'
Description
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.
Time Frame
Baseline and outcome (after 24 class sequence, about 14 weeks)
Title
Change from baseline in the 'Arm Curl Test'
Description
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.
Time Frame
Baseline and outcome (after 24 class sequence, about 14 weeks)
Title
Change from baseline in the '2-Minute Step Test'
Description
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.
Time Frame
Baseline and outcome (after 24 class sequence, about 14 weeks)
Title
Change from baseline in the 'Chair Sit-and-Reach Test'
Description
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.
Time Frame
Baseline and outcome (after 24 class sequence, about 14 weeks)
Title
Change from baseline in the 'Back Scratch Test'
Description
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.
Time Frame
Baseline and outcome (after 24 class sequence, about 14 weeks)
Title
Change from baseline in the '8-foot up and go'
Description
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.
Time Frame
Baseline and outcome (after 24 class sequence, about 14 weeks)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca A Seguin, PhD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornell University
City
Ithaca
State/Province
New York
ZIP/Postal Code
14853
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33046009
Citation
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.
Results Reference
derived

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Flow-Restorative Yoga to Decrease Pain and Inflammation

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