Flow-Restorative Yoga to Decrease Pain and Inflammation

Pain Clinical Trial

Official title:

Can Yoga Decrease Pain and Inflammation Among Women Aged 60 or Older: A Pilot Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790098
• Other study ID #: 1809008271
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: May 5, 2019

Study information

• Verified date: March 2022
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 5, 2019
• Est. primary completion date: April 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Cornell University	Ithaca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in inflammatory markers	Change from baseline measures of C-reactive protein, IL-2, IL-1ß, TNF-a, IL-6, IL-4, and IL-10	Baseline and outcome (after 24 class sequence, about 14 weeks)
Primary	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	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.	Baseline and outcome (after 24 class sequence, about 14 weeks)
Secondary	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.	Baseline and outcome (after 24 class sequence, about 14 weeks)
Secondary	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.	Baseline and outcome (after 24 class sequence, about 14 weeks)
Secondary	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.	Baseline and outcome (after 24 class sequence, about 14 weeks)
Secondary	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.	Baseline and outcome (after 24 class sequence, about 14 weeks)
Secondary	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.	Baseline and outcome (after 24 class sequence, about 14 weeks)