Flow-Restorative Yoga to Decrease Pain and Inflammation

Cornell University

Status: Completed

Conditions: Inflammation; Pain

Treatments: Behavioral: Restorative-Flow Yoga

Study type: Interventional

Funder types: Other

Identifiers

NCT03790098

1809008271

Details and patient eligibility

About

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.

Full 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).

Enrollment: 38 patients

Sex: Female

Ages: 60+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Yoga Class Participants

Experimental group

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.

Treatment:

Behavioral: Restorative-Flow Yoga

No Classes

No Intervention group

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.