Flow-Restorative Yoga to Decrease Pain and Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2019-05-05

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Pain Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Randomization to arm follows the baseline assessment visit.

Study Groups

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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.

Group Type EXPERIMENTAL

Restorative-Flow Yoga

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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