Inflammation, Pain
Conditions
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).
Interventions
BEHAVIORALRestorative-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.
Sponsors
Weill Medical College of Cornell University
Cornell University
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Randomization to arm follows the baseline assessment visit.
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.
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in inflammatory markers | 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 |
| Change from baseline in Average Pain on The Brief Pain Inventory | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the 'Chair Stand Test' | 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. |
| Change from baseline in the 'Arm Curl Test' | 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. |
| Change from baseline in the '2-Minute Step Test' | 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. |
| Change from baseline in the 'Back Scratch Test' | 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. |
| Change from baseline in the 'Chair Sit-and-Reach Test' | 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. |
| Change from baseline in the '8-foot up and go' | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORM. Cary Reid, MD, PhD
Weill Medical College of Cornell University
Outcome results
None listed