Flow-Restorative Yoga to Decrease Pain and Inflammation
- Conditions
- InflammationPain
- Interventions
- Behavioral: Restorative-Flow Yoga
- Registration Number
- NCT03790098
- Lead Sponsor
- Cornell University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 38
- 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
- Currently practicing yoga two or more times per week
- Cognitively impaired
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Yoga Class Participants Restorative-Flow Yoga 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 '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 '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 '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.
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 '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.
Trial Locations
- Locations (1)
Cornell University
🇺🇸Ithaca, New York, United States