Clinical trial NCT03790098: Flow-Restorative Yoga to Decrease Pain and Inflammation
Official title: Can Yoga Decrease Pain and Inflammation Among Women Aged 60 or Older: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Inflammation
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 38
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in inflammatory markers
timeFrame: Baseline and outcome (after 24 class sequence, about 14 weeks)
measure: Change from baseline in Average Pain on The Brief Pain Inventory
timeFrame: Baseline and outcome (after 24 class sequence, about 14 weeks)
Secondary outcomes:
measure: Change from baseline in the 'Chair Stand Test'
timeFrame: Baseline and outcome (after 24 class sequence, about 14 weeks)
measure: Change from baseline in the 'Arm Curl Test'
timeFrame: Baseline and outcome (after 24 class sequence, about 14 weeks)
measure: Change from baseline in the '2-Minute Step Test'
timeFrame: Baseline and outcome (after 24 class sequence, about 14 weeks)
measure: Change from baseline in the 'Chair Sit-and-Reach Test'
timeFrame: Baseline and outcome (after 24 class sequence, about 14 weeks)
measure: Change from baseline in the 'Back Scratch Test'
timeFrame: Baseline and outcome (after 24 class sequence, about 14 weeks)
measure: Change from baseline in the '8-foot up and go'
timeFrame: Baseline and outcome (after 24 class sequence, about 14 weeks)
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
Study officials:
affiliation: Cornell University
name: Rebecca A Seguin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seguin-Fowler R, Graham M, Ward J, Eldridge G, Sriram U, Fine D. Feasibility of a yoga intervention to decrease pain in older women: a randomized controlled pilot study. BMC Geriatr. 2020 Oct 12;20(1):400. doi: 10.1186/s12877-020-01818-y.