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Completed

NCT Number: NCT03790098

Flow-Restorative Yoga to Decrease Pain and Inflammation

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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Key information

Conditions

Pain Inflammation Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cornell University

Ithaca, New York, 14853, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restorative-Flow Yoga

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.

Primary outcomes

  1. Change from baseline in inflammatory markers

    Time frame: 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

  2. Change from baseline in Average Pain on The Brief Pain Inventory

    Time frame: 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 outcomes

  1. Change from baseline in the 'Chair Stand Test'

    Time frame: 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.

  2. Change from baseline in the 'Arm Curl Test'

    Time frame: 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.

  3. Change from baseline in the '2-Minute Step Test'

    Time frame: 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.

  4. Change from baseline in the 'Chair Sit-and-Reach Test'

    Time frame: 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.

  5. Change from baseline in the 'Back Scratch Test'

    Time frame: 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.

  6. Change from baseline in the '8-foot up and go'

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Registry information

Official study title

Can Yoga Decrease Pain and Inflammation Among Women Aged 60 or Older: A Pilot Feasibility Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 31, 2018
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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