PainNCT03790098
Flow-Restorative Yoga to Decrease Pain and Inflammation
A study testing Restorative-Flow Yoga in people with Pain and Inflammation, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Inflammation
- What is being tested?
- Restorative-Flow Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 5 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently practicing yoga two or more times per week
- Cognitively impaired
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Yoga Decrease Pain and Inflammation Among Women Aged 60 or Older: A Pilot Feasibility Study
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.
Read the 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).
- Conditions
- Pain, Inflammation
- Being tested
- Restorative-Flow Yoga
- Medical subject headings
- Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorative-Flow YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Class Participants | Experimental | 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. Receives: Behavioral: Restorative-Flow Yoga |
| No Classes | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in inflammatory markers
Change from baseline measures of C-reactive protein, IL-2, IL-1β, TNF-α, IL-6, IL-4, and IL-10
Measured: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in Average Pain on The Brief Pain Inventory
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.
Measured: Baseline and outcome (after 24 class sequence, about 14 weeks)
Secondary outcomes (6)
Change from baseline in the 'Chair Stand Test'
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.
Measured: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in the 'Arm Curl Test'
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.
Measured: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in the '2-Minute Step Test'
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.
Measured: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in the 'Chair Sit-and-Reach Test'
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.
Measured: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in the 'Back Scratch Test'
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.
Measured: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in the '8-foot up and go'
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.
Measured: Baseline and outcome (after 24 class sequence, about 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start19 Nov 2018
- Primary completion27 Apr 2019
- Study completion5 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- M. Cary Reid, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790098
- Sponsor's protocol ID
- 1809008271
- Other IDs
- P30AG022845
- Status last verified
- Mar 2022
- First submitted
- 19 Dec 2018
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33046009
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Yoga Decrease Pain and Inflammation Among Women Aged 60 or Older: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT03790098
- Acronym / sponsor ID
- 1809008271
- Conditions
- Pain, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Cornell University, National Institute on Aging (NIA)
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 27 Apr 2019 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Yoga Class Participants | Experimental | Behavioral: Restorative-Flow YogaGroup 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. |
| No Classes | No intervention | –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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Currently practicing yoga two or more times per week
- Cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restorative-Flow YogaRestorative 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. | Behavioural | Yoga Class Participants |
Primary outcome
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
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.
6 secondary outcomes
Change from baseline in the 'Chair Stand Test'
Time frame: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in the 'Arm Curl Test'
Time frame: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in the '2-Minute Step Test'
Time frame: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in the 'Chair Sit-and-Reach Test'
Time frame: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in the 'Back Scratch Test'
Time frame: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline in the '8-foot up and go'
Time frame: Baseline and outcome (after 24 class sequence, about 14 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Derived from this study: PubMed 33046009Seguin-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Cary Reid, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restorative-Flow Yoga in people with Pain and Inflammation, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in inflammatory markers (time frame: Baseline and outcome (after 24 class sequence, about 14 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03790098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.