- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04343625
Feasibility Study of a Modified Yoga Program for Elders
April 10, 2020 updated by: Cheryl LaMore, University of Michigan
Feasibility of a Modified Yoga Program to Improve Pain in an Assisted Living Facility
The purpose of this study is to determine whether a modified yoga program helps improve pain and function in elders age 65 years or older living in an assisted living community.
Participation in regular physical activity, such as yoga, may improve strength and mobility and decrease pain.
This study was developed to ascertain whether a modified yoga program improves pain and function in assisted-living elders, age 65 years and older.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chronic pain is costly and debilitating, affecting an estimated 100 million Americans and costing about $600 billion a year in indirect and direct medical costs.
Managing chronic pain is difficult, requiring an array of pharmacologic and non-pharmacologic approaches to address not only pain, but relevant and intertwined domains of life such as sleep, energy, and mood.
One such non-pharmacologic therapy is yoga.
Systematic reviews of yoga clinical trials have shown that yoga is effective in managing low back and neck pain.
However, these studies utilized younger populations, and no studies have characterized the effects of yoga for pain in the elderly.
Given the rapidly growing aged population, the growing popularity of yoga, and the high prevalence of pain conditions among elderly individuals, studies that examine the effect of yoga on acute and chronic pain in the elderly are warranted.
Thus the purpose of this proposal is to perform a pilot study to assess the feasibility and efficacy of yoga for managing chronic pain in elderly adults.
This study will characterize whether such an intervention is feasible, assess whether a gentle yoga intervention improves subjective symptoms of pain, and investigate whether this yoga interventions decreases use of as needed pain relievers among elderly adults.
This pilot study will characterize these effects in a sample of 60 elderly adults in at the United Methodist Retirement community in Chelsea, Michigan.
The results of this study will be immediately translatable to members of this community in the short term, and nationwide in the long term.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48106
- Dominos Farms
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Report chronic (>3months) clinically relevant pain, defined as a score of ≥3 on a 0-10 numeric pain scale, at least 3 of 7 days per week
- Must be current resident of the United Methodist Retirement Community or Silver Maples Assisted Living Community with medical record availability regarding medication use over the previous 10 weeks
Exclusion Criteria:
- Persons who have not lived at the facility long enough to analyze their medical records
- Having any medical condition or lack of physical capability that would prohibit safe participation in yoga exercise
- No regular yoga practice (regular yoga practice defined as ≥1 practice session/week)
- Cannot provide informed consent for study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Modified sitting, gentle yoga class
Participants attended a modified sitting gentle yoga class,10 weekly classes, each 60 minutes in duration.
|
Modified yoga was used to see if it would improve pain, fatigue, depression and anxiety, as well as improve sleep quality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Severity
Time Frame: 20 weeks
|
The Brief Pain Inventory (BPI) is a 15-item self-report measure that has been validated for use in a wide variety of pain states.
The BPI assesses for the presence of pain, pain intensity (i.e., worst, least, average, current) and functional interference from pain.
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression and anxiety as measured by The HADS scale
Time Frame: 20 weeks
|
The Hospital Anxiety and Depression Scale (HADS) is a brief 14-item instrument that will be used to classify individuals as having normal, mild, moderate, or severe levels of anxiety and depressive symptoms
|
20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Cheryl E LaMore, MD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2018
Primary Completion (Actual)
August 8, 2019
Study Completion (Actual)
August 8, 2019
Study Registration Dates
First Submitted
April 9, 2020
First Submitted That Met QC Criteria
April 10, 2020
First Posted (Actual)
April 13, 2020
Study Record Updates
Last Update Posted (Actual)
April 13, 2020
Last Update Submitted That Met QC Criteria
April 10, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00128999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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