Clinical trial NCT04343625: Feasibility Study of a Modified Yoga Program for Elders
Official title: Feasibility of a Modified Yoga Program to Improve Pain in an Assisted Living Facility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Fatigue
Pain, Chronic
Sleep
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: 5 Healthy Towns Foundation
First posted: 2020-04-13
Enrollment: 28
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Severity
timeFrame: 20 weeks
Secondary outcomes:
measure: Depression and anxiety as measured by The HADS scale
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Dominos Farms
state: Michigan
Study officials:
affiliation: University of Michigan
name: Cheryl E LaMore, MD
role: PRINCIPAL_INVESTIGATOR
References: