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CompletedNCT04343625Updated Apr 13, 2020

Feasibility Study of a Modified Yoga Program for Elders

An interventional study of Modified yoga class in Depression, Anxiety, Fatigue and Pain, Chronic, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-13.

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled May 2018, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression, Anxiety
  • Fatigue
  • Pain, Chronic
  • Sleep

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 28 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Modified sitting, gentle yoga class

    Participants attended a modified sitting gentle yoga class,10 weekly classes, each 60 minutes in duration.

    Behavioral: Modified yoga class

Interventions

  • BehavioralModified yoga class

    Modified yoga was used to see if it would improve pain, fatigue, depression and anxiety, as well as improve sleep quality.

06

What researchers measure

Primary outcomes

  1. Pain Severity

    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.

    Time frame: 20 weeks

Secondary outcomes

  1. Depression and anxiety as measured by The HADS scale

    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

    Time frame: 20 weeks

07

Study locations

1 site
  • Dominos Farms
    Ann Arbor, Michigan 48106, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04343625
Lead sponsor
University of Michigan
Collaborators
5 Healthy Towns Foundation
Responsible party
Cheryl LaMore (Assistant Professor, University of Michigan) — Principal investigator
First posted
Apr 13, 2020
Start date
May 23, 2018
Primary completion
Aug 8, 2019
Completion
Aug 8, 2019
Last update
Apr 13, 2020

Study contacts

Cheryl E LaMore, MD
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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