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Feasibility Study of a Modified Yoga Program for Elders

Primary Purpose

Depression, Anxiety, Fatigue, Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified yoga class
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Anxiety

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dominos Farms

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Modified sitting, gentle yoga class

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2020
Last Updated
April 10, 2020
Sponsor
University of Michigan
Collaborators
5 Healthy Towns Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04343625
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
5 Healthy Towns Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Fatigue, Pain, Chronic, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified sitting, gentle yoga class
Arm Type
Experimental
Arm Description
Participants attended a modified sitting gentle yoga class,10 weekly classes, each 60 minutes in duration.
Intervention Type
Behavioral
Intervention Name(s)
Modified yoga class
Intervention Description
Modified yoga was used to see if it would improve pain, fatigue, depression and anxiety, as well as improve sleep quality.
Primary Outcome Measure Information:
Title
Pain Severity
Description
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 Outcome Measure Information:
Title
Depression and anxiety as measured by The HADS scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl E LaMore, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dominos Farms
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility Study of a Modified Yoga Program for Elders

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