NCT04343625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

April 9, 2020

Last Update Submit

April 10, 2020

Conditions

Outcome Measures

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.

    20 weeks

Secondary Outcomes (1)

  • Depression and anxiety as measured by The HADS scale

    20 weeks

Study Arms (1)

Modified sitting, gentle yoga class

EXPERIMENTAL

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

Behavioral: Modified yoga class

Interventions

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

Modified sitting, gentle yoga class

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dominos Farms

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersFatigueChronic Pain

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic Manifestations

Study Officials

  • Cheryl E LaMore, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 13, 2020

Study Start

May 23, 2018

Primary Completion

August 8, 2019

Study Completion

August 8, 2019

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations