Feasibility Study of a Modified Yoga Program for Elders

NCT ID: NCT04343625

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-23
• Study Completion Date: 2019-08-08

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.

Conditions

Depression, Anxiety; Fatigue; Pain, Chronic; Sleep

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified sitting, gentle yoga class

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

Group Type: EXPERIMENTAL

Modified yoga class

Intervention Type: BEHAVIORAL

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

Interventions

Modified yoga class

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

5 Healthy Towns Foundation

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Cheryl LaMore

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheryl E LaMore, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Dominos Farms

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00128999

Identifier Type: -

Identifier Source: org_study_id