NCT04889131

Brief Summary

The overall purpose of this study is to deliver a 12-week yoga program to older adults (over 60 years of age) in rural WI who do not have access to yoga programming and examine the effects of the programming on activities of daily living, gait, balance, falls, activity level and social isolation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 30, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

May 12, 2021

Last Update Submit

May 12, 2021

Conditions

Keywords

Yogasocial isolationunderserved populationselderlymovementactivity

Outcome Measures

Primary Outcomes (4)

  • Change in MiniBESTest Score

    The mini-BESTest will be used to assess balance. This 14-item, clinical battery is used to assess balance in four component areas (anticipatory transitions, postural response, sensory orientation and dynamic gait) and provides a single number summary of balance performance. Scores range from 0 to 28, with higher scores indicating higher function.

    [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)

  • Change in Fall Frequency

    Change in the frequency of falls will be assessed using a forced-choice paradigm: none, once, 2 to 10 times, weekly, or daily over the last 6 months.

    [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)

  • Change in the Canadian Occupational Performance Measures (COPM)

    The COPM is composed of the following steps: 1) participant identifies occupational performance problems for self-care and productivity, 2) participant rates each issue on a score of 1-10 (higher scores are more important), 3) participant chooses 5 most important problems, 4) participant rates each issue (1-10) for performance and satisfaction, 5) average score for each (performance and satisfaction) are calculated. Final score for each is 1-10 with higher scores better.

    [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)

  • Change in Activities-Specific Balance Confidence Scale (ABC)

    The ABC Scale measures a fear of falling. It is a 16-item survey where participants rate their level of self-confidence (0-100, where 100 is the highest self-confidence) for each item. The average score is reported.

    [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)

Secondary Outcomes (1)

  • Change in Standardized Gait Analysis: Gait Velocity

    [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)

Other Outcomes (2)

  • Change in Activity Level Measured by Number of Steps Taken

    [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)

  • Change in Performance Assessment of Self-Care Skills (PASS)

    [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)

Study Arms (2)

Yoga Program

EXPERIMENTAL

12-week yoga program begins immediately

Behavioral: Yoga Program ImmediatelyOther: Activity Monitor

Wait-list Control

ACTIVE COMPARATOR

Wait-listed to take the Yoga Program in 12-weeks time

Behavioral: Wait-Listed ControlOther: Activity Monitor

Interventions

free 12 week yoga program, twice a week for 75 minutes each

Yoga Program

assigned to take the Yoga Program in 12-weeks

Wait-list Control

Garmin VivoSmart activity monitor throughout study

Wait-list ControlYoga Program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to independently ambulate for at least 10 minutes continuously (with or without an assistive device)
  • Ability to attend the yoga class for all or most of the 12 weeks
  • A previous fall, near-fall or identified fear of falling

You may not qualify if:

  • No known contraindication for exercise (i.e. a medical doctor has told you not to exercise)
  • A resent injury that causes pain during movement
  • Current enrollment in another research study or class focused on balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Social IsolationMotor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Kristen A Pickett, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be assigned to immediately begin a 12-week yoga class or complete a 12-week wait (wait-list control).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 17, 2021

Study Start

May 30, 2019

Primary Completion

February 24, 2020

Study Completion

February 24, 2020

Last Updated

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations