Yoga for Seniors

Aging Well Clinical Trial

Official title:

Yoga for Seniors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04889131
• Other study ID #: 2019-0479
• Secondary ID: A176000EDUC/KINE
• Status: Terminated
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: February 24, 2020

Study information

• Verified date: May 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participants will be assigned to immediately begin a 12-week yoga class (2 classes per week for 75 minutes each) or complete a 12-week wait (wait-list control). The measures of interest will be examined at pretest (wait-list only), baseline, posttest and at 3-month follow-up to see what, if any, changes are maintained after completion of the program. All assessment data collections sessions will be conducted on-site at a predetermined site identified by the community partners.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: February 24, 2020
• Est. primary completion date: February 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aging Well

Intervention

Behavioral:
• Yoga Program Immediately
free 12 week yoga program, twice a week for 75 minutes each
• Wait-Listed Control
assigned to take the Yoga Program in 12-weeks

Other:
• Activity Monitor
Garmin VivoSmart activity monitor throughout study

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Bader Philanthropies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Activity Level Measured by Number of Steps Taken	Participants will be fitted with a Garmin VivoSmart activity monitor and will be asked to wear the device for the duration of the study.	[pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
Other	Change in Performance Assessment of Self-Care Skills (PASS)	The Performance Assessment of Self-Care Skills (PASS) assesses basic self-care and instrumental activities of daily living. Subscales: Independence, Safety, and Adequacy (0-3 where higher scores indicate less difficulty with basic self-care).	[pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Change in Standardized Gait Analysis: Gait Velocity	Using the GaitRite® System, the temporal and spatial parameters of each participant will be captured during walking. The GaitRite® mat is a 14 foot portable electronic walkway, embedded with sensors to enable the measurement spatiotemporal variables of gait such as cadence, normalized velocity, stride length, base of support, and percent of cycle in double support. Participants will begin at a starting point two meters from the mat, then walk toward and step onto the mat to continue walking until they achieve the stop line located two meters off of the opposite side of the mat. Data will be collected for forward preferred speed, backward preferred speed, forward fast, tandem and dual task gait. Each participant will complete five trials for each condition.	[pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)