Clinical trial NCT05287529: In-home Yoga for Seniors
Official title: Telehealth Delivery of the Yoga for Seniors Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Well
Keywords: underserved populations
yoga
elderly
movement
activity
balance
social isolation
falls
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall purpose of this study is to adapt a 12-week, standardized in-home yoga program into an 8-week in-home program with a high degree of fidelity, participant adherence, and safety. The Yoga for Seniors program was previously implemented in five rural WI communities with five yoga teachers providing the in-class guidance and support for the standardized program. The investigators seek to convert the program to a telehealth-based approach and deliver the intervention with fidelity to the program, in a safe and effective manner to 120 participants.

Detailed description: Participants will be randomly assigned to immediately begin an 8-week yoga class or complete an 8-week wait (wait-list control). Investigators will examine the measures of interest at pretest (wait-list only), baseline, and posttest to see what, if any, changes are observed after completion of the program. All assessment data collections sessions will be conducted on-line.

Phone screen: All interested participants will complete a phone screen to assess inclusion and exclusion factor for the study.

Testing Procedures: All participants who meet study requirements will complete approximately 60 to 90 minutes of on-line assessments and 60-90 minutes of mailed questionnaires at each testing timepoint (pretest, baseline, and posttest). The assessments will consist of demographic information including a health history form, a semi-structured interview, and a series of questionnaires. The following are the specific assessment components for each time point:

A. Intake and review of forms (Initial Visit (Baseline or Pretest ))

1. Consent form
2. Medical history

B. Clinical measures (all visits)

1. Current medication list
2. Falls history and fear of falls questionnaire
3. Canadian Occupational Performance Measure
4. Physical Activity Scale
5. Perceived Stress Scale
6. Loneliness and Social Isolation Scales
7. Social Network Scale

C. Barriers and facilitators assessments (all visits)

1. technology use assessment survey
2. physical activity readiness scale

D. Exit evaluation (posttest only)

All selected assessment tools have been previously investigated and are valid and reliable for their described use.

During the initial visit (pretest or baseline), participants will complete components A-C listed above.

Individuals in the wait-list control group will complete components B and C during their baseline visit (prior to starting yoga, following their 8-week wait)

Posttest assessment Components B-D will be completed at posttest. Posttest data will be collected within 10 days of the participant's last day of the yoga class.

The group that starts immediately will have 2 time-points of data collection (pretest, posttest), the waitlisted group will have 3 time-points of data collection (baseline, pretest, posttest). Individual results will not be shown or discussed with participants.

The yoga program is an in-home, chair-assisted yoga class focused on balance. Each class will be led by a certified yoga teacher who has completed training the the yoga for Seniors Program. Classes will consist of no more than 12 participants. Each class will be attended by a local community member who will facilitate community building before and after class and will be available to activate local emergency medical services in the unlikely event that the need arises. Classes are 75 minutes in duration and meet two times per week.

See also 12-week program called Yoga for Seniors registered to NCT04889131

Eligibility criteria: Inclusion Criteria:

* over 60 years of age
* 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 8 weeks
* a previous fall, near-fall or identified fear of falling
* internet access
* vision at or corrected to 20/40 or better

Exclusion Criteria:

* known contraindication for exercise (i.e. a medical doctor has told you not to exercise)

Primary outcomes:
measure: Percentage of Classes Attended (?0
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Change in Fall Frequency
timeFrame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
measure: Change in Activities-Specific Balance Confidence Scale (ABC)
timeFrame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
measure: Change in Mobility Scale Score
timeFrame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
measure: Change in the Canadian Occupational Performance Measures (COPM)
timeFrame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
measure: Change in Physical Activity Scale Score
timeFrame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
measure: Change in Perceived Stress Scale Score
timeFrame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
measure: Loneliness and Social Isolation Scale Score
timeFrame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
measure: Social Network Scale Score
timeFrame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kristen Pickett, PhD
role: PRINCIPAL_INVESTIGATOR
References: