In-home Yoga for Seniors

NCT ID: NCT05287529

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-04-30

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

Conditions

Aging Well

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

8-Week Yoga Class

Randomized to immediately begin an 8-week Yoga Class via Telehealth

Group Type: EXPERIMENTAL

Yoga Via Telehealth - Immediately

Intervention Type: BEHAVIORAL

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.

Waitlisted for 8-Week Yoga Class

Randomized to start an 8-week Yoga Class via Telehealth 8-weeks from the start of the study.

Group Type: ACTIVE_COMPARATOR

Yoga Via Telehealth - Waitlisted

Intervention Type: BEHAVIORAL

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.

Interventions

Yoga Via Telehealth - Immediately

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.

Intervention Type: BEHAVIORAL

Yoga Via Telehealth - Waitlisted

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristen Pickett, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Related Links

https://clinicaltrials.gov/ct2/show/NCT04889131

Yoga for Seniors - 12 week program

Other Identifiers

A176000

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Approved 10/20/2021

Identifier Type: OTHER

Identifier Source: secondary_id

ICTR Pilot

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021-1278

Identifier Type: -

Identifier Source: org_study_id