NCT05287529

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

March 9, 2022

Last Update Submit

November 8, 2022

Conditions

Keywords

underserved populationsyogaelderlymovementactivitybalancesocial isolationfalls

Outcome Measures

Primary Outcomes (1)

  • Percentage of Classes Attended (?0

    Participant adherence will be measured in part by class attendance. They will have twice weekly classes for 8 weeks, or 16 possible classes to attend. \[from the purpose: The overall purpose of this study is to adapt the 12-week, standardized in-home yoga program into an 8-week in-home program with a high degree of fidelity, participant adherence, and safety. Are fidelity/adherence/safety a primary outcomes?\]

    up to 8 weeks

Secondary Outcomes (8)

  • Change in Fall Frequency

    baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)

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

    baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)

  • Change in Mobility Scale Score

    baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)

  • Change in the Canadian Occupational Performance Measures (COPM)

    baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)

  • Change in Physical Activity Scale Score

    baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)

  • +3 more secondary outcomes

Study Arms (2)

8-Week Yoga Class

EXPERIMENTAL

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

Behavioral: Yoga Via Telehealth - Immediately

Waitlisted for 8-Week Yoga Class

ACTIVE COMPARATOR

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

Behavioral: Yoga Via Telehealth - Waitlisted

Interventions

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.

8-Week Yoga Class

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

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Links

MeSH Terms

Conditions

Motor ActivitySocial Isolation

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Officials

  • Kristen Pickett, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 18, 2022

Study Start

December 1, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations