Aging WellNCT05287529
In-home Yoga for Seniors
A study testing Yoga Via Telehealth - Immediately and Yoga Via Telehealth - Waitlisted in people with Aging Well, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Well
- What is being tested?
- Yoga Via Telehealth - Immediately and Yoga Via Telehealth - Waitlisted
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- known contraindication for exercise (i.e. a medical doctor has told you not to exercise)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telehealth Delivery of the Yoga for Seniors Program
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.
Read the 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:
- Intake and review of forms (Initial Visit (Baseline or Pretest ))
- Consent form
- Medical history
- Clinical measures (all visits)
- Current medication list
- Falls history and fear of falls questionnaire
- Canadian Occupational Performance Measure
- Physical Activity Scale
- Perceived Stress Scale
- Loneliness and Social Isolation Scales
- Social Network Scale
- Barriers and facilitators assessments (all visits)
- technology use assessment survey
- physical activity readiness scale
- 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
- Being tested
- Yoga Via Telehealth - Immediately, Yoga Via Telehealth - Waitlisted
- Keywords
- underserved populations, yoga, elderly, movement, activity, balance, social isolation, falls
- Medical subject headings
- Motor Activity, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Via Telehealth - ImmediatelyBehavioural
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.
Yoga Via Telehealth - WaitlistedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 8-Week Yoga Class | Experimental | Randomized to immediately begin an 8-week Yoga Class via Telehealth Receives: 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. Receives: Behavioral: Yoga Via Telehealth - Waitlisted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?]
Measured: up to 8 weeks
Secondary outcomes (8)
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 2 weeks, 1 month, and 6 months.
Measured: 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)
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.
Measured: 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
Participant is asked to rate their level of confidence (1 extreme confidence to - 10 no confidence at all) that they will not fall in each of 10 activities. Mean confidence level is calculated, lower scores indicate increased confidence.
Measured: 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)
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.
Measured: 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
12 items scored on a 4 point likert scale for a total possible range of scores from 0-36 where higher scores indicate more physical activity.
Measured: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
Change in Perceived Stress Scale Score
10 items scored on a 5 point likert scale for a total possible range of scores from 0-40 where higher scores indicate increased perceived stress.
Measured: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
Loneliness and Social Isolation Scale Score
26 items scored on a 4 point likert scale for a total possible range of scores from 0-96 where higher scores indicate increased feelings of loneliness and social isolation.
Measured: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
Social Network Scale Score
6 items scored on a 6 point likert scale for a total possible range of scores from 0-30 where higher scores indicate larger social network.
Measured: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Dec 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen Pickett, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287529
- Sponsor's protocol ID
- 2021-1278
- Other IDs
- A176000, Protocol Approved 10/20/2021, ICTR Pilot
- Status last verified
- Nov 2022
- First submitted
- 9 Mar 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Delivery of the Yoga for Seniors Program
- ClinicalTrials.gov ID
- NCT05287529
- Acronym / sponsor ID
- 2021-1278
- Conditions
- Aging Well
- Keywords
- underserved populations, yoga, elderly, movement, activity, balance, social isolation, falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Intake and review of forms (Initial Visit (Baseline or Pretest ))
- Consent form
- Medical history
- Clinical measures (all visits)
- Current medication list
- Falls history and fear of falls questionnaire
- Canadian Occupational Performance Measure
- Physical Activity Scale
- Perceived Stress Scale
- Loneliness and Social Isolation Scales
- Social Network Scale
- Barriers and facilitators assessments (all visits)
- technology use assessment survey
- physical activity readiness scale
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8-Week Yoga Class | Experimental | Behavioral: Yoga Via Telehealth - ImmediatelyRandomized to immediately begin an 8-week Yoga Class via Telehealth |
| Waitlisted for 8-Week Yoga Class | Active comparator | Behavioral: Yoga Via Telehealth - WaitlistedRandomized to start an 8-week Yoga Class via Telehealth 8-weeks from the start of the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- known contraindication for exercise (i.e. a medical doctor has told you not to exercise)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Via Telehealth - ImmediatelyThe 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. | Behavioural | 8-Week Yoga Class |
| Yoga Via Telehealth - WaitlistedThe 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. | Behavioural | Waitlisted for 8-Week Yoga Class |
Primary outcome
Percentage of Classes Attended (?0
Time frame: up to 8 weeks
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?]
8 secondary outcomes
Change in Fall Frequency
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
Change in Perceived Stress Scale Score
Time frame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
Loneliness and Social Isolation Scale Score
Time frame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
Social Network Scale Score
Time frame: baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Yoga for Seniors - 12 week programLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Pickett, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Via Telehealth - Immediately and Yoga Via Telehealth - Waitlisted in people with Aging Well, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Classes Attended (?0 (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.