Aging WellNCT04889131
Yoga for Seniors
A study testing Yoga Program Immediately and Activity Monitor 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 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. 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 Program Immediately and Activity Monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2019to 24 Feb 2020
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Aging Well
- Being tested
- Yoga Program Immediately, Wait-Listed Control, Activity Monitor
- Keywords
- Yoga, social isolation, underserved populations, elderly, movement, activity
- Medical subject headings
- Social Isolation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Program ImmediatelyBehavioural
free 12 week yoga program, twice a week for 75 minutes each
Wait-Listed ControlBehavioural
assigned to take the Yoga Program in 12-weeks
Activity MonitorOther
Garmin VivoSmart activity monitor throughout study
| Study group | Role | What they receive |
|---|---|---|
| Yoga Program | Experimental | 12-week yoga program begins immediately Receives: Behavioral: Yoga Program Immediately; Other: Activity Monitor |
| Wait-list Control | Active comparator | Wait-listed to take the Yoga Program in 12-weeks time Receives: Behavioral: Wait-Listed Control; Other: Activity Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
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.
Measured: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
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: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
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: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
Secondary outcomes (1)
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.
Measured: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start30 May 2019
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Why it stopped: COVID-19 vulnerable participant population
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to immediately begin a 12-week yoga class or complete a 12-week wait (wait-list control).
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Bader Philanthropies
- Responsible party
- Sponsor
- Investigators
- Kristen A Pickett, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889131
- Sponsor's protocol ID
- 2019-0479
- Other IDs
- A176000, EDUC/KINESIOLOGY
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- 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 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Seniors
- ClinicalTrials.gov ID
- NCT04889131
- Acronym / sponsor ID
- 2019-0479
- Conditions
- Aging Well
- Keywords
- Yoga, social isolation, underserved populations, elderly, movement, activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 vulnerable participant population
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Bader Philanthropies
- Study start
- 30 May 2019 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 17 May 2021 (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 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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to immediately begin a 12-week yoga class or complete a 12-week wait (wait-list control).
| Arm | Type | Receives |
|---|---|---|
| Yoga Program | Experimental | Behavioral: Yoga Program Immediately, Other: Activity Monitor12-week yoga program begins immediately |
| Wait-list Control | Active comparator | Behavioral: Wait-Listed Control, Other: Activity MonitorWait-listed to take the Yoga Program in 12-weeks time |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 Program Immediatelyfree 12 week yoga program, twice a week for 75 minutes each | Behavioural | Yoga Program |
| Wait-Listed Controlassigned to take the Yoga Program in 12-weeks | Behavioural | Wait-list Control |
| Activity MonitorGarmin VivoSmart activity monitor throughout study | Other | Wait-list Control, Yoga Program |
Primary outcome
Change in MiniBESTest Score
Time frame: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
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.
Change in Fall Frequency
Time frame: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
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.
Change in the Canadian Occupational Performance Measures (COPM)
Time frame: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
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.
Change in Activities-Specific Balance Confidence Scale (ABC)
Time frame: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
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.
1 secondary outcome
Change in Standardized Gait Analysis: Gait Velocity
Time frame: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)
Results and safety
The study was stopped early (reason given: COVID-19 vulnerable participant population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- 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 A 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 Program Immediately and Activity Monitor 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 May 2021. 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 was stopped early (reason given: COVID-19 vulnerable participant population). Results are not available in the source record.
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?
Change in MiniBESTest Score (time frame: [pre-test for waitlist group 3 months prior to class], baseline, post-test (3-months), 3-month follow up (6-months)). The study lists 4 primary outcomes in all. 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 17 May 2021.