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Healthy Older AdultsYESSNCT01411059

Yoga Empowers Seniors Study

A study testing yoga in people with Healthy Older Adults, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an Intervention Development Study (IDS) to quantify the physical demands (using biomechanical investigation) of a 2-phase (beginning \& intermediate), 32-week yoga program designed for community-dwelling older adults. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Older Adults
What is being tested?
yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
Jul 2009to Apr 2011
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Community dwelling men and women volunteers, aged 65 years or older.

Who cannot join

  • Safety exclusions:
  • --the following safety exclusions are adopted in order to decrease potential cardiovascular
  • musculoskeletal
  • neurological risks to the participants:
  • active angina
  • uncontrolled hypertension (SBP greater than 160 or DBP greater than 90)
Show all 20Show fewer
  • high resting pulse or respiratory rate (HR >90 or RR>24 after 5 minutes seated)
  • unstable asthma or exacerbated COPD
  • cervical spine instability or other significant neck injury
  • rheumatoid arthritis
  • unstable ankle, knee, hip, shoulder, elbow, or wrist joints
  • hemiparesis or paraparesis
  • movement disorders (e.g. Parkinson's disease), peripheral neuropathies, stroke with residual deficits, severe vision or hearing problems
  • walker or wheelchair use
  • insufficient hearing to permit safety in a yoga group setting
  • not able to attend in-person classes
  • has not had check-up by regular provider within 12 months (if not taking any prescription medications) or in the past 6 months (if any regular medicines taken); cannot pass specific movement safety tests (tests described in section on screening visits, below)
  • Feasibility/adherence exclusions:
  • unable to understand their commitment to the project, (laboratory visits \& regular program participation)
  • cognitive limitations significant enough to preclude informed consent or to raise concerns about participation safety

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA

    Los Angeles, California, 90024

Other trials in United States

About this study

Official title: Safe and Effective Yoga Prescription of Seniors: Biomechanical Considerations

This is an Intervention Development Study (IDS) to quantify the physical demands (using biomechanical investigation) of a 2-phase (beginning \& intermediate), 32-week yoga program designed for community-dwelling older adults. Additionally, the IDS will explore the adherence and adverse events of participation in the program. Data from the IDS will be used to develop evidenced-based yoga programs, which the investigators postulate will be associated with fewer musculoskeletal side effects compared to non-evidence based yoga programs. The investigators also postulate that evidenced-based tailoring of yoga for seniors will enhance adherence and efficacy. The programs developed during this IDS will be tested in an expanded, Phase II, Randomized Controlled Trial.

Read the detailed description

Yoga is currently being recommended to restore and preserve strength, flexibility, balance, \& physical capacity in older adults; however, our clinical trial experiences suggest that without proper evidenced-based prescription, Yoga participation can be ineffective or even injurious for seniors. To address this lack of evidence-based knowledge, the proposed IDS will: 1) quantify the physical demands of a 32-wk Yoga program designed for independent ambulatory seniors; 2) characterize the relations between these demands and participant physical characteristics; 3) examine the adherence, efficacy, \& safety of the program; and 4) characterize the relations among reported adverse events, baseline participant characteristics, and Yoga physical demands.

Being tested
yoga
Keywords
yoga biomechanics seniors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • yogaBehavioural

    Also called activity intervention

    yoga classes 2 times per week for 32 weeks

Study groups in NCT01411059
Study groupRoleWhat they receive
yogaExperimental32 weeks of yoga training
Receives: Behavioral: yoga

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. peak joint moments

    These are the torques produced by the muscles during performance of the yoga poses

    Measured: difference from baseline to 16 wk

  2. peak joint moments

    These are the torques produced by the muscles during performance of the yoga poses

    Measured: difference from 16 wk to 32 wk

Secondary outcomes (14)

  1. time to stand and sit from a chair 5 times

    In the 5-Repetition Chair Stand Test, we record the time it takes for a participant to repeatedly stand and sit on a chair 5 times.

    Measured: baseline, 16 and 32 weeks

  2. number of heel-rise repetitions

    The Heel-Rise Test is a measure of plantar-flexion endurance. Here, we record the number of full range-of-motion, heel-rise repetitions the participants can complete before fatigue.

    Measured: baseline, 16 and 32 weeks

  3. Time to complete Up & Go test

    In the Up \& Go Test, a measure of mobility, we record the number of seconds it takes to rise from a chair, walk 8 feet, return and sit in the chair.

    Measured: baseline, 16 and 32 weeks

  4. Number of marching steps completed within 2 minutes

    In the 2-Minute Step Test, a measure stepping endurance, we record the number of complete marching steps the participant can perform within a 2-minute period

    Measured: baseline, 16 and 32 weeks

  5. Distance participant can reach forward from a sitting position

    The sit and reach test measures overall sagittal-plane flexibility. The participant is asked to reach as far as possible toward their dominant limb while remaining seated.

    Measured: baseline, 16 and 32 weeks

  6. Distance between fingers of opposing hands as participant attempts to touch fingers while reaching posteriorly.

    The Back Scratch Test measures upper extremity flexibility. Here the distance between finger-tips is recorded as the participant reaches posteriorly and attempts to touch opposing hands.

    Measured: baseline, 16 and 32 weeks

  7. Maximum passive wrist flexion, extension, radial-deviation, and ulnar-deviation, range of motion (in degrees).

    These tests measure the range of motion of the wrist in the sagittal and frontal planes.

    Measured: baseline, 16 and 32 weeks

  8. Maximum height participant can reach while standing

    Here we quantify the maximum vertical height participants can reach while standing.

    Measured: baseline, 16 and 32 weeks

  9. Maximum distance participant can reach forward while standing

    THe Maximum Forward Reach test is a measure of strength and flexibility. Here we record the maximum distance the participant can reach forward while standing.

    Measured: baseline, 16 and 32 weeks

  10. stride length during walking

    Here we quantify the stride length of participants during walking at a self-selected pace.

    Measured: baseline, 16 and 32 weeks

  11. Maximum joint angle

    Here we quantify the maximum joint angles of the ankle, knee, hip, trunk, shoulder, elbow, and wrist during performance of the yoga poses.

    Measured: baseline, 16 and 32 weeks

  12. Sway distance of the center of pressure

    Here we quantify the movement of the center of pressure as participants stand as still as possible

    Measured: baseline, 16 and 32 weeks

  13. Electromyographic activity of muscles

    Here we record the electromyographic activity of the Anterior Deltoid, Triceps surae, Obliques, Rectus Abdominus, Erector Spinae, Gluteus Maximus, Lateral Hamstrings, Vastus Lateralis, Gastrocnemius, and Gluteus Medius, muscles during performance of the yoga poses.

    Measured: baseline, 16 and 32 weeks

  14. SF-36 score

    Health related quality of life and mood will be assessed with the RAND Short Form-36 (Hays, 1993). The SF-36 includes sub-scales that measure: 1) health-related limitations in physical function; 2) health-related limitations in role and in social function; 3) emotional function (including positive and negative mood states); 4) pain.

    Measured: baseline and 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2011 (estimated)
  2. Study startJul 2009
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

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
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01411059
Sponsor's protocol ID
1R01AT004869-01
Acronym
YESS
Status last verified
Nov 2016
First submitted
20 Jul 2011
Last updated
16 Nov 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang MY, Yu SS, Hashish R, Samarawickrame SD, Kazadi L, Greendale GA, Salem G. The biomechanical demands of standing yoga poses in seniors: The Yoga empowers seniors study (YESS). BMC Complement Altern Med. 2013 Jan 9;13:8. doi: 10.1186/1472-6882-13-8.

    PubMed 23302513

Questions about this trial

What is this clinical trial studying?

A study testing yoga in people with Healthy Older Adults, run by University of Southern California 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 1 inclusion and 20 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 16 Nov 2016. 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?

peak joint moments (time frame: difference from baseline to 16 wk). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01411059, which also lists 1 linked publication.

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 16 Nov 2016.

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