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Completed

NCT Number: NCT01411059

Yoga Empowers Seniors Study

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.

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Key information

Conditions

Healthy Older Adults

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA

Los Angeles, California, 90024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Yoga

Behavioral

yoga classes 2 times per week for 32 weeks

Other names: activity intervention

Primary outcomes

  1. peak joint moments

    Time frame: difference from baseline to 16 wk

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

  2. peak joint moments

    Time frame: difference from 16 wk to 32 wk

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

Secondary outcomes

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

    Time frame: baseline, 16 and 32 weeks

    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.

  2. number of heel-rise repetitions

    Time frame: baseline, 16 and 32 weeks

    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.

  3. Time to complete Up & Go test

    Time frame: baseline, 16 and 32 weeks

    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.

  4. Number of marching steps completed within 2 minutes

    Time frame: baseline, 16 and 32 weeks

    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

  5. Distance participant can reach forward from a sitting position

    Time frame: baseline, 16 and 32 weeks

    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.

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

    Time frame: baseline, 16 and 32 weeks

    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.

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

    Time frame: baseline, 16 and 32 weeks

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

  8. Maximum height participant can reach while standing

    Time frame: baseline, 16 and 32 weeks

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

  9. Maximum distance participant can reach forward while standing

    Time frame: baseline, 16 and 32 weeks

    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.

  10. stride length during walking

    Time frame: baseline, 16 and 32 weeks

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

  11. Maximum joint angle

    Time frame: baseline, 16 and 32 weeks

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

  12. Sway distance of the center of pressure

    Time frame: baseline, 16 and 32 weeks

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

  13. Electromyographic activity of muscles

    Time frame: baseline, 16 and 32 weeks

    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.

  14. SF-36 score

    Time frame: baseline and 36 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • University of California, Los Angeles

Registry information

Official study title

Safe and Effective Yoga Prescription of Seniors: Biomechanical Considerations

Acronym: YESS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 5, 2011
Registry last updated
Nov 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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