Yoga Empowers Seniors Study (YESS)

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01411059
First received: July 20, 2011
Last updated: August 4, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Healthy Older Adults
Behavioral: yoga

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Safe and Effective Yoga Prescription of Seniors: Biomechanical Considerations

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • peak joint moments [ Time Frame: difference from baseline to 16 wk ] [ Designated as safety issue: Yes ]
    These are the torques produced by the muscles during performance of the yoga poses

  • peak joint moments [ Time Frame: difference from 16 wk to 32 wk ] [ Designated as safety issue: Yes ]
    These are the torques produced by the muscles during performance of the yoga poses


Secondary Outcome Measures:
  • time to stand and sit from a chair 5 times [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    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.

  • number of heel-rise repetitions [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    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.

  • Time to complete Up & Go test [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of marching steps completed within 2 minutes [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    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

  • Distance participant can reach forward from a sitting position [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    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.

  • Distance between fingers of opposing hands as participant attempts to touch fingers while reaching posteriorly. [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    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.

  • Maximum passive wrist flexion, extension, radial-deviation, and ulnar-deviation, range of motion (in degrees). [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    These tests measure the range of motion of the wrist in the sagittal and frontal planes.

  • Maximum height participant can reach while standing [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    Here we quantify the maximum vertical height participants can reach while standing.

  • Maximum distance participant can reach forward while standing [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    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.

  • stride length during walking [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    Here we quantify the stride length of participants during walking at a self-selected pace.

  • Maximum joint angle [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: Yes ]
    Here we quantify the maximum joint angles of the ankle, knee, hip, trunk, shoulder, elbow, and wrist during performance of the yoga poses.

  • Sway distance of the center of pressure [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    Here we quantify the movement of the center of pressure as participants stand as still as possible

  • Electromyographic activity of muscles [ Time Frame: baseline, 16 and 32 weeks ] [ Designated as safety issue: No ]
    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.

  • SF-36 score [ Time Frame: baseline and 36 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: July 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: yoga
32 weeks of yoga training
Behavioral: yoga
yoga classes 2 times per week for 32 weeks
Other Name: activity intervention

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

    1. unable to understand their commitment to the project, (laboratory visits & regular program participation)
    2. cognitive limitations significant enough to preclude informed consent or to raise concerns about participation safety
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411059

Locations
United States, California
UCLA
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of Southern California
University of California, Los Angeles
Investigators
Principal Investigator: george salem, phd University of Southern California
  More Information

No publications provided by University of Southern California

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Salem / Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01411059     History of Changes
Other Study ID Numbers: 1R01AT004869-01
Study First Received: July 20, 2011
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
yoga biomechanics seniors

ClinicalTrials.gov processed this record on October 30, 2014