Clinical trial NCT01411059: Yoga Empowers Seniors Study
Official title: Safe and Effective Yoga Prescription of Seniors: Biomechanical Considerations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Older Adults
Keywords: yoga biomechanics seniors
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2011-08-05
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

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 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

Primary outcomes:
measure: peak joint moments
timeFrame: difference from baseline to 16 wk
measure: peak joint moments
timeFrame: difference from 16 wk to 32 wk
Secondary outcomes:
measure: time to stand and sit from a chair 5 times
timeFrame: baseline, 16 and 32 weeks
measure: number of heel-rise repetitions
timeFrame: baseline, 16 and 32 weeks
measure: Time to complete Up & Go test
timeFrame: baseline, 16 and 32 weeks
measure: Number of marching steps completed within 2 minutes
timeFrame: baseline, 16 and 32 weeks
measure: Distance participant can reach forward from a sitting position
timeFrame: baseline, 16 and 32 weeks
measure: Distance between fingers of opposing hands as participant attempts to touch fingers while reaching posteriorly.
timeFrame: baseline, 16 and 32 weeks
measure: Maximum passive wrist flexion, extension, radial-deviation, and ulnar-deviation, range of motion (in degrees).
timeFrame: baseline, 16 and 32 weeks
measure: Maximum height participant can reach while standing
timeFrame: baseline, 16 and 32 weeks
measure: Maximum distance participant can reach forward while standing
timeFrame: baseline, 16 and 32 weeks
measure: stride length during walking
timeFrame: baseline, 16 and 32 weeks
measure: Maximum joint angle
timeFrame: baseline, 16 and 32 weeks
measure: Sway distance of the center of pressure
timeFrame: baseline, 16 and 32 weeks
measure: Electromyographic activity of muscles
timeFrame: baseline, 16 and 32 weeks
measure: SF-36 score
timeFrame: baseline and 36 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of Southern California
name: george salem, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.