NCT01411059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 5, 2011

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

July 20, 2011

Last Update Submit

November 14, 2016

Conditions

Keywords

yoga biomechanics seniors

Outcome Measures

Primary Outcomes (2)

  • peak joint moments

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

    difference from baseline to 16 wk

  • peak joint moments

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

    difference from 16 wk to 32 wk

Secondary Outcomes (14)

  • time to stand and sit from a chair 5 times

    baseline, 16 and 32 weeks

  • number of heel-rise repetitions

    baseline, 16 and 32 weeks

  • Time to complete Up & Go test

    baseline, 16 and 32 weeks

  • Number of marching steps completed within 2 minutes

    baseline, 16 and 32 weeks

  • Distance participant can reach forward from a sitting position

    baseline, 16 and 32 weeks

  • +9 more secondary outcomes

Study Arms (1)

yoga

EXPERIMENTAL

32 weeks of yoga training

Behavioral: yoga

Interventions

yogaBEHAVIORAL

yoga classes 2 times per week for 32 weeks

Also known as: activity intervention
yoga

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90024, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • george salem, phd

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 20, 2011

First Posted

August 5, 2011

Study Start

July 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations