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Yoga for Kyphosis Trial

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ClinicalTrials.gov Identifier: NCT00781729
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : October 29, 2008
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
This study seeks to determine whether a specially designed Hatha Yoga program can reduce hyperkyphosis in men and women who are at least 60 years of age and who have excessive thoracic kyphosis.

Condition or disease Intervention/treatment Phase
Kyphosis Behavioral: Yoga, one hour class, 3 times per week, for 24 weeks Behavioral: Luncheon Seminar Series, once per month, for 24 weeks Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Phase 2 Study of Yoga for Excess Thoracic Curvature.
Study Start Date : September 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Arm Intervention/treatment
Experimental: 1
Yoga, one hour class, 3 times per week, for 24 weeks
Behavioral: Yoga, one hour class, 3 times per week, for 24 weeks
Yoga, one hour class, 3 times per week, for 24 weeks
Placebo Comparator: 2
Luncheon Seminar Series, once per month, for 24 weeks
Behavioral: Luncheon Seminar Series, once per month, for 24 weeks
Luncheon Seminar Series, once per month, for 24 weeks



Primary Outcome Measures :
  1. The primary outcomes were change in the following: Debrunner kyphometer-assessed kyphosis angle, standing height, timed chair stands, functional reach and walking speed. [ Time Frame: Baseline to 6 months ]

Secondary Outcome Measures :
  1. Secondary outcomes were change in: kyphosis index, flexicurve kyphosis angle, Rancho Bernardo Blocks, pulmonary function and several domains of health-related quality of life (HRQOL). [ Time Frame: Baseline to 6 months ]


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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 60 years or greater
  • willingness to accept randomization
  • adult-onset hyperkyphosis (noticed after age 50)
  • measured Debrunner kyphometer angle >40 degrees

Exclusion Criteria:

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); current unstable asthma or exacerbated chronic obstructive pulmonary disease; cervical spine instability; unstable knee or shoulder joints; hemiparesis or paraparesis; use of assistive walking device or wheelchair; unable to hear or see adequately for participation in Yoga classes; unable to comprehend and follow directions (in English); unable to attend in-person classes; likely to move within the year after screening; has not had check-up by health care provider within 12 months (if not taking any prescription medications) or in the past 6 months (if any regular medicines taken) and is not willing to do so prior to enrollment; cannot pass physical safety tests. Physical safety was assessed as the ability to stably execute each of the following movements without human assistance: transition from standing to recumbent on the floor and get up from the floor to standing; lift both arms to shoulder level without losing balance; stand with feet side-by-side for 30 seconds; and stand with feet hip-width apart for 60 seconds.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781729


Locations
United States, California
UCLA Division of Geriatrics
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Aging (NIA)
Investigators
Principal Investigator: Gail A Greendale, MD University of California, Los Angeles

Responsible Party: Gail A. Greendale, MD, Geffen SOM at UCLA
ClinicalTrials.gov Identifier: NCT00781729     History of Changes
Other Study ID Numbers: 1R01AG030448-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: August 2008

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Kyphosis
Yoga
Aging
Physical performance
Quality of Life

Additional relevant MeSH terms:
Kyphosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases