Yoga for Kyphosis Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00781729
First received: October 28, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted

October 28, 2008
October 28, 2008
September 2004
September 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Yoga for Kyphosis Trial
Phase 2 Study of Yoga for Excess Thoracic Curvature.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Kyphosis
  • Behavioral: Yoga, one hour class, 3 times per week, for 24 weeks
    Yoga, one hour class, 3 times per week, for 24 weeks
  • Behavioral: Luncheon Seminar Series, once per month, for 24 weeks
    Luncheon Seminar Series, once per month, for 24 weeks
  • Experimental: 1
    Yoga, one hour class, 3 times per week, for 24 weeks
    Intervention: Behavioral: Yoga, one hour class, 3 times per week, for 24 weeks
  • Placebo Comparator: 2
    Luncheon Seminar Series, once per month, for 24 weeks
    Intervention: Behavioral: Luncheon Seminar Series, once per month, for 24 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
September 2006
September 2006   (final data collection date for primary outcome measure)

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.

Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00781729
1R01 AG030448:01A1
Yes
Gail A. Greendale, MD, Geffen SOM at UCLA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Aging (NIA)
Principal Investigator: Gail A Greendale, MD University of California, Los Angeles
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP