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
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Phase 2 Study of Yoga for Excess Thoracic Curvature.

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 118
Study Start Date: September 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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.

  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: NCT00781729

Locations
United States, California
UCLA Division of Geriatrics
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Investigators
Principal Investigator: Gail A Greendale, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Gail A. Greendale, MD, Geffen SOM at UCLA
ClinicalTrials.gov Identifier: NCT00781729     History of Changes
Other Study ID Numbers: 1R01 AG030448:01A1
Study First Received: October 28, 2008
Last Updated: October 28, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 26, 2014