Yoga for Kyphosis Trial

NCT00781729 — Phase 2, Completed, 118 participants, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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Phase 2 Study of Yoga for Excess Thoracic Curvature.

Registry	NCT00781729
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	118 (Actual)
Sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (Nih); collaborators: National Institute on Aging (NIA)
Conditions	Kyphosis
Interventions	Yoga, one hour class, 3 times per week, for 24 weeks, Luncheon Seminar Series, once per month, for 24 weeks (Behavioral)
Dates	start 2004-09-01, primary completion 2006-09-01, completion 2006-09-01, first posted 2008-10-29, last updated 2008-10-29
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Behavioral: Yoga, one hour class, 3 times per week, for 24 weeks	Yoga, one hour class, 3 times per week, for 24 weeks
2	Placebo comparator	Behavioral: Luncheon Seminar Series, once per month, for 24 weeks	Luncheon Seminar Series, once per month, for 24 weeks

Yoga, one hour class, 3 times per week, for 24 weeks (Behavioral): Yoga, one hour class, 3 times per week, for 24 weeks
Luncheon Seminar Series, once per month, for 24 weeks (Behavioral): Luncheon Seminar Series, once per month, for 24 weeks

+Outcome measures

Primary outcomes

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

Secondary outcomes

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). [Baseline to 6 months]

+Eligibility

Sex: All, ages: 60 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
UCLA Division of Geriatrics	Los Angeles, California	United States

+Investigators

Gail A Greendale, MD, Principal investigator, University of California, Los Angeles