Phase 2 Study of Yoga for Excess Thoracic Curvature.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)1 site in 1 country118 target enrollmentSeptember 2004

ConditionsKyphosis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Kyphosis
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Enrollment: 118
Locations: 1
Primary Endpoint: The primary outcomes were change in the following: Debrunner kyphometer-assessed kyphosis angle, standing height, timed chair stands, functional reach and walking speed.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

September 2006

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility 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.

Outcomes

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.

Time Frame: 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)