Yoga for Kyphosis Trial

Kyphosis Clinical Trial

Official title:

Phase 2 Study of Yoga for Excess Thoracic Curvature.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781729
• Other study ID #: 1R01AG030448-01A1
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2008
• Last updated: October 28, 2008
• Start date: September 2004
• Est. completion date: September 2006

Study information

• Verified date: August 2008
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kyphosis

Intervention

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

Locations

Country	Name	City	State
United States	UCLA Division of Geriatrics	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No