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Yoga for Kyphosis Trial

Primary Purpose

Kyphosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Yoga, one hour class, 3 times per week, for 24 weeks

Luncheon Seminar Series, once per month, for 24 weeks

About this trial

This is an interventional treatment trial for Kyphosis focused on measuring Kyphosis, Yoga, Aging, Physical performance, Quality of Life

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

UCLA Division of Geriatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Yoga, one hour class, 3 times per week, for 24 weeks

Luncheon Seminar Series, once per month, for 24 weeks

Outcomes

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.

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).

Full Information

NCT ID

NCT00781729

First Posted

October 28, 2008

Last Updated

October 28, 2008

Sponsor

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

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT00781729

Brief Title

Yoga for Kyphosis Trial

Official Title

Phase 2 Study of Yoga for Excess Thoracic Curvature.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

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

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kyphosis

Keywords

Kyphosis, Yoga, Aging, Physical performance, Quality of Life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Yoga, one hour class, 3 times per week, for 24 weeks

Arm Title

Arm Type

Placebo Comparator

Arm Description

Luncheon Seminar Series, once per month, for 24 weeks

Intervention Type

Behavioral

Intervention Name(s)

Yoga, one hour class, 3 times per week, for 24 weeks

Intervention Description

Yoga, one hour class, 3 times per week, for 24 weeks

Intervention Type

Behavioral

Intervention Name(s)

Luncheon Seminar Series, once per month, for 24 weeks

Intervention Description

Luncheon Seminar Series, once per month, for 24 weeks

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gail A Greendale, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA Division of Geriatrics

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

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