Expired Study
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Los Angeles, California 90095


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.


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.


Study is Available At:


Original ID:

1R01 AG030448:01A1


NCT ID:

NCT00781729


Secondary ID:


Study Acronym:


Brief Title:

Yoga for Kyphosis Trial


Official Title:

Phase 2 Study of Yoga for Excess Thoracic Curvature.


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

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


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

118


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gail A Greendale, MD
Principal Investigator
University of California, Los Angeles

Study Dates

Start Date:September 2004
Completion Date:September 2006
Completion Type:Actual
Primary Completion Date:September 2006
Primary Completion Type:Actual
Verification Date:August 2008
Last Changed Date:October 28, 2008
First Received Date:October 28, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Yoga, one hour class, 3 times per week, for 24 wee
Description:Yoga, one hour class, 3 times per week, for 24 weeks
Arm Name:1
Intervention Type:Behavioral
Name:Luncheon Seminar Series, once per month, for 24 we
Description:Luncheon Seminar Series, once per month, for 24 weeks
Arm Name:2

Study Arms

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

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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