NCT00781729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
Last Updated

October 29, 2008

Status Verified

August 1, 2008

Enrollment Period

2 years

First QC Date

October 28, 2008

Last Update Submit

October 28, 2008

Conditions

Kyphosis

Keywords

KyphosisYogaAgingPhysical performanceQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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

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

2

PLACEBO COMPARATOR

Luncheon Seminar Series, once per month, for 24 weeks

Behavioral: Luncheon Seminar Series, once per month, for 24 weeks

Interventions

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

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

1
Luncheon Seminar Series, once per month, for 24 weeksBEHAVIORAL

Luncheon Seminar Series, once per month, for 24 weeks

2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 60 years or greater
  • willingness to accept randomization
  • adult-onset hyperkyphosis (noticed after age 50)
  • measured Debrunner kyphometer angle \>40 degrees

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Division of Geriatrics

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Kyphosis

Interventions

YogaArtifactsWW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesInvestigative TechniquesShort Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Gail A Greendale, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 29, 2008

Study Start

September 1, 2004

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

October 29, 2008

Record last verified: 2008-08

Locations

US(1)