Yoga for Kyphosis Trial

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Study of Yoga for Excess Thoracic Curvature.

Conditions
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Kyphosis

Intervention / Treatment
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* Behavioral: Yoga, one hour class, 3 times per week, for 24 weeks
* Behavioral: Luncheon Seminar Series, once per month, for 24 weeks


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Yoga, one hour class, 3 times per week, for 24 weeks | Behavioral: Yoga, one hour class, 3 times per week, for 24 weeks<br>* Yoga, one hour class, 3 times per week, for 24 weeks<br>|
| Placebo Comparator: 2<br>Luncheon Seminar Series, once per month, for 24 weeks | Behavioral: Luncheon Seminar Series, once per month, for 24 weeks<br>* Luncheon Seminar Series, once per month, for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kyphosis, Yoga, Aging, Physical performance, Quality of Life