Yoga to Prevent Mobility Limitations in Older Adults

Study Overview
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Brief Summary
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The loss of mobility during aging impacts independence and leads to further disability, morbidity, and reduced life expectancy. The study objective was to examine the feasibility and safety of conducting a randomized controlled trial of yoga for older adults at risk for mobility limitations. The investigators hypothesized that sedentary older adults could be recruited for the study, would attend either yoga or a health education control, would complete assessments, and that the interventions could be safely delivered.

Official Title
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Yoga to Prevent Mobility Limitations in Older Adults: A Pilot Randomized Controlled Trial

Conditions
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Aging, Mobility Limitation, Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: Yoga Intervention
* Behavioral: Healthy Aging Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 60-89 years self-reported sedentary lifestyle (not exercising in the past 3 months; included walking at a brisk pace or regular walking for exercise purposes) SPPB summary score > 3 and ≤ 8 willingness attend either yoga or health education for 10 weeks willing to complete two assessments residence in San Diego metropolitan area provided a physician-signed health clearance form. Exclusion Criteria: practiced yoga > 2x in the last year life expectancy < 12 months.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. | Behavioral: Yoga Intervention<br>* The 60-minute yoga sessions began with a brief breathing practice led by the instructor. The yoga instructor then led students through yoga poses at a gentle pace using chairs as props as needed. The pace of the class increased slowly over time as students became more familiar and more capable with the poses. Meditation and breathing was followed by chair poses (15-20 minutes), standing poses (10-15 minutes), floor poses (15 minutes), and lastly a supine resting pose (Savasana; 10 minutes). In the Silver Age Yoga method at that time, there were 73 available postures overall including: 35 Chair Postures, 18 Standing Postures, 20 Floor Postures, with a typical class covering 20-25 poses.<br>|
| Active Comparator: Health Education<br>The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. Sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion. | Behavioral: Healthy Aging Education<br>* The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. The 90-minute sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion. The lecture titles for Weeks 1-10 were as follows: Introduction/ Exploring Communication, The Science of Successful Aging, Acupuncture 101: How it Works & What it is Good for, Quality of Life/Quality of Well Being, Fighting Cancer With Your Fork, Forgiveness via Shakespeare's: A Winter's Tale, Better Eyesight in Minutes a Day, Brain Fitness, The Importance of Organic Foods/ Organic Gardening, How Dementia Can Be Modified. Lectures were provided by a mix of credentialed experts (physicians/psychologists, etc) and other clinicians. Instructors were asked not to talk about yoga or medication in their lectures. Content was not otherwise closely monitored.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery (SPPB) | The Short Physical Performance Battery (SPPB) measures time to walk four meters; time to five chair stands; and balance, with higher scores being associated with decreased disability and mortality. These 3 components are rated on a scale from 0-4 and they are summed to provide a total SPPB score ranging from 0-12. | Change in SPPB from baseline to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step Up and Over (SUO) | The Step Up and Over (SUO) test measures gait quality as it may influence negotiating curbs, climbing or descending stairs, and predicting fall risk. The lift index quantifies the maximum lifting force exerted by the leading leg expressed as a percentage of the individual's weight as measured by the force plate, with scores closer to 100% demonstrating greater force. | Change from baseline to 10 weeks | 
| Rhythmic Weight Shift (RWS) | Rhythmic Weight Shift (RWS) measures participant ability to rhythmically move between two targets at different speeds. The On-Axis Velocity is the speed of the COG displacement in degrees per second during on-axis movement between the test target(s), with greater velocity indicating faster movement through the region of stability | Change from baseline to 10 weeks | 
| Sensory Organization Test (SOT) Vestibular | The SOT assesses the sensory components of balance by measuring postural sway balance in different conditions as a useful predictor of fall risk. The ratio score indicates ability to maintain balance in the presence of inaccurate visual cues. Scores are represented as a percentage from 0 to 100, with scores closer to 100 indicating greater stability. | Change from baseline to 10 weeks | 
| Limits of Stability (LOS) | The LOS is used to define a participant's cone of stability and measures components of balance and stability related to reaction time, directional control, and the ability to make corrective movements. Movement velocity indicates the speed of center of gravity (COG) displacement in degrees per second, with higher values signifying quicker movement through the region of stability. | Change from baseline to 10 weeks | 
| Grip Strength | Grip Strength was assessed with an adjustable, hydraulic grip strength dynamometer.(26) The measure uses the average of two trials for both the left and right hand. | Change from baseline to 10 weeks | 
| SF-36 | The SF-36 has 36 items and takes about 8-10 minutes to complete. The scale measure domains of health-related quality of life and two summary scores corresponding to physical and mental health. Scores for each subscale are standardized and range from 0-100 with higher scores representing better quality of life. | Change from baseline to 10 weeks | 
| Center for Epidemiologic Studies Short Depression Scale (CES-D 10) | Depression was assessed using the 10-item Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Scores can range from 0-30 with higher scores indicating higher levels of depressive symptoms. | Change from baseline to 10 weeks | 
| Brief Anxiety Inventory (BAI) | Anxiety was assessed using the Brief Anxiety Inventory (BAI). The self-administered BAI consists of 21 items, and has well-established reliability(29) and validity. Scores can range from 0-63 with higher scores indicating greater levels of anxiety. | Change from baseline to 10 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) | Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). The measure has 21 items and scores can range from 0-21 with higher scores indicating lower sleep quality. | Change from baseline to 10 weeks | 
| Participant Satisfaction | Participant Satisfaction with participation was rated on a 0-10 scale (10 = most positive) usingquestions about enjoyment with and benefits of participation. | 10 weeks |