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Completed

NCT Number: NCT03544879

Yoga to Prevent Mobility Limitations in Older Adults

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.

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Key information

Conditions

Aging Behavior Mobility Limitation Pathological Conditions, Signs and Symptoms Sedentary Behavior Sedentary Lifestyle Signs and Symptoms

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yoga intervention

Behavioral

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.

Healthy Aging Education

Behavioral

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.

Primary outcomes

  1. Short Physical Performance Battery (SPPB)

    Time frame: Change in SPPB from baseline to 10 weeks

    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.

Secondary outcomes

  1. Step Up and Over (SUO)

    Time frame: Change from baseline to 10 weeks

    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.

  2. Rhythmic Weight Shift (RWS)

    Time frame: Change from baseline to 10 weeks

    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

  3. Sensory Organization Test (SOT) Vestibular

    Time frame: Change from baseline to 10 weeks

    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.

  4. Limits of Stability (LOS)

    Time frame: Change from baseline to 10 weeks

    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.

  5. Grip Strength

    Time frame: Change from baseline to 10 weeks

    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.

  6. SF-36

    Time frame: Change from baseline to 10 weeks

    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.

  7. Center for Epidemiologic Studies Short Depression Scale (CES-D 10)

    Time frame: Change from baseline to 10 weeks

    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.

  8. Brief Anxiety Inventory (BAI)

    Time frame: Change from baseline to 10 weeks

    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.

  9. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline to 10 weeks

    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.

  10. Participant Satisfaction

    Time frame: 10 weeks

    Participant Satisfaction with participation was rated on a 0-10 scale (10 = most positive) usingquestions about enjoyment with and benefits of participation.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2018
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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