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Yoga to Prevent Mobility Limitations in Older Adults

Primary Purpose

Aging, Mobility Limitation, Sedentary Lifestyle

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yoga Intervention
Healthy Aging Education
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging

Eligibility Criteria

60 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Yoga

    Health Education

    Arm Description

    The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration..

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 18, 2018
    Last Updated
    October 17, 2019
    Sponsor
    University of California, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03544879
    Brief Title
    Yoga to Prevent Mobility Limitations in Older Adults
    Official Title
    Yoga to Prevent Mobility Limitations in Older Adults: A Pilot Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 6, 2014 (Actual)
    Primary Completion Date
    May 2, 2014 (Actual)
    Study Completion Date
    June 30, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Diego

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aging, Mobility Limitation, Sedentary Lifestyle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Yoga
    Arm Type
    Experimental
    Arm Description
    The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration..
    Arm Title
    Health Education
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Yoga Intervention
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Aging Education
    Intervention Description
    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 Outcome Measure Information:
    Title
    Short Physical Performance Battery (SPPB)
    Description
    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.
    Time Frame
    Change in SPPB from baseline to 10 weeks
    Secondary Outcome Measure Information:
    Title
    Step Up and Over (SUO)
    Description
    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.
    Time Frame
    Change from baseline to 10 weeks
    Title
    Rhythmic Weight Shift (RWS)
    Description
    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
    Time Frame
    Change from baseline to 10 weeks
    Title
    Sensory Organization Test (SOT) Vestibular
    Description
    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.
    Time Frame
    Change from baseline to 10 weeks
    Title
    Limits of Stability (LOS)
    Description
    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.
    Time Frame
    Change from baseline to 10 weeks
    Title
    Grip Strength
    Description
    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.
    Time Frame
    Change from baseline to 10 weeks
    Title
    SF-36
    Description
    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.
    Time Frame
    Change from baseline to 10 weeks
    Title
    Center for Epidemiologic Studies Short Depression Scale (CES-D 10)
    Description
    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.
    Time Frame
    Change from baseline to 10 weeks
    Title
    Brief Anxiety Inventory (BAI)
    Description
    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.
    Time Frame
    Change from baseline to 10 weeks
    Title
    Pittsburgh Sleep Quality Index (PSQI)
    Description
    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.
    Time Frame
    Change from baseline to 10 weeks
    Title
    Participant Satisfaction
    Description
    Participant Satisfaction with participation was rated on a 0-10 scale (10 = most positive) usingquestions about enjoyment with and benefits of participation.
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data is still being analyzed.
    Citations:
    PubMed Identifier
    30541474
    Citation
    Groessl EJ, Maiya M, Schmalzl L, Wing D, Jeste DV. Yoga to prevent mobility limitations in older adults: feasibility of a randomized controlled trial. BMC Geriatr. 2018 Dec 12;18(1):306. doi: 10.1186/s12877-018-0988-8.
    Results Reference
    derived

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    Yoga to Prevent Mobility Limitations in Older Adults

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