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
About this trial
This is an interventional treatment trial for Aging
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.
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
NCT ID
NCT03544879
First Posted
May 18, 2018
Last Updated
October 17, 2019
Sponsor
University of California, San Diego
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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