Yoga to Prevent Mobility Limitations in Older Adults

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT03544879
• Collaborator: (none)
• Enrollment: 46
• Arms: 2
• Actual Duration (Months): 5.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aging; Mobility Limitation; Sedentary Lifestyle	Behavioral: Yoga Intervention; Behavioral: Healthy Aging Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Yoga to Prevent Mobility Limitations in Older Adults: A Pilot Randomized Controlled Trial
• Actual Study Start Date: Jan 6, 2014
• Actual Primary Completion Date: May 2, 2014
• Actual Study Completion Date: Jun 30, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Yoga 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; 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.
Active Comparator: Health Education 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; 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.

Outcome Measures

Primary Outcome Measures

1. Short Physical Performance Battery (SPPB) [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 Outcome Measures

1. Step Up and Over (SUO) [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) [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 [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) [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 [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 [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) [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) [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) [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 [10 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erik Groessl, Associate Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03544879
• Other Study ID Numbers: 130472
• First Posted: Jun 4, 2018
• Last Update Posted: Oct 21, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mobility Limitation

Study Results

Participant Flow

Arm/Group Title	Yoga	Health Education
Arm/Group Description	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.	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. 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 ex
Period Title: Overall Study
STARTED	22	24
Completed Follow-up Physical Assessment	20	21
COMPLETED	22	23
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Yoga	Health Education	Total
Arm/Group Description	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.	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. 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 ex	Total of all reporting groups
Overall Participants	22	24	46
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	22 100%	24 100%	46 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.6 (8.3)	76.0 (7.8)	73.9 (8.0)
Sex: Female, Male (Count of Participants)
Female	15 68.2%	13 54.2%	28 60.9%
Male	7 31.8%	11 45.8%	18 39.1%
Race/Ethnicity, Customized (Count of Participants)
African-American	0 0%	1 4.2%	1 2.2%
White	18 81.8%	20 83.3%	38 82.6%
Native American	1 4.5%	0 0%	1 2.2%
Asian/Pacific Islander	0 0%	1 4.2%	1 2.2%
Hispanic	3 13.6%	2 8.3%	5 10.9%
Region of Enrollment (participants) [Number]
United States	22 100%	24 100%	46 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga	Health Education
Arm/Group Description	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.	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. 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 ex
Measure Participants	20	21
Mean (Standard Deviation) [units on a scale]	1.55 (1.67)	1.18 (1.33)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

2 participants in each group completed written self-report measures but not physical assessments at 10 weeks (follow-up).

Arm/Group Title	Health Education	Yoga
Arm/Group 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.	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.
Measure Participants	21	20
Mean (Standard Deviation) [percent of weight]	-0.65 (9.0)	8.7 (26.3)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

2 participants in each group completed written self-report measures but not physical assessments at 10 weeks (follow-up).

Arm/Group Title	Health Education	Yoga
Arm/Group 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.	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.
Measure Participants	21	20
Mean (Standard Deviation) [degrees per second]	0.07 (1.14)	-0.15 (0.83)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

2 participants in each group completed written self-report measures but not physical assessments at 10 weeks (follow-up).

Arm/Group Title	Health Education	Yoga
Arm/Group 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.	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.
Measure Participants	21	20
Mean (Standard Deviation) [percent stability maintained]	-1.1 (23.8)	8.9 (29.1)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

2 participants in each group completed written self-report measures but not physical assessments at 10 weeks (follow-up).

Arm/Group Title	Health Education	Yoga
Arm/Group 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.	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.
Measure Participants	21	20
Mean (Standard Deviation) [degrees per second]	-0.62 (1.62)	0.51 (1.61)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

2 participants in each group completed written self-report measures but not physical assessments at 10 weeks (follow-up).

Arm/Group Title	Yoga	Health Education
Arm/Group Description	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.	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. 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 ex
Measure Participants	20	21
Mean (Standard Deviation) [pounds of pressure]	0.12 (8.03)	-5.2 (11.72)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga	Health Education
Arm/Group Description	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.	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. 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 ex
Measure Participants	22	23
Physical	0.23 (5.99)	-1.2 (5.21)
Mental	0.7 (5.6)	-3.2 (7.7)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga	Health Education
Arm/Group Description	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.	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. 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 ex
Measure Participants	22	23
Mean (Standard Deviation) [units on a scale]	-0.35 (3.15)	1.14 (3.59)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga	Health Education
Arm/Group Description	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.	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. 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 ex
Measure Participants	22	23
Mean (Standard Deviation) [units on a scale]	0.18 (7.48)	2.87 (5.89)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga	Health Education
Arm/Group Description	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.	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. 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 ex
Measure Participants	22	23
Mean (Standard Deviation) [units on a scale]	-0.5 (2.52)	-0.2 (2.27)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Health Education	Yoga
Arm/Group 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.	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.
Measure Participants	23	22
Mean (Standard Deviation) [units on a scale]	8.1 (2.7)	8.4 (2.8)

Adverse Events

Time Frame	10 weeks
Arm/Group Title	Yoga		Health Education
Arm/Group Description	The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration.. Yoga Intervention: 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.		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. 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 ex
All Cause Mortality
	Yoga		Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/24 (0%)
Serious Adverse Events
	Yoga		Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Yoga		Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/22 (59.1%)		9/24 (37.5%)
Musculoskeletal and connective tissue disorders
Increased pain	13/22 (59.1%)	13	9/24 (37.5%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.