- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03544879
Yoga to Prevent Mobility Limitations in Older Adults
October 17, 2019 updated by: Erik Groessl, University of California, San Diego
Yoga to Prevent Mobility Limitations in Older Adults: A Pilot Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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..
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change in SPPB from baseline to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline to 10 weeks
|
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
|
Change from baseline to 10 weeks
|
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.
|
Change from baseline to 10 weeks
|
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.
|
Change from baseline to 10 weeks
|
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.
|
Change from baseline to 10 weeks
|
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.
|
Change from baseline to 10 weeks
|
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.
|
Change from baseline to 10 weeks
|
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.
|
Change from baseline to 10 weeks
|
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.
|
Change from baseline to 10 weeks
|
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.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2014
Primary Completion (Actual)
May 2, 2014
Study Completion (Actual)
June 30, 2014
Study Registration Dates
First Submitted
May 18, 2018
First Submitted That Met QC Criteria
May 31, 2018
First Posted (Actual)
June 4, 2018
Study Record Updates
Last Update Posted (Actual)
October 21, 2019
Last Update Submitted That Met QC Criteria
October 17, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 130472
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data is still being analyzed.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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