- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01411059
Yoga Empowers Seniors Study (YESS)
November 14, 2016 updated by: George Salem, University of Southern California
Safe and Effective Yoga Prescription of Seniors: Biomechanical Considerations
This is an Intervention Development Study (IDS) to quantify the physical demands (using biomechanical investigation) of a 2-phase (beginning & intermediate), 32-week yoga program designed for community-dwelling older adults.
Additionally, the IDS will explore the adherence and adverse events of participation in the program.
Data from the IDS will be used to develop evidenced-based yoga programs, which the investigators postulate will be associated with fewer musculoskeletal side effects compared to non-evidence based yoga programs.
The investigators also postulate that evidenced-based tailoring of yoga for seniors will enhance adherence and efficacy.
The programs developed during this IDS will be tested in an expanded, Phase II, Randomized Controlled Trial.
Study Overview
Detailed Description
Yoga is currently being recommended to restore and preserve strength, flexibility, balance, & physical capacity in older adults; however, our clinical trial experiences suggest that without proper evidenced-based prescription, Yoga participation can be ineffective or even injurious for seniors.
To address this lack of evidence-based knowledge, the proposed IDS will: 1) quantify the physical demands of a 32-wk Yoga program designed for independent ambulatory seniors; 2) characterize the relations between these demands and participant physical characteristics; 3) examine the adherence, efficacy, & safety of the program; and 4) characterize the relations among reported adverse events, baseline participant characteristics, and Yoga physical demands.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90024
- UCLA
-
-
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Community dwelling men and women volunteers, aged 65 years or older.
Exclusion Criteria:
Safety exclusions:
--the following safety exclusions are adopted in order to decrease potential *cardiovascular
- musculoskeletal
- neurological risks to the participants:
- active angina
- uncontrolled hypertension (SBP greater than 160 or DBP greater than 90)
- high resting pulse or respiratory rate (HR >90 or RR>24 after 5 minutes seated)
- unstable asthma or exacerbated COPD
- cervical spine instability or other significant neck injury
- rheumatoid arthritis
- unstable ankle, knee, hip, shoulder, elbow, or wrist joints
- hemiparesis or paraparesis
- movement disorders (e.g. Parkinson's disease), peripheral neuropathies, stroke with residual deficits, severe vision or hearing problems
- walker or wheelchair use
- insufficient hearing to permit safety in a yoga group setting
- not able to attend in-person classes
- has not had check-up by regular provider within 12 months (if not taking any prescription medications) or in the past 6 months (if any regular medicines taken); cannot pass specific movement safety tests (tests described in section on screening visits, below)
Feasibility/adherence exclusions:
- unable to understand their commitment to the project, (laboratory visits & regular program participation)
- cognitive limitations significant enough to preclude informed consent or to raise concerns about participation safety
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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: yoga
32 weeks of yoga training
|
yoga classes 2 times per week for 32 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
peak joint moments
Time Frame: difference from baseline to 16 wk
|
These are the torques produced by the muscles during performance of the yoga poses
|
difference from baseline to 16 wk
|
|
peak joint moments
Time Frame: difference from 16 wk to 32 wk
|
These are the torques produced by the muscles during performance of the yoga poses
|
difference from 16 wk to 32 wk
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time to stand and sit from a chair 5 times
Time Frame: baseline, 16 and 32 weeks
|
In the 5-Repetition Chair Stand Test, we record the time it takes for a participant to repeatedly stand and sit on a chair 5 times.
|
baseline, 16 and 32 weeks
|
|
number of heel-rise repetitions
Time Frame: baseline, 16 and 32 weeks
|
The Heel-Rise Test is a measure of plantar-flexion endurance.
Here, we record the number of full range-of-motion, heel-rise repetitions the participants can complete before fatigue.
|
baseline, 16 and 32 weeks
|
|
Time to complete Up & Go test
Time Frame: baseline, 16 and 32 weeks
|
In the Up & Go Test, a measure of mobility, we record the number of seconds it takes to rise from a chair, walk 8 feet, return and sit in the chair.
|
baseline, 16 and 32 weeks
|
|
Number of marching steps completed within 2 minutes
Time Frame: baseline, 16 and 32 weeks
|
In the 2-Minute Step Test, a measure stepping endurance, we record the number of complete marching steps the participant can perform within a 2-minute period
|
baseline, 16 and 32 weeks
|
|
Distance participant can reach forward from a sitting position
Time Frame: baseline, 16 and 32 weeks
|
The sit and reach test measures overall sagittal-plane flexibility.
The participant is asked to reach as far as possible toward their dominant limb while remaining seated.
|
baseline, 16 and 32 weeks
|
|
Distance between fingers of opposing hands as participant attempts to touch fingers while reaching posteriorly.
Time Frame: baseline, 16 and 32 weeks
|
The Back Scratch Test measures upper extremity flexibility.
Here the distance between finger-tips is recorded as the participant reaches posteriorly and attempts to touch opposing hands.
|
baseline, 16 and 32 weeks
|
|
Maximum passive wrist flexion, extension, radial-deviation, and ulnar-deviation, range of motion (in degrees).
Time Frame: baseline, 16 and 32 weeks
|
These tests measure the range of motion of the wrist in the sagittal and frontal planes.
|
baseline, 16 and 32 weeks
|
|
Maximum height participant can reach while standing
Time Frame: baseline, 16 and 32 weeks
|
Here we quantify the maximum vertical height participants can reach while standing.
|
baseline, 16 and 32 weeks
|
|
Maximum distance participant can reach forward while standing
Time Frame: baseline, 16 and 32 weeks
|
THe Maximum Forward Reach test is a measure of strength and flexibility.
Here we record the maximum distance the participant can reach forward while standing.
|
baseline, 16 and 32 weeks
|
|
stride length during walking
Time Frame: baseline, 16 and 32 weeks
|
Here we quantify the stride length of participants during walking at a self-selected pace.
|
baseline, 16 and 32 weeks
|
|
Maximum joint angle
Time Frame: baseline, 16 and 32 weeks
|
Here we quantify the maximum joint angles of the ankle, knee, hip, trunk, shoulder, elbow, and wrist during performance of the yoga poses.
|
baseline, 16 and 32 weeks
|
|
Sway distance of the center of pressure
Time Frame: baseline, 16 and 32 weeks
|
Here we quantify the movement of the center of pressure as participants stand as still as possible
|
baseline, 16 and 32 weeks
|
|
Electromyographic activity of muscles
Time Frame: baseline, 16 and 32 weeks
|
Here we record the electromyographic activity of the Anterior Deltoid, Triceps surae, Obliques, Rectus Abdominus, Erector Spinae, Gluteus Maximus, Lateral Hamstrings, Vastus Lateralis, Gastrocnemius, and Gluteus Medius, muscles during performance of the yoga poses.
|
baseline, 16 and 32 weeks
|
|
SF-36 score
Time Frame: baseline and 36 weeks
|
Health related quality of life and mood will be assessed with the RAND Short Form-36 (Hays, 1993).
The SF-36 includes sub-scales that measure: 1) health-related limitations in physical function; 2) health-related limitations in role and in social function; 3) emotional function (including positive and negative mood states); 4) pain.
|
baseline and 36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: George Salem, PhD, University of Southern California
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
July 1, 2009
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
July 20, 2011
First Submitted That Met QC Criteria
August 4, 2011
First Posted (Estimate)
August 5, 2011
Study Record Updates
Last Update Posted (Estimate)
November 16, 2016
Last Update Submitted That Met QC Criteria
November 14, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R01AT004869-01 (U.S. NIH Grant/Contract)
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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