Yoga's Effect on Fall Risk Factors in the Rural, Older Adult Population; an Academic/Community Partnership

This is a 2 year pilot project to develop an intervention, and to test research methods and
evaluation to assess the effects of yoga on core strength and balance of an older population
in an effort to ultimately reduce the frequency of falls. The literature suggests that
increased core body strength improves balance and reduces fall frequency in the elderly.
Yoga increases core strength. There is limited evidence that regular yoga exercising is
associated with a decreased frequency of falls in the older adult population. However, there
have not been any randomized trials testing the impact of a yoga program on fall frequency.
The investigators' goal for this project is to develop a yoga program that is feasible,
safe, and acceptable to an older population then test the intervention, research methods and
evaluation in preparation for conducting a randomized trial of the intervention.

This study is conducted with the investigators community partner, the aging and disabilities
resource center (ADRC) of Southwest Wisconsin. The ADRC will help with recruiting, posting
on ADRC's website and flyers. The ADRC will provide locations for classes and assessments.
Recruitment will also occur through local community event announcements.

An advisory board of 8-10 members of older adults will inform about needs and feasibility,
and help review the handbook and video. The advisory boards involvement will be in the
preparatory phase of the research, along with full project oversight.

Enrollment Questionnaire

Eligible subjects will be asked to complete a brief questionnaire. The questionnaire will
include questions about: 1) Demographics including age, gender, race, ethnicity, years of
education, income level, 2) Number of falls in the past 1 month, 6 months and 1 year, and 3)
Fear of falling questions using the ABC (Activities-specific Balance Confidence Scale).

Visit 2- Physical Activity Assessment

The physical activity assessment will be conducted one-on-one by a Physical Therapist and
occur at the individual ADRC offices where yoga classes will be held. Height and weight will
be measured during the first assessment only. Testing will consist of 3 low physical demand
tests of static and dynamic balance and gait characteristics: 1) The Berg Balance Scale, 2)
The Functional Gait Assessment, and 3) The Dynamic Gait Index. Each of these tests requires
a minimal to moderate amount of exertion, typically not enough to cause any shortness of
breath with transient mild increase in heart rate. The total time anticipated to conduct the
testing is 60 minutes.

The investigators chose these tests because they are validated measures for the
investigators' subject population, do not require any special equipment, take only a few
minutes to administer, and are safe to perform in an older adult population.

Visits 3 to 18- Intervention

The intervention consists of 16 bi-weekly 50-60 minute yoga classes, conducted by certified
yoga therapists, and in case of the advisory group, after classes questions about
improvement of classes that will take about 5 minutes. Additionally, 10 minute home exercise
poses and 5 minute relaxation will be done each day between classes. The control group will
practice 5 minutes relaxation on days between classes.

There will be 3 classes (in 3 different counties), the first is the 8-10 member advisory
board. The second and third classes will have 10-15 participants in each workshop. The
target is up to 60 total participants (including advisory board). There will be 2-3 months
between the first set of classes and second and third set of classes to refine methods and
conduct enrollment and testing for the subsequent groups.

A co-investigator will give out envelopes that contain the patient assignment to home
practice or no home practice during the 3rd visit. The envelopes will be numbered and
participants will randomly choose among the envelopes. The co-investigator will note the
participant name and the envelope number but will not know the content of the envelope with
the assignment. Another investigator will have noted the assignment to home exercise or
control and the envelope number in a file that will be saved on a password protected
computer in the investigators office and backed up on a UW- Madison secured server. A
printout will be placed in a sealed envelope and kept in a locked ADRC office to be opened
upon completion of data collection.

The general philosophy of the yoga classes is to create an environment of safety during all
poses and avoid a culture of competition or subjects pushing themselves beyond individual
abilities. Classes will consist of: 1) Centering; 2) Warm up; 3) A variety of simple poses
with modifications to increase safety and reduce potential for falls (pictures of examples
included in the manual as described/illustrated below, including 3 home practice poses; 4)
cool down; and 5) 5 minute relaxation period. Poses will focus on alignment principles,
lower extremity and core strengthening, and common flexibility deficits thought to be
related to impaired balance. Modifications for individual range of motion will be provided
as necessary. Poses will be supplemented or advanced to accommodate individual needs.

Subjects (intervention group) will also be asked to perform a set of poses at home taking
approximately 10 minutes each day. The poses will be illustrated with photos in the home
log. The home exercises will be performed daily each week on days other than class days.
Subjects will record home activity as below.

Home Log Book and Data Collection, during the Intervention

Subjects (intervention group) will be given a home log book at the first yoga class. The log
book includes general instructions, researcher contact information and specific instructions
for the 3 home poses including picture illustrations. Subjects will be instructed to record
the date and length of time each time the subjects do home poses and any discomfort or
problems that occur with home exercises. Poses will be supplemented or advanced to
accommodate individual needs. Subjects will be instructed to bring the log books to each
class so instructors can check to see if the log books are being completed correctly and
assess for any adverse events (AEs) and unanticipated problems (UPs).

Subjects will also track falls during the 8 week intervention and the 4 months following the
completion of the intervention.

Home Log study control group

Half of the class will be randomized into either a home exercise group or a control group
which will not do any yoga exercises outside of the classroom environment. The control group
will be encouraged to do the yoga poses learned in class at home after the class is
complete.

Instructors will record subject attendance at each class, if the subjects brought log book
and AEs or UPS. Instructors will also record total class time from start to finish and all
the poses done during the class into a spreadsheet.

The investigators anticipate that total twice weekly yoga classes will take 16 hours and the
home activities will take about (5 x 15 minutes x 16 weeks) 20 total hours for the group
assigned to home exercises and (5 x 5 minutes x 16 weeks) about 6.5 hours for the control
group. Total time involvement including 16 hours of class time, enrollment visit and pre and
post assessment visits is about 40 hours for the intervention group and 26 hours for the
control group.

Visit 19- Repeat Physical Assessment and Questionnaire

Final assessment will occur within 2 weeks of the final yoga class. Instructors and
investigators will strongly encourage all participants, including drop outs, to complete the
final assessment. Final assessment will include: 1) A questionnaire with the
pre-intervention falls related survey questions (including the ABC (Activities-specific
Balance Confidence Scale), additional questions about the yoga classes, home exercises and
use of the logbook; 2) Post-intervention physical activity assessment. The post-intervention
physical assessment is the same as the initial assessment except the height and weight are
not re-measured. This final visit is expected to last about 1 hour.

A co-investigator will call participants 2 months and 4 months after completing the class,
to ask questions about falls and yoga practice at home. Each phone call will take about 5
minutes.

Sample Size and Analysis:

Since this is a pilot program to develop the intervention and assessment methods, the
investigators sample size of up to 60 subjects is based on practicality and limited by
available time and funding. Based on previous yoga teaching experience, 14 people is a
manageable class size to allow for personal attention to adjust poses as necessary for
subject safety for each of the groups. The investigators anticipate 20% drop out rate with a
final sample size of up to 48 subjects. With this small sample size, and moderate level of
pre-intervention physical function of the subjects, the investigators may not find
significant changes in the physical activity measures. The investigators do hope to find
some trend toward increased ability to maintain balance. Descriptive statistics will be used
to create summed scores for fall questions. Paired tests and repeated-measures analysis of
variance (ANOVA) will be used to analyze the pre- intervention and post- intervention
physical activity measures.

Inclusion Criteria:

1. Males and females

2. Age 60 and older

3. Able to walk 150 feet without assistive devices such as a cane or walker. This is a
commonly used definition of an "independent ambulator" according to the Functional
Independence Measure.

4. Cognitively intact as evidenced by correct answers to the mini-cogMemory Impairment
Screen.

5. Able to provide informed consent.

Exclusion Criteria:

1. Pelvic or lower extremity injury in the previous 6 months that required temporary use
of an assistive device, including crutches, for more than 7 days.

2. Pelvic or lower extremity orthopedic surgery in the previous 12 months.

3. Cardiac or other medical condition with previous physician instructions to avoid low
intensity exercise.

4. Neurologic condition that impairs strength or balance including herniated lumbar disc
with nerve root compression, previous stroke with residual lower extremity weakness,
Parkinson's Disease, Multiple Sclerosis, muscular dystrophy and other neuromuscular
diseases.

5. Terminal condition with rapid progression of disease and not expected to live 6
months or more.

6. Inability to provide informed consent

7. Practiced yoga at home or in a classroom setting in the past 6 months.