Clinical trial NCT02443038: Yoga's Effect on Fall Risk Factors in the Rural, Older Adult Population; an Academic/Community Partnership
Official title: Yoga's Effect on Fall Risk Factors in the Rural, Older Adult Population; an Academic/Community Partnership
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Fall
Keywords: patient fall
yoga
balance
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 43
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a 2 year pilot/feasibility project to develop an intervention, test research methods, and evaluate the effects of yoga on core strength and balance of an older rural population in an effort to ultimately reduce the frequency of falls. The investigators' goal for this project is for community and academic partners to develop a yoga program that is feasible, safe, and acceptable to an older adult population, then test the program, research methods and evaluation, in preparation for conducting a larger randomized trial of the intervention.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: occurence of falls
timeFrame: 6 months
Secondary outcomes:
measure: Improved Balance
timeFrame: 6 months
measure: qualitative information about feasibility of yoga in rural older adults
timeFrame: 6 months
measure: time to first fall
timeFrame: 6 months
Other outcomes:
Locations:
city: Dodgeville
country: United States
facility: Aging and Disability Resource Center- Iowa and Lafayette Counties
state: Wisconsin
city: Monroe
country: United States
facility: Aging and Disability Resource Center-Green County
state: Wisconsin
city: Platteville
country: United States
facility: Aging and Disability Resource Center-Grant County
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Irene Hamrick, MD
role: PRINCIPAL_INVESTIGATOR
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