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

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ClinicalTrials.gov Identifier: NCT02443038
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Patient Fall Other: Yoga Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Yoga's Effect on Fall Risk Factors in the Rural, Older Adult Population; an Academic/Community Partnership
Study Start Date : April 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Active Comparator: Home Exercise
Participants will practice 10 minutes of yoga in addition to 5 minutes of relaxation exercises at home each day when not in class.
Other: Yoga

16 bi-weekly 50-60 minute yoga classes, followed by daily, 10 minute home exercise poses and 5 minute relaxation, the control group will practice 5 minutes relaxation, each day between classes.

The first of 3 classes is the 8-10 member advisory board, the second and third classes with 10-15 participants in each workshop will be held in other counties. 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.


Placebo Comparator: Relaxation Exercise
Participants will practice 5 minutes of relaxation exercises at home each day when not in class.
Other: Yoga

16 bi-weekly 50-60 minute yoga classes, followed by daily, 10 minute home exercise poses and 5 minute relaxation, the control group will practice 5 minutes relaxation, each day between classes.

The first of 3 classes is the 8-10 member advisory board, the second and third classes with 10-15 participants in each workshop will be held in other counties. 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.





Primary Outcome Measures :
  1. occurence of falls [ Time Frame: 6 months ]
    incidence and number of falls that occur for participants during the study


Secondary Outcome Measures :
  1. Improved Balance [ Time Frame: 6 months ]
    validated balance testing including the Berg Balance Scale, and testing of walking performance using the Functional Gait Assessment at the beginning and end of program.

  2. qualitative information about feasibility of yoga in rural older adults [ Time Frame: 6 months ]
    survey and discussion with participants and advisory board members

  3. time to first fall [ Time Frame: 6 months ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443038


Locations
United States, Wisconsin
Aging and Disability Resource Center- Iowa and Lafayette Counties
Dodgeville, Wisconsin, United States, 53533
Aging and Disability Resource Center-Green County
Monroe, Wisconsin, United States, 53566
Aging and Disability Resource Center-Grant County
Platteville, Wisconsin, United States, 53818
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Irene Hamrick, MD University of Wisconsin, Madison

Publications:
CDC. (2009). http://www.cdc.gov/injury/wisqars/fatal_injury_reports.html

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02443038     History of Changes
Other Study ID Numbers: WPP2774
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share our data after analysis and peer review of publication

Keywords provided by University of Wisconsin, Madison:
patient fall
yoga
balance