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

NCT02443038 | Completed

• 1 other identifier: WPP2774
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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.

Conditions

Patient Fall

Keywords

patient fall; yoga; balance

Outcome Measures

Primary Outcomes (1)

• occurence of falls

  incidence and number of falls that occur for participants during the study

  6 months

Secondary Outcomes (3)

• Improved Balance

  6 months

• qualitative information about feasibility of yoga in rural older adults

  6 months

• time to first fall

  6 months

Study Arms (2)

Home Exercise

ACTIVE COMPARATOR

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

Relaxation Exercise

PLACEBO COMPARATOR

Participants will practice 5 minutes of relaxation exercises at home each day when not in class.

Other: Yoga

Interventions

Yoga OTHER

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.

Home Exercise; Relaxation Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• Age 60 and older
• 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.
• Cognitively intact as evidenced by correct answers to the mini-cogMemory Impairment Screen.
• Able to provide informed consent.

You may not qualify if:

• 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.
• Pelvic or lower extremity orthopedic surgery in the previous 12 months.
• Cardiac or other medical condition with previous physician instructions to avoid low intensity exercise.
• 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.
• Terminal condition with rapid progression of disease and not expected to live 6 months or more.
• Inability to provide informed consent
• Practiced yoga at home or in a classroom setting in the past 6 months.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (3)

Aging and Disability Resource Center- Iowa and Lafayette Counties

Dodgeville, Wisconsin, 53533, United States

Location

Aging and Disability Resource Center-Green County

Monroe, Wisconsin, 53566, United States

Location

Aging and Disability Resource Center-Grant County

Platteville, Wisconsin, 53818, United States

Location

Related Publications (20)

• Berg K, Wood-Dauphinee S, Williams JI. The Balance Scale: reliability assessment with elderly residents and patients with an acute stroke. Scand J Rehabil Med. 1995 Mar;27(1):27-36.

  PMID: 7792547 BACKGROUND

• Brown KD, Koziol JA, Lotz M. A yoga-based exercise program to reduce the risk of falls in seniors: a pilot and feasibility study. J Altern Complement Med. 2008 Jun;14(5):454-7. doi: 10.1089/acm.2007.0797. No abstract available.

  PMID: 18564950 BACKGROUND

• Chiu YP, Fritz SL, Light KE, Velozo CA. Use of item response analysis to investigate measurement properties and clinical validity of data for the dynamic gait index. Phys Ther. 2006 Jun;86(6):778-87.

  PMID: 16737403 BACKGROUND

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

  BACKGROUND

• DiBenedetto M, Innes KE, Taylor AG, Rodeheaver PF, Boxer JA, Wright HJ, Kerrigan DC. Effect of a gentle Iyengar yoga program on gait in the elderly: an exploratory study. Arch Phys Med Rehabil. 2005 Sep;86(9):1830-7. doi: 10.1016/j.apmr.2005.03.011.

  PMID: 16181950 BACKGROUND

• Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.

  PMID: 22972103 BACKGROUND

• Hausdorff JM, Rios DA, Edelberg HK. Gait variability and fall risk in community-living older adults: a 1-year prospective study. Arch Phys Med Rehabil. 2001 Aug;82(8):1050-6. doi: 10.1053/apmr.2001.24893.

  PMID: 11494184 BACKGROUND

• Hornbrook MC, Stevens VJ, Wingfield DJ, Hollis JF, Greenlick MR, Ory MG. Preventing falls among community-dwelling older persons: results from a randomized trial. Gerontologist. 1994 Feb;34(1):16-23. doi: 10.1093/geront/34.1.16.

  PMID: 8150304 BACKGROUND

• Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18. No abstract available.

  PMID: 3503663 BACKGROUND

• Kerrigan DC, Lee LW, Collins JJ, Riley PO, Lipsitz LA. Reduced hip extension during walking: healthy elderly and fallers versus young adults. Arch Phys Med Rehabil. 2001 Jan;82(1):26-30. doi: 10.1053/apmr.2001.18584.

  PMID: 11239282 BACKGROUND

• Kerrigan DC, Todd MK, Della Croce U, Lipsitz LA, Collins JJ. Biomechanical gait alterations independent of speed in the healthy elderly: evidence for specific limiting impairments. Arch Phys Med Rehabil. 1998 Mar;79(3):317-22. doi: 10.1016/s0003-9993(98)90013-2.

  PMID: 9523785 BACKGROUND

• Krishnamurthy M, Telles S. Effects of Yoga and an Ayurveda preparation on gait, balance and mobility in older persons. Med Sci Monit. 2007 Dec;13(12):LE19-20. No abstract available.

  PMID: 18049442 BACKGROUND

• Lipton RB, Katz MJ, Kuslansky G, Sliwinski MJ, Stewart WF, Verghese J, Crystal HA, Buschke H. Screening for dementia by telephone using the memory impairment screen. J Am Geriatr Soc. 2003 Oct;51(10):1382-90. doi: 10.1046/j.1532-5415.2003.51455.x.

  PMID: 14511157 BACKGROUND

• Oken BS, Zajdel D, Kishiyama S, Flegal K, Dehen C, Haas M, Kraemer DF, Lawrence J, Leyva J. Randomized, controlled, six-month trial of yoga in healthy seniors: effects on cognition and quality of life. Altern Ther Health Med. 2006 Jan-Feb;12(1):40-7.

  PMID: 16454146 BACKGROUND

• Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.

  PMID: 7814786 BACKGROUND

• Ross A, Thomas S. The health benefits of yoga and exercise: a review of comparison studies. J Altern Complement Med. 2010 Jan;16(1):3-12. doi: 10.1089/acm.2009.0044.

  PMID: 20105062 BACKGROUND

• VanSwearingen JM, Paschal KA, Bonino P, Yang JF. The modified Gait Abnormality Rating Scale for recognizing the risk of recurrent falls in community-dwelling elderly adults. Phys Ther. 1996 Sep;76(9):994-1002. doi: 10.1093/ptj/76.9.994.

  PMID: 8790277 BACKGROUND

• Wolfson L, Whipple R, Amerman P, Tobin JN. Gait assessment in the elderly: a gait abnormality rating scale and its relation to falls. J Gerontol. 1990 Jan;45(1):M12-9. doi: 10.1093/geronj/45.1.m12.

  PMID: 2295773 BACKGROUND

• Wrisley DM, Kumar NA. Functional gait assessment: concurrent, discriminative, and predictive validity in community-dwelling older adults. Phys Ther. 2010 May;90(5):761-73. doi: 10.2522/ptj.20090069. Epub 2010 Apr 1.

  PMID: 20360052 BACKGROUND

• Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.

  PMID: 15449976 BACKGROUND

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Irene Hamrick, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: May 13, 2015
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (3)