Home Based Exercise in Preventing Fall and Improving Balance in Older People

• ClinicalTrials.gov Identifier: NCT02089815
• Recruitment Status: Completed
• First Posted: March 18, 2014
• Last Update Posted: April 13, 2015
• Sponsor: Mahidol University
• Information provided by (Responsible Party): Chitima Boongird, Mahidol University

Tracking Information

• First Submitted Date: March 10, 2014
• First Posted Date: March 18, 2014
• Last Update Posted Date: April 13, 2015
• Study Start Date: August 2013
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 17, 2014)

number of falls [ Time Frame: 1 year ]

Number of falls were measured at baseline, 12 weeks, 24 weeks and 1 year. At baseline, the participants will be interviewed the number of falls that occurred in the past 1 year period before enrollment.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 17, 2014)

• muscle strength [ Time Frame: baseline, 12 weeks and 24 weeks ]
  There are two Measurements as following:

  1. Five time sit to stand test The participant stood up and sat down as quickly as possible from standard chair (47 cm high) 5 times, with arms folded across the chest.
  2. Timed up and go test The time required to rise from a chair, walk 3 meters distance, turn around, walk back and sit down.
• Balance [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  The participants will be tested their balances by using Short form of Berg Balance scale (7 items, 0-28 scores.)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 17, 2014)

• fear of falling [ Time Frame: baseline and at 24 weeks. ]
  Thai Falls efficacy scale-international (FES-I)
• Quality of life [ Time Frame: 1 year ]
  The participants will be interviewed by using Thai EQ-5D questionaires.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Home Based Exercise in Preventing Fall and Improving Balance in Older People
• Official Title: Effectiveness of a Simple Designed Programme of Home Based Exercise in Preventing Fall and Improving Balance and Strength in Older People With Mild to Moderate Balance Dysfunction: A Randomized Controlled Trials
• Brief Summary: Prior studies have shown multifaceted falls prevention program with home-based exercise reduced falls significantly in the community setting. The Otago exercise program has been tested in four separated controlled trials of community living people in New Zealand. Falls were the main outcome in each trail and were defined as "unintentionally coming to rest on the ground, floor or other lower level". Not only this combination strengthening and balance training exercise could reduce fall but also could benefit in cost-effectiveness for fall prevention and decrease mortality in those 80 and older. However the limitation of Otago exercise program is that the program was needed to be trained by skill nurses or physical therapists. There are 17 steps levels to adhere the program. As some studies have shown that fall prevention program adherence could be as low as 10-40%. In Thailand the lack of medical staffs are continued the problem in the community. Therefore to establish fall prevention guideline that will be suitable and translated into the real setting, this study is aimed to test the effectiveness of simple program home-based exercise comparing to non-simple program home based exercise in preventing fall and improve muscle strength and balance dysfunction in older people with mild to moderate balance dysfunction. The method is the randomized controlled trails.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Patient Fall
• Muscle Balance
• Fear of Falling
• Quality of Life

Intervention

• Behavioral: Home based exercise
  modified Otago exercise program to simple designed home based exercise program
  Other Name: combination strengthening and balance training program
• Other: fall prevention education and counseling

Study Arms

• Experimental: Home based exercise
  simple designed home based exercise program
  Interventions:

  • Behavioral: Home based exercise
  • Other: fall prevention education and counseling
• Active Comparator: fall prevention education and counseling
  fall prevention education & counseling : home modification, vision screening, avoid sedative drugs use, proper shoes, report dizziness and fall to doctors
  Intervention: Other: fall prevention education and counseling

Publications *

• Day L. The Otago strength and balance exercise programme lowers the risk of death and falls in the older people at 12 months. Evid Based Nurs. 2011 Jul;14(3):76-8. doi: 10.1136/ebn1157. Epub 2011 Mar 24.
• Kuptniratsaikul V, Praditsuwan R, Assantachai P, Ploypetch T, Udompunturak S, Pooliam J. Effectiveness of simple balancing training program in elderly patients with history of frequent falls. Clin Interv Aging. 2011;6:111-7. doi: 10.2147/CIA.S17851. Epub 2011 May 6.
• Yang XJ, Hill K, Moore K, Williams S, Dowson L, Borschmann K, Simpson JA, Dharmage SC. Effectiveness of a targeted exercise intervention in reversing older people's mild balance dysfunction: a randomized controlled trial. Phys Ther. 2012 Jan;92(1):24-37. doi: 10.2522/ptj.20100289. Epub 2011 Oct 6.
• Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997 Oct 25;315(7115):1065-9.
• Sherrington C, Whitney JC, Lord SR, Herbert RD, Cumming RG, Close JC. Effective exercise for the prevention of falls: a systematic review and meta-analysis. J Am Geriatr Soc. 2008 Dec;56(12):2234-43. doi: 10.1111/j.1532-5415.2008.02014.x. Review.
• Simek EM, McPhate L, Haines TP. Adherence to and efficacy of home exercise programs to prevent falls: a systematic review and meta-analysis of the impact of exercise program characteristics. Prev Med. 2012 Oct;55(4):262-275. doi: 10.1016/j.ypmed.2012.07.007. Epub 2012 Jul 17. Review.
• Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD004963. doi: 10.1002/14651858.CD004963.pub3. Review.
• Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4. Review.
• Gates S, Fisher JD, Cooke MW, Carter YH, Lamb SE. Multifactorial assessment and targeted intervention for preventing falls and injuries among older people in community and emergency care settings: systematic review and meta-analysis. BMJ. 2008 Jan 19;336(7636):130-3. Epub 2007 Dec 18. Review.
• Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007146. doi: 10.1002/14651858.CD007146.pub2. Review. Update in: Cochrane Database Syst Rev. 2012;9:CD007146.
• Day L, Fildes B, Gordon I, Fitzharris M, Flamer H, Lord S. Randomised factorial trial of falls prevention among older people living in their own homes. BMJ. 2002 Jul 20;325(7356):128.
• Fabacher D, Josephson K, Pietruszka F, Linderborn K, Morley JE, Rubenstein LZ. An in-home preventive assessment program for independent older adults: a randomized controlled trial. J Am Geriatr Soc. 1994 Jun;42(6):630-8.
• Kimman M, Vathesatogkit P, Woodward M, Tai ES, Thumboo J, Yamwong S, Ratanachaiwong W, Wee HL, Sritara P. Validity of the Thai EQ-5D in an occupational population in Thailand. Qual Life Res. 2013 Aug;22(6):1499-506. doi: 10.1007/s11136-012-0251-2. Epub 2012 Aug 25.
• Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7.
• Csuka M, McCarty DJ. Simple method for measurement of lower extremity muscle strength. Am J Med. 1985 Jan;78(1):77-81.
• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8.
• Chou CY, Chien CW, Hsueh IP, Sheu CF, Wang CH, Hsieh CL. Developing a short form of the Berg Balance Scale for people with stroke. Phys Ther. 2006 Feb;86(2):195-204.
• Hill KD, Schwarz JA, Kalogeropoulos AJ, Gibson SJ. Fear of falling revisited. Arch Phys Med Rehabil. 1996 Oct;77(10):1025-9.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 9, 2015): 439
• Original Estimated Enrollment (submitted: March 17, 2014): 440
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Thai elderly aged 65 years or older
2. able to communicate and follow the home-based exercise programme

3. mild to moderate balance dysfunctions as followings:

   • functional reach test score less than 26 cm.
   • five time sit to stand test more than 17.9 seconds
   • able to walk independently or walk with only single cane
4. non diagnosed with moderate to severe dementia or depression
5. non diagnosed with parkinson disease
6. non diagnosed with cerebrovascular disease with less than grade 4 hemiparesis.
7. non diagnosed with acute arthritis or recent diagnosed within 6 months.
8. informed and consent to participate in the study
9. not participate in regular Tai-chi or Yoga exercise training.

Exclusion criteria:

1. Participants would like to withdraw from the study.
2. severe injury occured after following simple designed exercise program eg. tendon injuries.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT02089815
• Other Study ID Numbers: 01-56-37
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chitima Boongird, Mahidol University
• Study Sponsor: Mahidol University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Chitima Boongird, MD; Department of Family Medicine, Ramathibodi Hospital, Mahidol University

• PRS Account: Mahidol University
• Verification Date: April 2015