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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089815
• Other study ID #: 01-56-37
• Status: Completed
• Phase: N/A
• First received: March 10, 2014
• Last updated: April 9, 2015
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Home based exercise
modified Otago exercise program to simple designed home based exercise program

Other:
• fall prevention education and counseling

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (18)

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. — View Citation

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. — View Citation

Csuka M, McCarty DJ. Simple method for measurement of lower extremity muscle strength. Am J Med. 1985 Jan;78(1):77-81. — View Citation

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. — View Citation

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. — View Citation

Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hill KD, Schwarz JA, Kalogeropoulos AJ, Gibson SJ. Fear of falling revisited. Arch Phys Med Rehabil. 1996 Oct;77(10):1025-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):262-75. doi: 10.1016/j.ypmed.2012.07.007. Epub 2012 Jul 17. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fear of falling	Thai Falls efficacy scale-international (FES-I)	baseline and at 24 weeks.	No
Other	Quality of life	The participants will be interviewed by using Thai EQ-5D questionaires.	1 year	No
Primary	number of falls	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.	1 year	No
Secondary	muscle strength	There are two Measurements as following: 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.; Timed up and go test The time required to rise from a chair, walk 3 meters distance, turn around, walk back and sit down.	baseline, 12 weeks and 24 weeks	No
Secondary	Balance	The participants will be tested their balances by using Short form of Berg Balance scale (7 items, 0-28 scores.)	Baseline, 12 weeks and 24 weeks	No