NCT02089815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
439

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

March 10, 2014

Last Update Submit

April 9, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • muscle strength

    baseline, 12 weeks and 24 weeks

  • Balance

    Baseline, 12 weeks and 24 weeks

Other Outcomes (2)

  • fear of falling

    baseline and at 24 weeks.

  • Quality of life

    1 year

Study Arms (2)

Home based exercise

EXPERIMENTAL

simple designed home based exercise program

Behavioral: Home based exerciseOther: fall prevention education and counseling

fall prevention education and counseling

ACTIVE COMPARATOR

fall prevention education \& counseling : home modification, vision screening, avoid sedative drugs use, proper shoes, report dizziness and fall to doctors

Other: fall prevention education and counseling

Interventions

modified Otago exercise program to simple designed home based exercise program

Also known as: combination strengthening and balance training program
Home based exercise
Home based exercisefall prevention education and counseling

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Thai elderly aged 65 years or older
  • able to communicate and follow the home-based exercise programme
  • 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
  • non diagnosed with moderate to severe dementia or depression
  • non diagnosed with parkinson disease
  • non diagnosed with cerebrovascular disease with less than grade 4 hemiparesis.
  • non diagnosed with acute arthritis or recent diagnosed within 6 months.
  • informed and consent to participate in the study
  • not participate in regular Tai-chi or Yoga exercise training.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi Hospital, Mahidol University

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (18)

  • 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. No abstract available.

    PMID: 21436159BACKGROUND
  • 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.

    PMID: 21594001BACKGROUND
  • 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.

    PMID: 21979272BACKGROUND
  • 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. doi: 10.1136/bmj.315.7115.1065.

    PMID: 9366737BACKGROUND
  • 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.

    PMID: 19093923BACKGROUND
  • 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.

    PMID: 22813920BACKGROUND
  • Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.

    PMID: 22071817BACKGROUND
  • 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.

    PMID: 20817938BACKGROUND
  • 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. doi: 10.1136/bmj.39412.525243.BE. Epub 2007 Dec 18.

    PMID: 18089892BACKGROUND
  • 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.

    PMID: 19370674BACKGROUND
  • 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. doi: 10.1136/bmj.325.7356.128.

    PMID: 12130606BACKGROUND
  • 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. doi: 10.1111/j.1532-5415.1994.tb06862.x.

    PMID: 8201149BACKGROUND
  • 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.

    PMID: 22926727BACKGROUND
  • Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.

    PMID: 2229941BACKGROUND
  • Csuka M, McCarty DJ. Simple method for measurement of lower extremity muscle strength. Am J Med. 1985 Jan;78(1):77-81. doi: 10.1016/0002-9343(85)90465-6.

    PMID: 3966492BACKGROUND
  • 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. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PMID: 1991946BACKGROUND
  • 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.

    PMID: 16445333BACKGROUND
  • Hill KD, Schwarz JA, Kalogeropoulos AJ, Gibson SJ. Fear of falling revisited. Arch Phys Med Rehabil. 1996 Oct;77(10):1025-9. doi: 10.1016/s0003-9993(96)90063-5.

    PMID: 8857881BACKGROUND

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Chitima Boongird, MD

    Department of Family Medicine, Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 18, 2014

Study Start

August 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations