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Patient FallNCT02089815

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

A study testing Home based exercise and fall prevention education and counseling in people with Patient Fall and Muscle Balance, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Patient Fall, Muscle Balance, Fear of Falling
What is being tested?
Home based exercise and fall prevention education and counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
439 participants
Where
1 siteThailand
Study dates
Aug 2013to Mar 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Ramathibodi Hospital, Mahidol University

    Bangkok, Bangkok, 10400

Other trials in Thailand

About this study

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

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.

Being tested
Home based exercise, fall prevention education and counseling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home based exerciseBehavioural

    Also called combination strengthening and balance training program

    modified Otago exercise program to simple designed home based exercise program

  • fall prevention education and counselingOther

Study groups in NCT02089815
Study groupRoleWhat they receive
Home based exerciseExperimentalsimple designed home based exercise program
Receives: Behavioral: Home based exercise; Other: fall prevention education and counseling
fall prevention education and counselingActive comparatorfall prevention education \& counseling : home modification, vision screening, avoid sedative drugs use, proper shoes, report dizziness and fall to doctors
Receives: Other: fall prevention education and counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (2)

  1. muscle strength

    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.

    Measured: baseline, 12 weeks and 24 weeks

  2. Balance

    The participants will be tested their balances by using Short form of Berg Balance scale (7 items, 0-28 scores.)

    Measured: Baseline, 12 weeks and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2014 (estimated)
  2. Study startAug 2013
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02089815
Sponsor's protocol ID
01-56-37
Status last verified
Apr 2015
First submitted
10 Mar 2014
Last updated
13 Apr 2015
Results posted
No
Data monitoring committee
Yes

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. No abstract available.

    PubMed 21436159

  • 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.

    PubMed 21594001

  • 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.

    PubMed 21979272

  • 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.

    PubMed 9366737

  • 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.

    PubMed 19093923

  • 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.

    PubMed 22813920

  • 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.

    PubMed 22071817

  • 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.

    PubMed 20817938

  • 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.

    PubMed 18089892

  • 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.

    PubMed 19370674

  • 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.

    PubMed 12130606

  • 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.

    PubMed 8201149

  • 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.

    PubMed 22926727

  • 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.

    PubMed 2229941

  • 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.

    PubMed 3966492

Questions about this trial

What is this clinical trial studying?

A study testing Home based exercise and fall prevention education and counseling in people with Patient Fall and Muscle Balance, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of falls (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02089815, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.

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