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Completed

NCT Number: NCT02089815

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

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.

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Key information

Conditions

Patient Fall Fear of Falling Muscle Balance Quality of Life

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Home Based Exercise

Behavioral

modified Otago exercise program to simple designed home based exercise program

Other names: combination strengthening and balance training program

fall prevention education and counseling

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. muscle strength

    Time frame: baseline, 12 weeks and 24 weeks

    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.

  2. 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.)

Other outcomes

  1. fear of falling

    Time frame: baseline and at 24 weeks.

    Thai Falls efficacy scale-international (FES-I)

  2. Quality of life

    Time frame: 1 year

    The participants will be interviewed by using Thai EQ-5D questionaires.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2014
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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