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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Patient Fall Muscle Balance Fear of Falling Quality of Life Behavioral: Home based exercise Other: fall prevention education and counseling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 439 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Home based exercise
simple designed home based exercise program
 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
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
 Other: fall prevention education and counseling


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. 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.

  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089815


Locations
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Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Chitima Boongird, MD Department of Family Medicine, Ramathibodi Hospital, Mahidol University
More Information
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Publications:

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Responsible Party: Chitima Boongird, Doctor, Mahidol University
ClinicalTrials.gov Identifier: NCT02089815    
Other Study ID Numbers: 01-56-37
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015