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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

Tracking Information
First Submitted Date  ICMJE March 10, 2014
First Posted Date  ICMJE March 18, 2014
Last Update Posted Date April 13, 2015
Study Start Date  ICMJE August 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
  • 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.
  • 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.)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 17, 2014)
  • fear of falling [ Time Frame: baseline and at 24 weeks. ]
    Thai Falls efficacy scale-international (FES-I)
  • Quality of life [ Time Frame: 1 year ]
    The participants will be interviewed by using Thai EQ-5D questionaires.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Home Based Exercise in Preventing Fall and Improving Balance in Older People
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Patient Fall
  • Muscle Balance
  • Fear of Falling
  • Quality of Life
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Home based exercise
    simple designed home based exercise program
    Interventions:
    • Behavioral: Home based exercise
    • 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
    Intervention: Other: fall prevention education and counseling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2015)
439
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2014)
440
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02089815
Other Study ID Numbers  ICMJE 01-56-37
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chitima Boongird, Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chitima Boongird, MD Department of Family Medicine, Ramathibodi Hospital, Mahidol University
PRS Account Mahidol University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP