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

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT02089815
Collaborator
(none)
439
Enrollment
1
Location
2
Arms
19
Duration (Months)
23.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Home based exercise
  • Other: fall prevention education and counseling
 N/A

Study Design

Study Type:
Interventional
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 :
Aug 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

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 Names:
  • 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

    Primary Outcome Measures

    1. number of falls [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 [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 [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 [baseline and at 24 weeks.]

      Thai Falls efficacy scale-international (FES-I)

    2. Quality of life [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. non diagnosed with moderate to severe dementia or depression

    2. non diagnosed with parkinson disease

    3. non diagnosed with cerebrovascular disease with less than grade 4 hemiparesis.

    4. non diagnosed with acute arthritis or recent diagnosed within 6 months.

    5. informed and consent to participate in the study

    6. 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

    Locations

    Site City State Country Postal Code
    1 Ramathibodi Hospital, Mahidol University Bangkok Thailand 10400

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Chitima Boongird, MD, Department of Family Medicine, Ramathibodi Hospital, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chitima Boongird, Doctor, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT02089815
    Other Study ID Numbers:
    • 01-56-37
    First Posted:
    Mar 18, 2014
    Last Update Posted:
    Apr 13, 2015
    Last Verified:
    Apr 1, 2015

    Study Results

    No Results Posted as of Apr 13, 2015