Clinical trial NCT02089815: Home Based Exercise in Preventing Fall and Improving Balance in Older People
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Fall
Muscle Balance
Fear of Falling
Quality of Life
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 439
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: number of falls
timeFrame: 1 year
Secondary outcomes:
measure: muscle strength
timeFrame: baseline, 12 weeks and 24 weeks
measure: Balance
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
measure: fear of falling
timeFrame: baseline and at 24 weeks.
measure: Quality of life
timeFrame: 1 year
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: Department of Family Medicine, Ramathibodi Hospital, Mahidol University
name: Chitima Boongird, MD
role: PRINCIPAL_INVESTIGATOR
References:
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