- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01733303
Fracture and Fall Prevention in Elderly With Osteoporosis
November 20, 2012 updated by: National Taiwan University Hospital
Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality.
Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention.
Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults.
People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls.
Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis.
The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 10055
- Recruiting
- Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital
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Contact:
- Weili Hsu, PhD
- Phone Number: 886-2-3366-8127
- Email: wlhsu@ntu.edu.tw
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
The inclusion criteria for osteopenia or osteoporosis group:
- able to stand and walk for 5 minutes independently;
- having normal or corrected to normal vision;
- having age between > 50 years
- with osteopenia (-2.5 < t-score < -1.0) or osteoporosis (t-score <-2.5).
The exclusion criteria for osteopenia or osteoporosis group:
- being pregnant;
- sensory-motor deficits;
- inability of communication
- lack of access to a telephone.
The inclusion criteria for control age-matched group:
- able to stand and walk for 5 minutes independently;
- having normal or corrected to normal vision;
- having age between > 50 years
- without osteopenia or osteoporosis (t-score > -1.0).
The exclusion criteria for control age-matched group:
- being pregnant;
- sensory-motor deficits;
- inability of communication
- lack of access to a telephone.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality.
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Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality.
The program will run for 3 months with patients attending for one hour three times a week.
The age-matched control group will maintain their usual daily life activities without any specific instruction.
The exercise training will be run by an experienced physiotherapist, who will encourage patients individually to progress at their own pace.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes of torque demand to capacity ratio 6 months
Time Frame: Change from Baseline intorque demand to capacity ratio at 6 months
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Change from Baseline intorque demand to capacity ratio at 6 months
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Changes of torque demand to capacity ratio at 3 months
Time Frame: Change from Baseline in torque demand to capacity ratio at 3 months
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Change from Baseline in torque demand to capacity ratio at 3 months
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Change of torque demand to capacity ratio at 12months
Time Frame: Change from Baseline in torque demand to capacity ratio at 12 months
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Change from Baseline in torque demand to capacity ratio at 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Weili Hsu, PhD, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
October 5, 2012
First Submitted That Met QC Criteria
November 20, 2012
First Posted (Estimate)
November 27, 2012
Study Record Updates
Last Update Posted (Estimate)
November 27, 2012
Last Update Submitted That Met QC Criteria
November 20, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201003065R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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