Fracture and Fall Prevention in Elderly With Osteoporosis
Primary Purpose
Osteoporosis
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
personalized core muscle training program
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
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.
Sites / Locations
- Physical Therapy Center or the Orthopedic Center in the National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
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.
Outcomes
Primary Outcome Measures
Changes of torque demand to capacity ratio 6 months
Changes of torque demand to capacity ratio at 3 months
Change of torque demand to capacity ratio at 12months
Secondary Outcome Measures
Full Information
NCT ID
NCT01733303
First Posted
October 5, 2012
Last Updated
November 20, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01733303
Brief Title
Fracture and Fall Prevention in Elderly With Osteoporosis
Official Title
Fracture and Fall Prevention in Elderly With Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
personalized core muscle training program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of torque demand to capacity ratio 6 months
Time Frame
Change from Baseline intorque demand to capacity ratio at 6 months
Title
Changes of torque demand to capacity ratio at 3 months
Time Frame
Change from Baseline in torque demand to capacity ratio at 3 months
Title
Change of torque demand to capacity ratio at 12months
Time Frame
Change from Baseline in torque demand to capacity ratio at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Hsu, PhD
Phone
886-2-3366-8127
Email
wlhsu@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Hsu, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10055
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Hsu, PhD
Phone
886-2-3366-8127
Email
wlhsu@ntu.edu.tw
12. IPD Sharing Statement
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Fracture and Fall Prevention in Elderly With Osteoporosis
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