Fracture and Fall Prevention in Elderly With Osteoporosis
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 5, 2012
CompletedFirst Posted
Study publicly available on registry
November 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 27, 2012
November 1, 2012
5.9 years
October 5, 2012
November 20, 2012
Conditions
Outcome Measures
Primary Outcomes (3)
Changes of torque demand to capacity ratio 6 months
Change from Baseline intorque demand to capacity ratio at 6 months
Changes of torque demand to capacity ratio at 3 months
Change from Baseline in torque demand to capacity ratio at 3 months
Change of torque demand to capacity ratio at 12months
Change from Baseline in torque demand to capacity ratio at 12 months
Study Arms (1)
Exercise
EXPERIMENTALParticipants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- being pregnant;
- sensory-motor deficits;
- inability of communication
- lack of access to a telephone.
- 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).
- being pregnant;
- sensory-motor deficits;
- inability of communication
- lack of access to a telephone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital
Taipei, Taiwan, 10055, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weili Hsu, PhD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2012
First Posted
November 27, 2012
Study Start
January 1, 2010
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
November 27, 2012
Record last verified: 2012-11