OsteoporosisNCT01733303
Fracture and Fall Prevention in Elderly With Osteoporosis
A study testing personalized core muscle training program in people with Osteoporosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- personalized core muscle training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital
Taipei, Taiwan, 10055
Weili Hsu, PhD, 886-2-3366-8127, wlhsu@ntu.edu.tw
About this study
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.
- Conditions
- Osteoporosis
- Being tested
- personalized core muscle training program
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized core muscle training programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 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. Receives: Behavioral: personalized core muscle training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of torque demand to capacity ratio 6 months
Measured: Change from Baseline intorque demand to capacity ratio at 6 months
Changes of torque demand to capacity ratio at 3 months
Measured: Change from Baseline in torque demand to capacity ratio at 3 months
Change of torque demand to capacity ratio at 12months
Measured: Change from Baseline in torque demand to capacity ratio at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weili Hsu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733303
- Sponsor's protocol ID
- 201003065R
- Status last verified
- Nov 2012
- First submitted
- 5 Oct 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fracture and Fall Prevention in Elderly With Osteoporosis
- ClinicalTrials.gov ID
- NCT01733303
- Acronym / sponsor ID
- 201003065R
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: personalized core muscle training programParticipants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personalized core muscle training programParticipants 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. | Behavioural | Exercise |
Primary outcome
Changes of torque demand to capacity ratio 6 months
Time frame: Change from Baseline intorque demand to capacity ratio at 6 months
Changes of torque demand to capacity ratio at 3 months
Time frame: Change from Baseline in torque demand to capacity ratio at 3 months
Change of torque demand to capacity ratio at 12months
Time frame: Change from Baseline in torque demand to capacity ratio at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weili Hsu, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized core muscle training program in people with Osteoporosis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Hsu, PhD (886-2-3366-8127, wlhsu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of torque demand to capacity ratio 6 months (time frame: Change from Baseline intorque demand to capacity ratio at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.