Hip FractureNCT00795028
Preventing Falls and Disability in Older Adults After Hip Fracture
A study of Hip Fracture, run by University of British Columbia.
Trial summary
Patients who have suffered a first hip fracture have a higher risk of falling and sustaining another hip fracture compared with age-matched adults who did not fracture. Although exercise is key to reversing this pattern, there have been very few trials that aimed to improve muscle strength and balance as well as… Read more about this study
- Who is it for?
- Ages 65 to 105 years, women only
- Conditions the study is for
- Hip Fracture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Mar 2013
- 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 65 to 105 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Older community dwelling women who have sustained a first hip fracture
Who cannot join
None listed.
About this study
Patients who have suffered a first hip fracture have a higher risk of falling and sustaining another hip fracture compared with age-matched adults who did not fracture. Although exercise is key to reversing this pattern, there have been very few trials that aimed to improve muscle strength and balance as well as enhance bone health following hip fracture. Therefore, we propose to conduct an RCT that delivers either 12 months of standard care or standard care plus graduated exercise program for older women who have sustained a recent hip fracture.
- Conditions
- Hip Fracture
- Being tested
- Standard Care for people after hip fracture, Standard Care + exercise intervention
- Keywords
- older women, hip fracture, exercise intervention
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care for people after hip fractureOther
Standard Care + exercise interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard Care for people after a hip fracture Receives: Other: Standard Care for people after hip fracture |
| 2 | Experimental | Standard Care + exercise intervention Receives: Other: Standard Care + exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall rate, measured by self-reported daily fall diaries, will be collected monthly at the exercise classes and followed up by an independent investigator
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maureen C. Ashe, University of British Columbia
- Investigators
- M C Ashe, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795028
- Sponsor's protocol ID
- H08-01685
- Status last verified
- Apr 2023
- First submitted
- 20 Nov 2008
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Falls and Disability in Older Adults After Hip Fracture
- ClinicalTrials.gov ID
- NCT00795028
- Acronym / sponsor ID
- H08-01685
- Conditions
- Hip Fracture
- Keywords
- older women, hip fracture, exercise intervention
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Nov 2008 (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.
Patients who have suffered a first hip fracture have a higher risk of falling and sustaining another hip fracture compared with age-matched adults who did not fracture. Although exercise is key to reversing this pattern, there have been very few trials that aimed to improve muscle strength and balance as well as enhance bone health following hip fracture. Therefore, we propose to conduct an RCT that delivers either 12 months of standard care or standard care plus graduated exercise program for older women who have sustained a recent hip fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Standard Care for people after hip fractureStandard Care for people after a hip fracture |
| 2 | Experimental | Other: Standard Care + exercise interventionStandard Care + exercise intervention |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Older community dwelling women who have sustained a first hip fracture
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standard Care for people after hip fracture | Other | 1 |
| Standard Care + exercise intervention | Other | 2 |
Primary outcome
Fall rate, measured by self-reported daily fall diaries, will be collected monthly at the exercise classes and followed up by an independent investigator
Time frame: Monthly
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
Related trials for Hip Fracture
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
M C Ashe, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study of Hip Fracture, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall rate, measured by self-reported daily fall diaries, will be collected monthly at the exercise classes and followed up by an independent investigator (time frame: Monthly). 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 28 Apr 2023.