Hip FractureNCT00848913
Strength Training After Hip Fracture Surgery
A study testing Rehabilitation with strength training and Rehabilitation without strength training in people with Hip Fracture, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the effect of progressive strength training of the fractured limb in patients with hip fracture, during admittance in an acute orthopedic ward. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Rehabilitation with strength training and Rehabilitation without strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Jun 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Primary hip fracture surgery
- 65 years or older
- Speak and understand the Danish language
- Able to give informed consent
- Home-dwelling with and independent prefracture indoor walking ability equal to New Mobility Score >=2
Who cannot join
- Multiple fractures
- Weightbearing restrictions
- Patient unwilling to participate in appropriate rehabilitation
- Not able to cooperate to tests
- Terminal illness
- Patients who want an observer present at the information interview, but where such one is not available.
- Patients with a cervical hip fracture treated with Total Hip Arthroplasty or hip pins, due to expected short length of hospital stay.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Orthopedic Surgery hvidovre hospital
Hvidovre, Copenhagen, 2650
About this study
Official title: Effect of Rehabilitation With Versus Without Progressive Strength Training Implemented in the Acute Ward After Hip Fracture Surgery: A Randomized Controlled Trial
The purpose of this study is to examine the effect of progressive strength training of the fractured limb in patients with hip fracture, during admittance in an acute orthopedic ward. The primary study hypothesis is that the training will reduce the strength deficit in the fractured limb in comparison with the non-fractured limb. Secondary, that patients following the intervention will present larger improvements in physical function compared to controls.
- Conditions
- Hip Fracture
- Being tested
- Rehabilitation with strength training, Rehabilitation without strength training
- Keywords
- strength deficit, physical function
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation with strength trainingOther
Basic mobility and exercise therapy following a guideline with 12 specific exercises, progressed individually, and supplemented with progressive knee-extension strength training (10RM) of the fractured limb using ankle weight cuffs, daily during hospital stay.
Rehabilitation without strength trainingOther
Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation without strength training | Active comparator | Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually. Receives: Other: Rehabilitation without strength training |
| Rehabilitation with strength training | Experimental | Basic mobility and exercise therapy following a guideline with 12 specific exercises, progressed individually, and supplemented with progressive knee-extension strength training (10RM) of fractured limb every day during admission. Receives: Other: Rehabilitation with strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee-extension strength in the fractured limb in comparison with the non-fractured limb.
Maximal isometric knee-extension strength in the fractured limb in percentage of non-fractured limb. Isometric knee-extension strength will be measured using an externally fixated handheld dynamometer (Power Track II Commander; JTech Medical, Utah). A stap will be attached to the bed/chair and the patient's ankle (perpendicular to the lower leg), ensuring 90 degrees of knee flexion and an isometric contraction. The transducer will be placed under the strap at ankle level, just proximal to the malleolus, and the participant will be asked to extend the leg as forcefully as possible. Knee-extension strength will be expressed as the maximal voluntary torque per kilo body mass ([NIm]/kg), using the distance between the lateral femoral epicondyle and the center of the transducer and the body mass of each patient. The best of 4 trials for each limb will be used in analyses. The primary analysis will follow the intention-to-treat principle (last observation carried forward).
Measured: At inclusion, at postoperative day 10 and/or at discharge.
Secondary outcomes (1)
Timed up and go test
Timed Up and Go test is assessed as early as possible during in-hospital stay and at discharge.
Measured: From inclusion to postoperative day 10 and/or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Tange Kristensen, Hvidovre University Hospital
- Investigators
- Lise Kronborg, MSc, Principal investigator, PMR-C, Copenhagen University at Hvidovre Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848913
- Sponsor's protocol ID
- H-A-2007-0127 + 37036
- Status last verified
- Jun 2015
- First submitted
- 19 Feb 2009
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT. Effectiveness of acute in-hospital physiotherapy with knee-extension strength training in reducing strength deficits in patients with a hip fracture: A randomised controlled trial. PLoS One. 2017 Jun 29;12(6):e0179867. doi: 10.1371/journal.pone.0179867. eCollection 2017.
PubMed 28662153
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rehabilitation With Versus Without Progressive Strength Training Implemented in the Acute Ward After Hip Fracture Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00848913
- Acronym / sponsor ID
- H-A-2007-0127 + 37036
- Conditions
- Hip Fracture
- Keywords
- strength deficit, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Feb 2009 (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.
The purpose of this study is to examine the effect of progressive strength training of the fractured limb in patients with hip fracture, during admittance in an acute orthopedic ward. The primary study hypothesis is that the training will reduce the strength deficit in the fractured limb in comparison with the non-fractured limb. Secondary, that patients following the intervention will present larger improvements in physical function compared to controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation without strength training | Active comparator | Other: Rehabilitation without strength trainingBasic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually. |
| Rehabilitation with strength training | Experimental | Other: Rehabilitation with strength trainingBasic mobility and exercise therapy following a guideline with 12 specific exercises, progressed individually, and supplemented with progressive knee-extension strength training (10RM) of fractured limb every day during admission. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Primary hip fracture surgery
- 65 years or older
- Speak and understand the Danish language
- Able to give informed consent
- Home-dwelling with and independent prefracture indoor walking ability equal to New Mobility Score >=2
Key exclusion criteria (7 listed)
- Multiple fractures
- Weightbearing restrictions
- Patient unwilling to participate in appropriate rehabilitation
- Not able to cooperate to tests
- Terminal illness
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 |
|---|---|---|
| Rehabilitation with strength trainingBasic mobility and exercise therapy following a guideline with 12 specific exercises, progressed individually, and supplemented with progressive knee-extension strength training (10RM) of the fractured limb using ankle weight cuffs, daily during hospital stay. | Other | Rehabilitation with strength training |
| Rehabilitation without strength trainingBasic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually. | Other | Rehabilitation without strength training |
Primary outcome
Knee-extension strength in the fractured limb in comparison with the non-fractured limb.
Time frame: At inclusion, at postoperative day 10 and/or at discharge.
Maximal isometric knee-extension strength in the fractured limb in percentage of non-fractured limb. Isometric knee-extension strength will be measured using an externally fixated handheld dynamometer (Power Track II Commander; JTech Medical, Utah). A stap will be attached to the bed/chair and the patient's ankle (perpendicular to the lower leg), ensuring 90 degrees of knee flexion and an isometric contraction. The transducer will be placed under the strap at ankle level, just proximal to the malleolus, and the participant will be asked to extend the leg as forcefully as possible. Knee-extension strength will be expressed as the maximal voluntary torque per kilo body mass ([NIm]/kg), using the distance between the lateral femoral epicondyle and the center of the transducer and the body mass of each patient. The best of 4 trials for each limb will be used in analyses. The primary analysis will follow the intention-to-treat principle (last observation carried forward).
1 secondary outcome
Timed up and go test
Time frame: From inclusion to postoperative day 10 and/or discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 28662153Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT. Effectiveness of acute in-hospital physiotherapy with knee-extension strength training in reducing strength deficits in patients with a hip fracture: A randomised controlled trial. PLoS One. 2017 Jun 29;12(6):e0179867. doi: 10.1371/journal.pone.0179867. eCollection 2017.
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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.
Lise Kronborg, MSc principal investigator
PMR-C, Copenhagen University at Hvidovre 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 Rehabilitation with strength training and Rehabilitation without strength training in people with Hip Fracture, run by Hvidovre University Hospital at 1 site in Denmark.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 3 Jun 2015. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee-extension strength in the fractured limb in comparison with the non-fractured limb. (time frame: At inclusion, at postoperative day 10 and/or at discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848913, which also lists 1 linked publication.
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 3 Jun 2015.