Hip FracturesNCT01616030
Early Strength Training After Hip Fracture Surgery
A study testing Knee-extension strength training of the fractured limb in people with Hip Fractures, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
Patients treated surgically for a hip fracture have a need of rehabilitation for the regain of former functional skills. Despite an optimized fast track in-hospital rehabilitation program it has been found that patients with hip fracture within 2 weeks after the hip fracture loose more than half of their muscle… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Knee-extension strength training of the fractured limb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip fracture diagnosed patients age ≥60 years, admitted to the acute hip fracture unit.
- Medial femoral neck fracture, pertrochanteric fracture or subtrochanteric fracture.
- Ability to speak and understand the Danish language.
- Cognitively well-preserved and able to give personal informed consent no later than by 5th post surgical day.
- Home-residing and with an independent pre-fracture ability to walk equal to New Mobility Score at ≥ 2 indoor.
Who cannot join
- Multiple fractures
- Postsurgical restrictions of mobilization
- Patient not accepting participation in relevant exercise therapy
- Fracture caused by cancer metastases
- Terminal illness
- Neurological impairment e.g. hemi paresis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Progressive Strength Training in the Early Post Surgical Rehabilitation Period After Hip Fracture Surgery
Patients treated surgically for a hip fracture have a need of rehabilitation for the regain of former functional skills. Despite an optimized fast track in-hospital rehabilitation program it has been found that patients with hip fracture within 2 weeks after the hip fracture loose more than half of their muscle strength in the fractured limb compared to non-fractured limb. New studies including patients with total hip arthroplasty and strength training applied early after surgery has shown promising results regarding prevention of loss of muscle strength. No similar study has been found including patients with hip fracture.
The purpose of this study is to examine the feasibility of progressive knee-extension strength training of the hip fractured limb, starting Day 1 after surgical treatment for a hip fracture and proceeded every weekday during their hospital stay.
The study will include 20 patients surgically treated for a cervical hip fracture and 20 patients surgically treated for an intertrochanteric or subtrochanteric fracture. All patients are admitted from their own home. Age 60 years or older.
Read the detailed description
Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT (2014) Feasibility of Progressive Strength Training Implemented in the Acute Ward after Hip Fracture Surgery. PLoS ONE 9(4): e93332. doi:10.1371/journal.pone.0093332
- Conditions
- Hip Fractures
- Being tested
- Knee-extension strength training of the fractured limb
- Keywords
- Hip fractures, Strength training
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee-extension strength training of the fractured limbOther
Daily knee-extension strength training with 3 x 10 repetitions using an intensity of 10 Repetition Maximum (RM) for the hip fractured limb started as soon as possible after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Strength training, fractured limb | Experimental | Knee-extension strength training of the fractured limb:
Daily knee-extension strength training with 3 x 10 repetitions using an intensity of 10 Repetition Maximum (RM) for the hip fractured limb started as soon as possible after surgery. Receives: Other: Knee-extension strength training of the fractured limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of progression in training loads (kg) during daily knee-extension strength training when commenced immediately after hip fracture surgery.
Feasibility is evaluated on the basis of adherence to program, adverse events, target training intensity, hip pain during training and other potential restricting factors, e.g. confusion, exhaustion and dropouts.
Measured: Baseline to discharge, in average 10 days.
Secondary outcomes (1)
Change in maximum isometric knee-extension strength and strength deficits, fractured % of non-fractured limb measured by handheld dynamometer.
Measured: Baseline to discharge, in average 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2013
- Study completionMar 2013
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 FracturesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lise Kronborg, Copenhagen University Hospital, Hvidovre
- Investigators
- Morten T Kristensen, PhD, Study director, Copenhagen University Hospital at Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616030
- Sponsor's protocol ID
- HH-S-1
- Status last verified
- May 2014
- First submitted
- 5 Jun 2012
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT. Feasibility of progressive strength training implemented in the acute ward after hip fracture surgery. PLoS One. 2014 Apr 3;9(4):e93332. doi: 10.1371/journal.pone.0093332. eCollection 2014.
PubMed 24699276
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Progressive Strength Training in the Early Post Surgical Rehabilitation Period After Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT01616030
- Acronym / sponsor ID
- HH-S-1
- Conditions
- Hip Fractures
- Keywords
- Hip fractures, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Jun 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.
Patients treated surgically for a hip fracture have a need of rehabilitation for the regain of former functional skills. Despite an optimized fast track in-hospital rehabilitation program it has been found that patients with hip fracture within 2 weeks after the hip fracture loose more than half of their muscle strength in the fractured limb compared to non-fractured limb. New studies including patients with total hip arthroplasty and strength training applied early after surgery has shown promising results regarding prevention of loss of muscle strength. No similar study has been found including patients with hip fracture.
The purpose of this study is to examine the feasibility of progressive knee-extension strength training of the hip fractured limb, starting Day 1 after surgical treatment for a hip fracture and proceeded every weekday during their hospital stay.
The study will include 20 patients surgically treated for a cervical hip fracture and 20 patients surgically treated for an intertrochanteric or subtrochanteric fracture. All patients are admitted from their own home. Age 60 years or older.
Detailed description
Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT (2014) Feasibility of Progressive Strength Training Implemented in the Acute Ward after Hip Fracture Surgery. PLoS ONE 9(4): e93332. doi:10.1371/journal.pone.0093332
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strength training, fractured limb | Experimental | Other: Knee-extension strength training of the fractured limbKnee-extension strength training of the fractured limb: Daily knee-extension strength training with 3 x 10 repetitions using an intensity of 10 Repetition Maximum (RM) for the hip fractured limb started as soon as possible after surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hip fracture diagnosed patients age ≥60 years, admitted to the acute hip fracture unit.
- Medial femoral neck fracture, pertrochanteric fracture or subtrochanteric fracture.
- Ability to speak and understand the Danish language.
- Cognitively well-preserved and able to give personal informed consent no later than by 5th post surgical day.
- Home-residing and with an independent pre-fracture ability to walk equal to New Mobility Score at ≥ 2 indoor.
Key exclusion criteria (6 listed)
- Multiple fractures
- Postsurgical restrictions of mobilization
- Patient not accepting participation in relevant exercise therapy
- Fracture caused by cancer metastases
- 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 |
|---|---|---|
| Knee-extension strength training of the fractured limbDaily knee-extension strength training with 3 x 10 repetitions using an intensity of 10 Repetition Maximum (RM) for the hip fractured limb started as soon as possible after surgery. | Other | Strength training, fractured limb |
Primary outcome
Feasibility of progression in training loads (kg) during daily knee-extension strength training when commenced immediately after hip fracture surgery.
Time frame: Baseline to discharge, in average 10 days.
Feasibility is evaluated on the basis of adherence to program, adverse events, target training intensity, hip pain during training and other potential restricting factors, e.g. confusion, exhaustion and dropouts.
1 secondary outcome
Change in maximum isometric knee-extension strength and strength deficits, fractured % of non-fractured limb measured by handheld dynamometer.
Time frame: Baseline to discharge, in average 10 days.
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 15 May 2014.
- Results publication: PubMed 24699276Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT. Feasibility of progressive strength training implemented in the acute ward after hip fracture surgery. PLoS One. 2014 Apr 3;9(4):e93332. doi: 10.1371/journal.pone.0093332. eCollection 2014.
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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.
Morten T Kristensen, PhD study director
Copenhagen University Hospital at Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee-extension strength training of the fractured limb in people with Hip Fractures, run by Copenhagen University Hospital, Hvidovre 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 6 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 15 May 2014. 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?
Feasibility of progression in training loads (kg) during daily knee-extension strength training when commenced immediately after hip fracture surgery. (time frame: Baseline to discharge, in average 10 days.). 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 NCT01616030, 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 15 May 2014; AzTrials last refreshed its copy on 2 Nov 2026.