Hip FracturePhase 2NCT01174589
Training of Patients With Hip Fracture
A Phase 2 study testing Strength training in people with Hip Fracture, run by Lolland Community, Denmark at 1 site in Denmark.
Trial summary
The primary purpose of this study is to illustrate whether there is a difference in the 6 minutes walking test in patients with hip fractures who have received 6 vs. 12 weeks of physical training after discharge from hospital. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Jun 2014
- Phase
- Phase 2
- 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
- patients with hip fractures
- full weightbearing on the affected leg
- patients living in their own home with an independent walking ability score >=2 according to the New Mobility Score scale
- written consent
Who cannot join
- institutionalized patients
- more than 2 weeks after discharge from hospital
- non weight bearing on the affected leg
- Dementia
- other conditions/diagnosis that would have an effect on the ability to train eg. neurological diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strength Training of Patients With Hip Fracture - a Randomized Clinical Trial
The primary purpose of this study is to illustrate whether there is a difference in the 6 minutes walking test in patients with hip fractures who have received 6 vs. 12 weeks of physical training after discharge from hospital.
- Conditions
- Hip Fracture
- Being tested
- Strength training
- Keywords
- Lower limb strength training, Randomized clinical trial, Patients with Hip fracture, 6 vs. 12 weeks physical 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.
Strength trainingOther
to compare if there is a difference between 6 or 12 weeks of physical strength training
| Study group | Role | What they receive |
|---|---|---|
| 6 weeks of physical training | Other | The 6 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week. Receives: Other: Strength training |
| 12 weeks of physical exercise | Other | The 12 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week. Receives: Other: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the 6-minutes walking test
The 6-minutes walking test, performed according to international guidelines.
Measured: at baseline, 6 weeks, 12 weeks (primary analysis) and 24 weeks after baseline testing
Secondary outcomes (5)
Difference of the Maximal isometric knee-extension strength of the fractured limb.
The best of 5 maximal isometric unilateral knee-extension strength tests of both limbs, measured with a fixated handheld dynamometer
Measured: Baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Difference in 10-meter fast speed walking test
Best of 3 timed 10 meter fast speed walk tests.
Measured: At baseline, 6 weeks, 12 weeks, and 24 weeks after baseline testing
Difference in the Timed Up & Go test
Best of 3 timed TUG tests will be used.
Measured: At baseline and 6 weeks, 12 weeks and 24 weeks after baseline testing
Difference in the Short Form-36
The Questionnaire will be filled out during an interview with the patient
Measured: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Difference in the New Mobility Score
The questionnaire will be filled out during an interview with the patient.
Measured: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lolland Community, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Association of Danish Physiotherapists, Copenhagen University Hospital, Hvidovre
- Responsible party
- Principal investigator, Mr. Jan Overgaard, Lolland Community, Denmark
- Investigators
- Jan Overgaard, MSc., Principal investigator, Sector of health, rehabilitation, Lolland community, DenmarkMorten T Kristensen, PhD, Study director, Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174589
- Sponsor's protocol ID
- SJ-145
- Status last verified
- Aug 2014
- First submitted
- 21 Jul 2010
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
PubMed 36070134Overgaard JA, Kallemose T, Mangione KK, Kristensen MT. Six Versus 12 Weeks of Outpatient Physical Therapy Including Progressive Resistance Training in Cognitively Intact Older Adults After Hip Fracture: A Multicenter Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2022 Jul 5;77(7):1455-1462. doi: 10.1093/gerona/glab256.
PubMed 34460897
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training of Patients With Hip Fracture - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01174589
- Acronym / sponsor ID
- SJ-145
- Conditions
- Hip Fracture
- Keywords
- Lower limb strength training, Randomized clinical trial, Patients with Hip fracture, 6 vs. 12 weeks physical strength training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lolland Community, DenmarkUniversity, hospital or other
- Collaborators
- Association of Danish Physiotherapists, Copenhagen University Hospital, Hvidovre
- Study start
- Sep 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Aug 2010 (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 primary purpose of this study is to illustrate whether there is a difference in the 6 minutes walking test in patients with hip fractures who have received 6 vs. 12 weeks of physical training after discharge from hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 weeks of physical training | Other | Other: Strength trainingThe 6 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week. |
| 12 weeks of physical exercise | Other | Other: Strength trainingThe 12 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with hip fractures
- full weightbearing on the affected leg
- patients living in their own home with an independent walking ability score >=2 according to the New Mobility Score scale
- written consent
Key exclusion criteria (5 listed)
- institutionalized patients
- more than 2 weeks after discharge from hospital
- non weight bearing on the affected leg
- Dementia
- other conditions/diagnosis that would have an effect on the ability to train eg. neurological diagnosis
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 |
|---|---|---|
| Strength trainingto compare if there is a difference between 6 or 12 weeks of physical strength training | Other | 12 weeks of physical exercise, 6 weeks of physical training |
Primary outcome
Difference in the 6-minutes walking test
Time frame: at baseline, 6 weeks, 12 weeks (primary analysis) and 24 weeks after baseline testing
The 6-minutes walking test, performed according to international guidelines.
5 secondary outcomes
Difference of the Maximal isometric knee-extension strength of the fractured limb.
Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Difference in 10-meter fast speed walking test
Time frame: At baseline, 6 weeks, 12 weeks, and 24 weeks after baseline testing
Difference in the Timed Up & Go test
Time frame: At baseline and 6 weeks, 12 weeks and 24 weeks after baseline testing
Difference in the Short Form-36
Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Difference in the New Mobility Score
Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
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 7 Aug 2014.
- Derived from this study: PubMed 36070134Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
- Derived from this study: PubMed 34460897Overgaard JA, Kallemose T, Mangione KK, Kristensen MT. Six Versus 12 Weeks of Outpatient Physical Therapy Including Progressive Resistance Training in Cognitively Intact Older Adults After Hip Fracture: A Multicenter Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2022 Jul 5;77(7):1455-1462. doi: 10.1093/gerona/glab256.
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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.
Jan Overgaard, MSc. principal investigator
Sector of health, rehabilitation, Lolland community, Denmark
Morten T Kristensen, PhD study director
Department of Physical Therapy and Orthopedic Surgery, 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 Phase 2 study testing Strength training in people with Hip Fracture, run by Lolland Community, Denmark 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 4 inclusion and 5 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 7 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference in the 6-minutes walking test (time frame: at baseline, 6 weeks, 12 weeks (primary analysis) and 24 weeks after baseline testing). 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 NCT01174589, which also lists 2 linked publications.
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 7 Aug 2014.