- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848913
Strength Training After Hip Fracture Surgery
June 2, 2015 updated by: Morten Tange Kristensen, Hvidovre University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen
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Hvidovre, Copenhagen, Denmark, 2650
- Department of Orthopedic Surgery hvidovre hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rehabilitation without strength training
Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.
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Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.
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Experimental: Rehabilitation with strength training
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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).
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At inclusion, at postoperative day 10 and/or at discharge.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed up and go test
Time Frame: From inclusion to postoperative day 10 and/or discharge
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Timed Up and Go test is assessed as early as possible during in-hospital stay and at discharge.
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From inclusion to postoperative day 10 and/or discharge
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10 meter fast speed, Cumulated Ambulation Score.
Time Frame: At discharge and during in-hospital stay.
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Cumulated Ambulation Score is recorded every day from inclusion to discharge.
10 meter fast speed is assessed at postoperative day 10 and/or discharge.
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At discharge and during in-hospital stay.
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Short Falls Efficacy Scale-International (Short FES-I)
Time Frame: At discharge
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A questionnaire evaluation of the patient's subjective concern at the moment for falling related to 7 different physical functions.
Score 7-28, with maximum score expressing very high concern of falling in all 7 physical functions.
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At discharge
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Verbal Ranking Scale (VRS)
Time Frame: During in-hospital stay.
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Evaluation of experienced hip-fracture related pain at rest and during strength training and testing.
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During in-hospital stay.
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24-hour activity
Time Frame: From inclusion to discharge
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24-hour sit/lie and stand/walk activity measured by a ActivPAL3 activity monitor (PAL Technologies Ltd, Scotland) attached to the patient's non-fractured thigh.
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From inclusion to discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lise Kronborg, MSc, PMR-C, Copenhagen University at Hvidovre Hospital.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Estimate)
June 3, 2015
Last Update Submitted That Met QC Criteria
June 2, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-A-2007-0127 + 37036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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