- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616030
Early Strength Training After Hip Fracture Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Hvidovre, Denmark, 2650
- Copenhagen University Hospital, Hvidovre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Strength training, fractured limb
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline to discharge, in average 10 days.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
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Baseline to discharge, in average 10 days.
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Association between 10 meter fast speed walk and knee-extension strength discharge from hospital.
Time Frame: Day before discharge from hospital.
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Day before discharge from hospital.
|
Collaborators and Investigators
Investigators
- Study Director: Morten T Kristensen, PhD, Copenhagen University Hospital at Hvidovre, Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HH-S-1
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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