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Strength Training After Hip Fracture Surgery

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Rehabilitation with strength training
Rehabilitation without strength training
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring strength deficit, physical function

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Orthopedic Surgery hvidovre hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rehabilitation without strength training

Rehabilitation with strength training

Arm Description

Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Timed up and go test
Timed Up and Go test is assessed as early as possible during in-hospital stay and at discharge.

Full Information

First Posted
February 19, 2009
Last Updated
June 2, 2015
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00848913
Brief Title
Strength Training After Hip Fracture Surgery
Official Title
Effect of Rehabilitation With Versus Without Progressive Strength Training Implemented in the Acute Ward After Hip Fracture Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
strength deficit, physical function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation without strength training
Arm Type
Active Comparator
Arm Description
Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.
Arm Title
Rehabilitation with strength training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitation with strength training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitation without strength training
Intervention Description
Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.
Primary Outcome Measure Information:
Title
Knee-extension strength in the fractured limb in comparison with the non-fractured limb.
Description
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).
Time Frame
At inclusion, at postoperative day 10 and/or at discharge.
Secondary Outcome Measure Information:
Title
Timed up and go test
Description
Timed Up and Go test is assessed as early as possible during in-hospital stay and at discharge.
Time Frame
From inclusion to postoperative day 10 and/or discharge
Other Pre-specified Outcome Measures:
Title
10 meter fast speed, Cumulated Ambulation Score.
Description
Cumulated Ambulation Score is recorded every day from inclusion to discharge. 10 meter fast speed is assessed at postoperative day 10 and/or discharge.
Time Frame
At discharge and during in-hospital stay.
Title
Short Falls Efficacy Scale-International (Short FES-I)
Description
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.
Time Frame
At discharge
Title
Verbal Ranking Scale (VRS)
Description
Evaluation of experienced hip-fracture related pain at rest and during strength training and testing.
Time Frame
During in-hospital stay.
Title
24-hour activity
Description
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.
Time Frame
From inclusion to discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise Kronborg, MSc
Organizational Affiliation
PMR-C, Copenhagen University at Hvidovre Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedic Surgery hvidovre hospital
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28662153
Citation
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.
Results Reference
derived

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Strength Training After Hip Fracture Surgery

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