NCT00848913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
4.6 years until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

February 19, 2009

Last Update Submit

June 2, 2015

Conditions

Keywords

strength deficitphysical function

Outcome Measures

Primary Outcomes (1)

  • 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).

    At inclusion, at postoperative day 10 and/or at discharge.

Secondary Outcomes (1)

  • Timed up and go test

    From inclusion to postoperative day 10 and/or discharge

Other Outcomes (4)

  • 10 meter fast speed, Cumulated Ambulation Score.

    At discharge and during in-hospital stay.

  • Short Falls Efficacy Scale-International (Short FES-I)

    At discharge

  • Verbal Ranking Scale (VRS)

    During in-hospital stay.

  • +1 more other outcomes

Study Arms (2)

Rehabilitation without strength training

ACTIVE COMPARATOR

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

Other: Rehabilitation without strength training

Rehabilitation with strength training

EXPERIMENTAL

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.

Other: Rehabilitation with strength training

Interventions

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.

Rehabilitation with strength training

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

Rehabilitation without strength training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Primary hip fracture surgery
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedic Surgery hvidovre hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hip Fractures

Interventions

RehabilitationResistance Training

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesExercise TherapyPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lise Kronborg, MSc

    PMR-C, Copenhagen University at Hvidovre Hospital.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seniorresearcher, PhD

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

October 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations