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Completed

NCT Number: NCT00848913

Strength Training After Hip Fracture Surgery

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.

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Key information

Conditions

Hip Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopedic Surgery hvidovre hospital

Hvidovre, Copenhagen, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rehabilitation with strength training

Other

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 without strength training

Other

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

Primary outcomes

  1. 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.

    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 outcomes

  1. Timed up and go test

    Time frame: From inclusion to postoperative day 10 and/or discharge

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

Other outcomes

  1. 10 meter fast speed, Cumulated Ambulation Score.

    Time frame: At discharge and during in-hospital stay.

    Cumulated Ambulation Score is recorded every day from inclusion to discharge. 10 meter fast speed is assessed at postoperative day 10 and/or discharge.

  2. Short Falls Efficacy Scale-International (Short FES-I)

    Time frame: At discharge

    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.

  3. Verbal Ranking Scale (VRS)

    Time frame: During in-hospital stay.

    Evaluation of experienced hip-fracture related pain at rest and during strength training and testing.

  4. 24-hour activity

    Time frame: From inclusion to discharge

    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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Effect of Rehabilitation With Versus Without Progressive Strength Training Implemented in the Acute Ward After Hip Fracture Surgery: A Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2009
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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