Strength Training After Hip Fracture Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hvidovre University Hospital
Sponsor:
Information provided by (Responsible Party):
Morten Tange Kristensen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00848913
First received: February 19, 2009
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Hip Fracture
Other: Rehabilitation with strength training
Other: Rehabilitation without strength training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Rehabilitation With Versus Without Progressive Strength Training Implemented in the Acute Ward After Hip Fracture Surgery: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: From inclusion to postoperative day 10 and/or discharge ] [ Designated as safety issue: No ]
    Timed Up and Go test is assessed as early as possible during in-hospital stay and at discharge.


Other Outcome Measures:
  • 10 meter fast speed, Cumulated Ambulation Score. [ Time Frame: At discharge and during in-hospital stay. ] [ Designated as safety issue: No ]
    Cumulated Ambulation Score is recorded every day from inclusion to discharge. 10 meter fast speed is assessed at postoperative day 10 and/or discharge.

  • Short Falls Efficacy Scale-International (Short FES-I) [ Time Frame: At discharge ] [ Designated as safety issue: No ]
    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.

  • Verbal Ranking Scale (VRS) [ Time Frame: During in-hospital stay. ] [ Designated as safety issue: No ]
    Evaluation of experienced hip-fracture related pain at rest and during strength training and testing.

  • 24-hour activity [ Time Frame: From inclusion to discharge ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: October 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rehabilitation without strength training
Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.
Other: Rehabilitation without strength training
Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.
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.
Other: 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 the fractured limb using ankle weight cuffs, daily during hospital stay.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848913

Contacts
Contact: Morten T Kristensen, PhD 0045 38626191 morten.tange.kristensen@hh.regionh.dk
Contact: Thomas Bandholm, PhD 004538626344 thomas.bandholm@hh.regionh.dk

Locations
Denmark
Department of Orthopedic Surgery hvidovre hospital Recruiting
Hvidovre, Copenhagen, Denmark, 2650
Contact: Morten T Kristensen, PhD    0045 38626191    morten.tange.kristensen@hh.regionh.dk   
Principal Investigator: Lise Kronborg, Msc, PhDstud         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Lise Kronborg, MSc PMR-C, Copenhagen University at Hvidovre Hospital.
  More Information

No publications provided

Responsible Party: Morten Tange Kristensen, Seniorresearcher, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00848913     History of Changes
Other Study ID Numbers: H-A-2007-0127 + 37036
Study First Received: February 19, 2009
Last Updated: August 21, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Hvidovre University Hospital:
strength deficit
physical function

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 18, 2014