Training of Patients With Hip Fracture

This study is currently recruiting participants.
Verified November 2013 by Lolland Community, Denmark
Sponsor:
Collaborators:
Denmark: Association of Danish Physiotherapists
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
Mr. Jan Overgaard, Lolland Community, Denmark
ClinicalTrials.gov Identifier:
NCT01174589
First received: July 21, 2010
Last updated: November 17, 2013
Last verified: November 2013
  Purpose

The primary purpose of this study is to illustrate whether there is a difference in the 6 minutes walking test in patients with hip fractures who have received 6 vs. 12 weeks of physical training after discharge from hospital.


Condition Intervention Phase
Hip Fracture
Other: Strength training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strength Training of Patients With Hip Fracture - a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Lolland Community, Denmark:

Primary Outcome Measures:
  • Difference in the 6-minutes walking test [ Time Frame: at baseline, 6 weeks, 12 weeks (primary analysis) and 24 weeks after baseline testing ] [ Designated as safety issue: No ]
    The 6-minutes walking test, performed according to international guidelines.


Secondary Outcome Measures:
  • Difference of the Maximal isometric knee-extension strength of the fractured limb. [ Time Frame: Baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing ] [ Designated as safety issue: No ]
    The best of 5 maximal isometric unilateral knee-extension strength tests of both limbs, measured with a fixated handheld dynamometer

  • Difference in 10-meter fast speed walking test [ Time Frame: At baseline, 6 weeks, 12 weeks, and 24 weeks after baseline testing ] [ Designated as safety issue: No ]
    Best of 3 timed 10 meter fast speed walk tests.

  • Difference in the Timed Up & Go test [ Time Frame: At baseline and 6 weeks, 12 weeks and 24 weeks after baseline testing ] [ Designated as safety issue: No ]
    Best of 3 timed TUG tests will be used.

  • Difference in the Short Form-36 [ Time Frame: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing ] [ Designated as safety issue: No ]
    The Questionnaire will be filled out during an interview with the patient

  • Difference in the New Mobility Score [ Time Frame: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing ] [ Designated as safety issue: No ]
    The questionnaire will be filled out during an interview with the patient.


Other Outcome Measures:
  • Difference in the Barthel 0-20 points ADL-score [ Time Frame: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing ] [ Designated as safety issue: No ]
    The questionnaire will be filled out during an interview with the patient

  • The Tandem Balance test 0-30 points [ Time Frame: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
6 weeks of physical training
The 6 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week.
Other: Strength training
to compare if there is a difference between 6 or 12 weeks of physical strength training
12 weeks of physical exercise
The 12 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week.
Other: Strength training
to compare if there is a difference between 6 or 12 weeks of physical strength training

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with hip fractures
  • full weightbearing on the affected leg
  • patients living in their own home with an independent walking ability score >=2 according to the New Mobility Score scale
  • written consent

Exclusion Criteria:

  • institutionalized patients
  • more than 2 weeks after discharge from hospital
  • non weight bearing on the affected leg
  • Dementia
  • other conditions/diagnosis that would have an effect on the ability to train eg. neurological diagnosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174589

Locations
Denmark
Maribo Health Center Recruiting
Maribo, Denmark, 4930
Contact: Jan Overgaard, Bachelor    +4554676942    jover@lolland.dk   
Contact: Pernille Pasquali, Master    +4554676945    pepa@lolland.dk   
Principal Investigator: Jan Overgaard, Bachelor         
Sponsors and Collaborators
Lolland Community, Denmark
Denmark: Association of Danish Physiotherapists
Copenhagen University Hospital, Hvidovre
Investigators
Principal Investigator: Jan Overgaard, Bachelor Sector of health, rehabilitation, Lolland community, Denmark
Study Director: Morten T Kristensen, PhD Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark
  More Information

No publications provided

Responsible Party: Mr. Jan Overgaard, Physiotherapist, Bachelor, Sector of Health, Rehabilitation, Lolland Community., Lolland Community, Denmark
ClinicalTrials.gov Identifier: NCT01174589     History of Changes
Other Study ID Numbers: SJ-145
Study First Received: July 21, 2010
Last Updated: November 17, 2013
Health Authority: Denmark: National Board of Health
Denmark: Danish Dataprotection Agency

Keywords provided by Lolland Community, Denmark:
Lower limb strength training
Randomized clinical trial
Patients with Hip fracture
6 vs. 12 weeks physical strength training

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

ClinicalTrials.gov processed this record on April 14, 2014