Training of Patients With Hip Fracture

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Lolland Community, Denmark
Sponsor:
Collaborators:
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: April 29, 2014
Last verified: April 2014
  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: July 2014 (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
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: 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
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

Additional 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: April 29, 2014
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 July 22, 2014