Observation and Progressive Strength Training After Hip Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01129219
Recruitment Status : Unknown
Verified March 2007 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 24, 2010
Last Update Posted : May 24, 2010
Diakonhjemmet Hospital
Information provided by:
Oslo University Hospital

Brief Summary:
This is a randomized, controlled; single-blind parallel group trial carried out with hip fracture patients, starting at 12 weeks post fracture. Patients were approached during their acute stay in hospital, followed without any extra intervention for 12 weeks, and then randomized in a 2:1 manner to either intervention or control for the next 12 weeks. After the first 12 weeks intervention the intervention group were divided into two groups and randomized to an new single-blind parallel group trial for further intervention.

Condition or disease Intervention/treatment
Exercise Other: Strength training

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Observation and Progressive Strength Training After Hip Fracture
Study Start Date : June 2007
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : December 2010

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Usual care
Subjects in the control group were asked to maintain their current lifestyle. No restrictions were placed on their exercise activities.
Other: Strength training
Strength training for 24 weeks

Primary Outcome Measures :
  1. Bergs Balance scale [ Time Frame: 24 weeks ]
    Bergs Balance Scale: The Berg balance scale (BBS) measures "functional balance," which has three dimensions: maintenance of a position, postural adjustment to voluntary movements, and reaction to external disturbance, scored 0-56 (Berg K. 1995).

Secondary Outcome Measures :
  1. Strength [ Time Frame: 24 weeks ]
    Secondary outcomes was the results on the Sit to Stand-test,which measure strength of lower limbs.

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:at 12 weeks postoperative:

  1. age at least 65 years
  2. not living in nursing home
  3. were able to undergo physical therapy for the hip fracture
  4. scoring of 23 or more (out of 30) on the Mini Mental State Examination

Exclusion Criteria:

  1. permanently institutionalized
  2. had metastatic cancer
  3. suffered from multi-trauma.

Publications of Results:
Helen H Host, David R Sinacore, Kathryn L Bohnert, Karen Steger-May, Marybeth Brown and Ellen F Binder. Training-Induced Strength and Functional Adaptations After Hip Fracture. PHYS THER Vol. 87, No. 3, March 2007, pp. 292-303 Ellen F. Binder, MD; Marybeth Brown, PT, PhD; David R. Sinacore, PT, PhD; Karen Steger-May, MA; Kevin E. Yarasheski, PhD; Kenneth B. Schechtman. Effects of Extended Outpatient Rehabilitation After Hip Fracture. A Randomized Controlled Trial JAMA. 2004;292:837-846. Kathleen K Mangione, Rebecca L Craik, Susan S Tomlinson and Kerstin M Palombaro. Can Elderly Patients Who Have Had a Hip Fracture Perform Moderate- to High-Intensity Exercise at Home? PHYS THER Vol. 85, No. 8, August 2005, pp. 727-739 Klaus Hauer, Norbert Specht, Matthias Schuler, Peter Bärtsch1 and Peter Oster. Intensive physical training in geriatric patients after severe falls and hip surgery. Age and Ageing 2002; 31: 49-57 2002. David Moher1 , Kenneth F Schulz2 and Douglas G Altman. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Medical Research Methodology 2001, 1:2doi:10.1186/1471-2288-1-2 Berg K, Wood-Dauphinee S, Williams JI. The Balance Scale: reliability assessment with elderly residents and patients with an acute stroke. Scand J Rehabil Med. 1995 Mar;27(1):27-36. Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. Podsiadlo D, Richardson S. The timed

Responsible Party: Mette Martinsen, Diakonhjemmet Sykehus Identifier: NCT01129219     History of Changes
Other Study ID Numbers: 1.2007.347
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: May 24, 2010
Last Verified: March 2007

Keywords provided by Oslo University Hospital:

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