Observation and Progressive Strength Training After Hip Fracture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Diakonhjemmet Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01129219
First received: May 18, 2010
Last updated: May 21, 2010
Last verified: March 2007
  Purpose

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 Intervention
Exercise
Other: Strength training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Observation and Progressive Strength Training After Hip Fracture

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Bergs Balance scale [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Strength [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Secondary outcomes was the results on the Sit to Stand-test,which measure strength of lower limbs.


Enrollment: 150
Study Start Date: June 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Mette Martinsen, Diakonhjemmet Sykehus
ClinicalTrials.gov Identifier: NCT01129219     History of Changes
Other Study ID Numbers: 1.2007.347
Study First Received: May 18, 2010
Last Updated: May 21, 2010
Health Authority: Norway: Ethics Committee

Keywords provided by Oslo University Hospital:
Strength
Function
Mobility

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

ClinicalTrials.gov processed this record on April 15, 2014