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Observation and Progressive Strength Training After Hip Fracture

Primary Purpose

Exercise

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Strength training
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise focused on measuring Strength, Function, Mobility

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Usual care

    Arm Description

    Subjects in the control group were asked to maintain their current lifestyle. No restrictions were placed on their exercise activities.

    Outcomes

    Primary Outcome Measures

    Bergs Balance scale
    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
    Secondary outcomes was the results on the Sit to Stand-test,which measure strength of lower limbs.

    Full Information

    First Posted
    May 18, 2010
    Last Updated
    May 21, 2010
    Sponsor
    Oslo University Hospital
    Collaborators
    Diakonhjemmet Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01129219
    Brief Title
    Observation and Progressive Strength Training After Hip Fracture
    Official Title
    Observation and Progressive Strength Training After Hip Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2007
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2007 (undefined)
    Primary Completion Date
    June 2010 (Anticipated)
    Study Completion Date
    December 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Oslo University Hospital
    Collaborators
    Diakonhjemmet Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exercise
    Keywords
    Strength, Function, Mobility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual care
    Arm Type
    Experimental
    Arm Description
    Subjects in the control group were asked to maintain their current lifestyle. No restrictions were placed on their exercise activities.
    Intervention Type
    Other
    Intervention Name(s)
    Strength training
    Intervention Description
    Strength training for 24 weeks
    Primary Outcome Measure Information:
    Title
    Bergs Balance scale
    Description
    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).
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Strength
    Description
    Secondary outcomes was the results on the Sit to Stand-test,which measure strength of lower limbs.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria:at 12 weeks postoperative: age at least 65 years not living in nursing home were able to undergo physical therapy for the hip fracture scoring of 23 or more (out of 30) on the Mini Mental State Examination Exclusion Criteria: permanently institutionalized had metastatic cancer suffered from multi-trauma.

    12. IPD Sharing Statement

    Citations:
    Citation
    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
    Results Reference
    result
    PubMed Identifier
    36070134
    Citation
    Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
    Results Reference
    derived

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    Observation and Progressive Strength Training After Hip Fracture

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