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Enhancing Rehabilitation After Hip Fracture

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Unilaterally Biased Resistance Training / "MOVE"
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring hip fracture, physical function, muscle function, symmetry

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age greater than 50 yrs
  • Ability to sign informed consent
  • Mental Status MoCA score greater than 22
  • Independent community ambulatory prior to hip fracture
  • Ability to ambulate greater than 50 feet with or without assistive device

Exclusion Criteria:

  • Previous hip fracture
  • Bilateral hip fracture
  • Pathological fracture
  • Expected life Expectancy less than one year
  • Permanently institutionalized
  • Fracture result of multi-trauma
  • Cardiac abnormalities
  • Neuromuscular impairments
  • Unstable medical conditions
  • Elevated systolic greater than 150 or diastolic blood pressure greater than 100
  • Implanted electronic devices
  • History of stroke with motor disability
  • Alcohol or drug abuse
  • Respiratory disease
  • Conditions deemed exclusionary by PI or physician

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental

    Arm Description

    High-Intensity, Unilaterally-Biased Resistance training 3x/wk x 12wk "MOVE"

    Outcomes

    Primary Outcome Measures

    muscle strength
    Knee extension muscle strength was measured on an isokinetic dynamometer as a maximum voluntary isometric contraction in newtons (N) of force. The average of three trials was used.
    muscle power
    Leg extension muscle power was measured on a Nottingham power rig in watts (W). The average of three trials was used.

    Secondary Outcome Measures

    sit-to-stand task performance
    biomechanics (vGRF) measured during sit-to-stand task performance
    usual gait speed
    Gait speed was measured at usual speed over a 50 foot distance and reported in meters/second.
    muscle mass
    MRI analysis of quadriceps muscle mass reported as average cross-sectional area in cm2.
    Modified Physical Performance Test
    The modified physical performance test (mPPT) is a standardized nine-item test designed to assess multiple dimensions of physical function was used to assess overall physical function. Scores are reported on a scale from 0-36.
    Berg Balance Scale
    The Berg Balance Scale (BBS) is a 14-item objective scale that provides a reliable and valid measure of static balance, with scores less than 45 indicating significant fall risk among older adults. Scores range from 0-56.
    Timed up and Go Test
    The Timed up and go test is recorded as the time in seconds to stand, walk 3 meters, turn around and return to a chair. The average time of three trials is reported.
    Stair Climb Test
    The time taken to ascend 10 stairs is reported.
    Stair Descent Test
    The time taken to descend 10 stairs is reported.
    Lower Extremity Measure
    The Lower Extremity Measure (LEM) is a 29-item self-report questionnaire that is reliable, valid, and responsive to improvement, with scores of 75 indicating moderate frailty, and scores above 85 indicating normal mobility and physical function after hip fracture. Scores range from 0-100.
    Activities Specific Balance Scale
    Activities-Specific Balance Confidence (ABC) scale is a 16-item, validated, reliable, self-report scale used to determine balance confidence. Scores range from 0-100.
    Six minute walk test
    The distance in meters (m) walked in six minutes is recorded.

    Full Information

    First Posted
    November 30, 2015
    Last Updated
    December 15, 2015
    Sponsor
    University of Utah
    Collaborators
    Intermountain Health Care, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02635308
    Brief Title
    Enhancing Rehabilitation After Hip Fracture
    Official Title
    Enhanced Rehabilitation Targeting Strength and Movement Pattern Symmetry Following Hip Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Utah
    Collaborators
    Intermountain Health Care, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the feasibility of implementing a unilaterally biased high-intensity resistance training to facilitate restorative vs. compensatory recovery after "usual care" physical therapy among older adults who have recently incurred a hip fracture. Additionally, physical performance during a sit-to-stand task, muscle function (strength/power), physical function measures, muscle composition, and muscle quality (force/unit area), are assessed before and after targeted high-intensity resistance training.
    Detailed Description
    Hip fracture is a major public health concern in the United States. Fall-related injuries constitute the leading cause of deaths and disabilities among persons over age 65 years. Hip fracture is consistently identified as one of the most frequent, costly, and devastating non-lethal injuries from a fall. Rehabilitation after hip fracture remains largely unchanged over the last 30 years despite evidence that high-intensity rehabilitation can benefit physical function after hip fracture beyond the recovery typical with "usual care". Asymmetries demonstrated in physical performance of various tasks, such as gait, balance, and a sit-to-stand transfer, and impaired surgical limb muscle function are evident for years after hip fracture, and may contribute to the high rate of falls and declining function typically encountered by older adults recovering from hip fracture. Implementing a high-intensity rehabilitation approach targeting asymmetries after hip fracture is likely to yield improved symmetry in both physical function and muscle function. This study will recruit older adults who have recently incurred a hip fracture and completed "usual care" physical therapy to determine whether a high-intensity rehabilitation strategy targeting asymmetries in movement strategies and muscle function of the surgical limb can be successfully implemented in this challenging population. In particular, recruitment, adherence to rehab protocol parameters, and retention will be addressed among those who initiate high-resistance training at approximately 8-12wk after hip fracture incidence. In addition, the investigators will explore the potential of targeted unilaterally-biased resistance training to improve surgical limb function and performance after hip fracture. Specifically, physical performance, muscle function, and muscle quality/composition are recorded and compared pre-/post-training to determine whether improvements occur in conjunction with high-intensity rehabilitation training. Additionally, the investigators will measure improvements in muscle composition that occur as a result of this high-intensity resistance training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Fracture
    Keywords
    hip fracture, physical function, muscle function, symmetry

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    High-Intensity, Unilaterally-Biased Resistance training 3x/wk x 12wk "MOVE"
    Intervention Type
    Behavioral
    Intervention Name(s)
    Unilaterally Biased Resistance Training / "MOVE"
    Other Intervention Name(s)
    High-Intensity Task Oriented Strength Training / "HI-TOSS"
    Intervention Description
    High-intensity resistance training including: whole body movement patterns, unilaterally biased lower extremity strength training, task-oriented balance tasks
    Primary Outcome Measure Information:
    Title
    muscle strength
    Description
    Knee extension muscle strength was measured on an isokinetic dynamometer as a maximum voluntary isometric contraction in newtons (N) of force. The average of three trials was used.
    Time Frame
    12 week
    Title
    muscle power
    Description
    Leg extension muscle power was measured on a Nottingham power rig in watts (W). The average of three trials was used.
    Time Frame
    12 week
    Secondary Outcome Measure Information:
    Title
    sit-to-stand task performance
    Description
    biomechanics (vGRF) measured during sit-to-stand task performance
    Time Frame
    12 week
    Title
    usual gait speed
    Description
    Gait speed was measured at usual speed over a 50 foot distance and reported in meters/second.
    Time Frame
    12 week
    Title
    muscle mass
    Description
    MRI analysis of quadriceps muscle mass reported as average cross-sectional area in cm2.
    Time Frame
    12 week
    Title
    Modified Physical Performance Test
    Description
    The modified physical performance test (mPPT) is a standardized nine-item test designed to assess multiple dimensions of physical function was used to assess overall physical function. Scores are reported on a scale from 0-36.
    Time Frame
    12 week
    Title
    Berg Balance Scale
    Description
    The Berg Balance Scale (BBS) is a 14-item objective scale that provides a reliable and valid measure of static balance, with scores less than 45 indicating significant fall risk among older adults. Scores range from 0-56.
    Time Frame
    12 week
    Title
    Timed up and Go Test
    Description
    The Timed up and go test is recorded as the time in seconds to stand, walk 3 meters, turn around and return to a chair. The average time of three trials is reported.
    Time Frame
    12 week
    Title
    Stair Climb Test
    Description
    The time taken to ascend 10 stairs is reported.
    Time Frame
    12 week
    Title
    Stair Descent Test
    Description
    The time taken to descend 10 stairs is reported.
    Time Frame
    12 week
    Title
    Lower Extremity Measure
    Description
    The Lower Extremity Measure (LEM) is a 29-item self-report questionnaire that is reliable, valid, and responsive to improvement, with scores of 75 indicating moderate frailty, and scores above 85 indicating normal mobility and physical function after hip fracture. Scores range from 0-100.
    Time Frame
    12 week
    Title
    Activities Specific Balance Scale
    Description
    Activities-Specific Balance Confidence (ABC) scale is a 16-item, validated, reliable, self-report scale used to determine balance confidence. Scores range from 0-100.
    Time Frame
    12 week
    Title
    Six minute walk test
    Description
    The distance in meters (m) walked in six minutes is recorded.
    Time Frame
    12 week.
    Other Pre-specified Outcome Measures:
    Title
    muscle quality
    Description
    muscle quality (force/unit area) calculated by using force and mass variables
    Time Frame
    12 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age greater than 50 yrs Ability to sign informed consent Mental Status MoCA score greater than 22 Independent community ambulatory prior to hip fracture Ability to ambulate greater than 50 feet with or without assistive device Exclusion Criteria: Previous hip fracture Bilateral hip fracture Pathological fracture Expected life Expectancy less than one year Permanently institutionalized Fracture result of multi-trauma Cardiac abnormalities Neuromuscular impairments Unstable medical conditions Elevated systolic greater than 150 or diastolic blood pressure greater than 100 Implanted electronic devices History of stroke with motor disability Alcohol or drug abuse Respiratory disease Conditions deemed exclusionary by PI or physician
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robin L Marcus, PhD
    Organizational Affiliation
    University of Utah
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22565360
    Citation
    Kneiss JA, Houck JR, Bukata SV, Puzas JE. Influence of upper extremity assistance on lower extremity force application symmetry in individuals post-hip fracture during the sit-to-stand task. J Orthop Sports Phys Ther. 2012 May;42(5):474-81. doi: 10.2519/jospt.2012.3562. Epub 2012 Apr 30.
    Results Reference
    background
    PubMed Identifier
    25497603
    Citation
    Kneiss JA, Hilton TN, Tome J, Houck JR. Weight-bearing asymmetry in individuals post-hip fracture during the sit to stand task. Clin Biomech (Bristol, Avon). 2015 Jan;30(1):14-21. doi: 10.1016/j.clinbiomech.2014.11.012. Epub 2014 Nov 29.
    Results Reference
    background
    PubMed Identifier
    22842835
    Citation
    Edgren J, Rantanen T, Heinonen A, Portegijs E, Alen M, Kiviranta I, Kallinen M, Sipila S. Effects of progressive resistance training on physical disability among older community-dwelling people with history of hip fracture. Aging Clin Exp Res. 2012 Apr;24(2):171-5. doi: 10.1007/BF03325162.
    Results Reference
    background
    PubMed Identifier
    18760151
    Citation
    Portegijs E, Kallinen M, Rantanen T, Heinonen A, Sihvonen S, Alen M, Kiviranta I, Sipila S. Effects of resistance training on lower-extremity impairments in older people with hip fracture. Arch Phys Med Rehabil. 2008 Sep;89(9):1667-74. doi: 10.1016/j.apmr.2008.01.026.
    Results Reference
    background
    PubMed Identifier
    18303470
    Citation
    Portegijs E, Sipila S, Rantanen T, Lamb SE. Leg extension power deficit and mobility limitation in women recovering from hip fracture. Am J Phys Med Rehabil. 2008 May;87(5):363-70. doi: 10.1097/PHM.0b013e318164a9e2.
    Results Reference
    background
    PubMed Identifier
    22884315
    Citation
    Edgren J, Salpakoski A, Rantanen T, Heinonen A, Kallinen M, von Bonsdorff MB, Portegijs E, Sihvonen S, Sipila S. Balance confidence and functional balance are associated with physical disability after hip fracture. Gait Posture. 2013 Feb;37(2):201-5. doi: 10.1016/j.gaitpost.2012.07.001. Epub 2012 Aug 9.
    Results Reference
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    PubMed Identifier
    17284548
    Citation
    Host HH, Sinacore DR, Bohnert KL, Steger-May K, Brown M, Binder EF. Training-induced strength and functional adaptations after hip fracture. Phys Ther. 2007 Mar;87(3):292-303. doi: 10.2522/ptj.20050396. Epub 2007 Feb 6.
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    PubMed Identifier
    15315998
    Citation
    Binder EF, Brown M, Sinacore DR, Steger-May K, Yarasheski KE, Schechtman KB. Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):837-46. doi: 10.1001/jama.292.7.837.
    Results Reference
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    PubMed Identifier
    21196069
    Citation
    Houck J, Kneiss J, Bukata SV, Puzas JE. Analysis of vertical ground reaction force variables during a Sit to Stand task in participants recovering from a hip fracture. Clin Biomech (Bristol, Avon). 2011 Jun;26(5):470-6. doi: 10.1016/j.clinbiomech.2010.12.004. Epub 2010 Dec 31.
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    PubMed Identifier
    25958401
    Citation
    Miller RR, Eastlack M, Hicks GE, Alley DE, Shardell MD, Orwig DL, Goodpaster BH, Chomentowski PJ, Hawkes WG, Hochberg MC, Ferrucci L, Magaziner J. Asymmetry in CT Scan Measures of Thigh Muscle 2 Months After Hip Fracture: The Baltimore Hip Studies. J Gerontol A Biol Sci Med Sci. 2015 Jun;70(6):753-6. doi: 10.1093/gerona/glr188.
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    PubMed Identifier
    24370941
    Citation
    D'Adamo CR, Hawkes WG, Miller RR, Jones M, Hochberg M, Yu-Yahiro J, Hebel JR, Magaziner J. Short-term changes in body composition after surgical repair of hip fracture. Age Ageing. 2014 Mar;43(2):275-80. doi: 10.1093/ageing/aft198. Epub 2013 Dec 25.
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    PubMed Identifier
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    Citation
    Penrod JD, Boockvar KS, Litke A, Magaziner J, Hannan EL, Halm EA, Silberzweig SB, Sean Morrison R, Orosz GM, Koval KJ, Siu AL. Physical therapy and mobility 2 and 6 months after hip fracture. J Am Geriatr Soc. 2004 Jul;52(7):1114-20. doi: 10.1111/j.1532-5415.2004.52309.x.
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    Enhancing Rehabilitation After Hip Fracture

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