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
About this trial
This is an interventional treatment trial for Hip Fracture focused on measuring hip fracture, physical function, muscle function, symmetry
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
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
NCT ID
NCT02635308
First Posted
November 30, 2015
Last Updated
December 15, 2015
Sponsor
University of Utah
Collaborators
Intermountain Health Care, Inc.
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
background
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.
Results Reference
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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
background
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.
Results Reference
background
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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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.
Results Reference
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PubMed Identifier
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Citation
Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, Felsenthal G, Kenzora J. Recovery from hip fracture in eight areas of function. J Gerontol A Biol Sci Med Sci. 2000 Sep;55(9):M498-507. doi: 10.1093/gerona/55.9.m498.
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PubMed Identifier
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Citation
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Results Reference
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Enhancing Rehabilitation After Hip Fracture
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