Clinical trial NCT02635308: Enhancing Rehabilitation After Hip Fracture
Official title: Enhanced Rehabilitation Targeting Strength and Movement Pattern Symmetry Following Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Keywords: hip fracture
physical function
muscle function
symmetry
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Intermountain Health Care, Inc.
First posted: 2015-12-18
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: muscle strength
timeFrame: 12 week
measure: muscle power
timeFrame: 12 week
Secondary outcomes:
measure: sit-to-stand task performance
timeFrame: 12 week
measure: usual gait speed
timeFrame: 12 week
measure: muscle mass
timeFrame: 12 week
measure: Modified Physical Performance Test
timeFrame: 12 week
measure: Berg Balance Scale
timeFrame: 12 week
measure: Timed up and Go Test
timeFrame: 12 week
measure: Stair Climb Test
timeFrame: 12 week
measure: Stair Descent Test
timeFrame: 12 week
measure: Lower Extremity Measure
timeFrame: 12 week
measure: Activities Specific Balance Scale
timeFrame: 12 week
measure: Six minute walk test
timeFrame: 12 week.
Other outcomes:
measure: muscle quality
timeFrame: 12 week
Locations:
Study officials:
affiliation: University of Utah
name: Robin L Marcus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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