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OpenTrials
Completed

NCT Number: NCT02635308

Enhancing Rehabilitation After Hip Fracture

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unilaterally Biased Resistance Training / "MOVE"

Behavioral

High-intensity resistance training including: whole body movement patterns, unilaterally biased lower extremity strength training, task-oriented balance tasks

Other names: High-Intensity Task Oriented Strength Training / "HI-TOSS"

Primary outcomes

  1. muscle strength

    Time frame: 12 week

    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.

  2. muscle power

    Time frame: 12 week

    Leg extension muscle power was measured on a Nottingham power rig in watts (W). The average of three trials was used.

Secondary outcomes

  1. sit-to-stand task performance

    Time frame: 12 week

    biomechanics (vGRF) measured during sit-to-stand task performance

  2. usual gait speed

    Time frame: 12 week

    Gait speed was measured at usual speed over a 50 foot distance and reported in meters/second.

  3. muscle mass

    Time frame: 12 week

    MRI analysis of quadriceps muscle mass reported as average cross-sectional area in cm2.

  4. Modified Physical Performance Test

    Time frame: 12 week

    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.

  5. Berg Balance Scale

    Time frame: 12 week

    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.

  6. Timed up and Go Test

    Time frame: 12 week

    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.

  7. Stair Climb Test

    Time frame: 12 week

    The time taken to ascend 10 stairs is reported.

  8. Stair Descent Test

    Time frame: 12 week

    The time taken to descend 10 stairs is reported.

  9. Lower Extremity Measure

    Time frame: 12 week

    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.

  10. Activities Specific Balance Scale

    Time frame: 12 week

    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.

  11. Six minute walk test

    Time frame: 12 week.

    The distance in meters (m) walked in six minutes is recorded.

Other outcomes

  1. muscle quality

    Time frame: 12 week

    muscle quality (force/unit area) calculated by using force and mass variables

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Intermountain Health Care, Inc.

Registry information

Official study title

Enhanced Rehabilitation Targeting Strength and Movement Pattern Symmetry Following Hip Fracture

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 18, 2015
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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