Enhancing Rehabilitation After Hip Fracture

December 15, 2015 updated by: Robin Marcus, University of Utah

Enhanced Rehabilitation Targeting Strength and Movement Pattern Symmetry Following 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
High-Intensity, Unilaterally-Biased Resistance training 3x/wk x 12wk "MOVE"
Behavioral: Unilaterally Biased Resistance Training / "MOVE"
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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 week
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.
12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sit-to-stand task performance
Time Frame: 12 week
biomechanics (vGRF) measured during sit-to-stand task performance
12 week
usual gait speed
Time Frame: 12 week
Gait speed was measured at usual speed over a 50 foot distance and reported in meters/second.
12 week
muscle mass
Time Frame: 12 week
MRI analysis of quadriceps muscle mass reported as average cross-sectional area in cm2.
12 week
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.
12 week
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.
12 week
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.
12 week
Stair Climb Test
Time Frame: 12 week
The time taken to ascend 10 stairs is reported.
12 week
Stair Descent Test
Time Frame: 12 week
The time taken to descend 10 stairs is reported.
12 week
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.
12 week
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.
12 week
Six minute walk test
Time Frame: 12 week.
The distance in meters (m) walked in six minutes is recorded.
12 week.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle quality
Time Frame: 12 week
muscle quality (force/unit area) calculated by using force and mass variables
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Intermountain Health Care, Inc.

Investigators

  • Principal Investigator: Robin L Marcus, PhD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 15, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00062639

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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