Clinical Trial: Improving Community Ambulation After Hip Fracture

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Improving Community Ambulation After Hip Fracture

Brief Summary:

Hip fracture is a common problem among older individuals. This year in the United States approximately 350,000 people aged 65 and older will break a hip. Despite improvements in therapy, hip fracture can still result in decreases in the strength of bone and muscle, making it difficult to walk and perform daily activities.

Activity and exercise are believed to be of benefit for reducing disability in older adults, yet the majority of older adults do not participate in regular exercise and is not active. This is especially true for older adults following hip fracture after they complete the usual rehabilitation program.

This study is being done to compare two 16-week supervised multi-part physical therapy programs (interventions) initiated up to 26 weeks after hip fracture. The investigators want to test whether the interventions lead to improvements in a person's ability to walk on their own in the home and in the local community. With this knowledge the investigators hope to help a greater number of hip fracture patients enjoy a more complete recovery and improved overall health.


Detailed Summary:

Despite improvements in medical management, significant residual disability remains in older persons after a hip fracture. The goal of current clinical practice is independent, safe household ambulation two to three months after surgery. Hip fracture-acquired dependency in functional activities of daily living persists well beyond three months post-surgery. One year after hip fracture, 20% of patients need help putting on pants, 50% need assistance to walk, and 90% need assistance to climb stairs. This residual disability indicates that current standard Medicare-reimbursed post-hip fracture rehabilitation (i.e., usual care) fails to return many patients to pre-fracture levels of function. In contrast to stroke and heart disease, other commonly occurring acute conditions in the older population, there are few intervention trials focused on decreasing disability following hip fracture. None of the trials for hip fracture has examined the effect of early post-fracture intervention on the ability to ambulate at a level required for independent function in the community (i.e., community ambulation). Thus, there is a paucity of evidence to justify extending medical management beyond usual care in persons following hip fracture to achieve community, rather than merely household, ambulation.

A randomized controlled trial (RCT) including 210 older adults who have experienced a hip fracture will be carried out at three clinical sites with half of the subjects receiving a specific multi-component intervention (PUSH) and the other half receiving a non-specific multi-component intervention (PULSE). Randomization of 210 participants meeting eligibility criteria will take place after post-acute rehabilitation ends, approximately 6 months (26 weeks) after admission to the hospital for hip fracture. The primary endpoint will be measured using the Six-Minute Walk Test (SMWT) at the end of
Sponsor: University of Maryland

Current Primary Outcome: Ability to walk 300 meters or more in six minutes [ Time Frame: 16 weeks post-randomization ]

The primary study outcome reflects the concept of a minimum distance a person needs to be able to walk to carry out usual activities in the community. This will be defined as achieving the threshold value of 300 meters or more on the Six-Minute Walk Test (SMWT). The SMWT is an assessment with excellent psychometric properties, and there is sound justification for a 300 m distance threshold on the SMWT (equivalent to walking at 0.8 m/s) to serve as an indicator for community ambulatory ability.


Original Primary Outcome: Ability to walk 300 meters or more in six minutes [ Time Frame: 16 weeks post-randomization ]

The primary study outcome reflects the concept of a minimum distance a person needs to be able to walk to carry out usual activities in the community. This will be defined as achieving the threshold value of 300 meters or more on the Six-Minute Walk Test (SMWT).[153,154] The SMWT is an assessment with excellent psychometric properties, and there is sound justification for a 300 m distance threshold on the SMWT (equivalent to walking at 0.8 m/s) to serve as an indicator for community ambulatory ability.


Current Secondary Outcome:

  • Endurance [ Time Frame: 16 weeks post-randomization ]
    To assess endurance, the SMWT (described above) will be used to obtain a continuous measure of total distance walked in six minutes. The SMWT is highly correlated with workloads, heart rate, oxygen saturation, and dyspnea responses when compared to bicycle ergometry and treadmill exercise tests in older persons. It has been performed by elderly, frail and severely compromised participants who cannot perform standard maximal treadmill or cycle ergometry exercise tests.
  • Balance [ Time Frame: 16 weeks post-randomization ]
    We will use an enhanced balance measure that includes the balance subscale of the Short Physical Performance Battery (SPPB) and two additional single leg stands (eyes open and eyes closed), as used in the National Health and Aging Trends Study (NHATS). For the test of standing balance, participants are asked to maintain balance in three positions, characterized by a progressive narrowing of the base support (side-by-side, semi-tandem, and tandem). For each of the three positions, participants are timed to a maximum of 10 seconds. Participants are then asked to stand on one leg (on the side of the fracture) with eyes open and again with eyes closed. Each of the single leg stands are held for up to 30 seconds. The number of seconds is then summed across the 5 items to obtain the measure of balance. These tests are hierarchical such that when a participant fails an item, the harder ones are not administered and receive a score of 0.
  • Quadriceps muscle strength [ Time Frame: 16 weeks post-randomization ]

    Isometric force for bilateral knee extensors will be measured with a portable, hand-held dynamometer (Microfet2 Manual Muscle Tester). Participants will be seated on the strength testing chair to increase stabilization, with hip flexion 90° and knee flexed to 70°, stabilization straps on the pelvis and thigh, and resistance applied just proximal to the ankle on the anterior surface of the leg. Participants will be asked to push as hard and as fast as possible for five seconds. Three maximal effort trials, with a one-minute rest between trials, will be performed. The reported test-retest reliability with hand-held dynamometry is excellent (r>.90) if tested in one session and in subjects with muscle weakness (intraclass correlation coefficient ≥ .90). The peak force will be recorded for each of the three trials and the highest value will be used.

    This measure will not be collected for participants consented under protocol version 11.0 or later.

  • Lower extremity function [ Time Frame: 16 weeks post-randomization ]
    A modified version of the Physical Performance Test (mPPT) will be used to measure lower extremity function at baseline and follow-up. The modification, used by Binder et al., substitutes a chair-rise task and a balance task for writing and eating tasks, in order to emphasize lower extremity function. The modified PPT includes nine standardized tasks that will be timed (e.g., picking up a penny from the floor, standing up five times from a 16-inch chair). The tasks are performed twice and the times from the two trials are averaged. The score for each item ranges from 0 to 4, with 36 representing a perfect score. Test-retest reliability for the modified PPT score is 0.96. Because there is some overlap between the mPPT and SPPB items, we have integrated the two scales so that participant burden is minimized but it is still possible to obtain scores on each of the scales.
  • Fast walking speed [ Time Frame: 16 weeks post-randomization ]
    Within the mPPT, participants are asked to walk a distance of 50 feet walking quickly but safely. The time required to walk 50 ft will be the measure of fast walking speed.
  • Cost effectiveness: health care utilization [ Time Frame: Every four weeks, up to 16 weeks post-randomization ]

    The economic value of the interventions will be determined by assessing the impact on quality-adjusted life years (QALYs), cost, and cost per QALY gained over the 16 weeks following randomization. The cost-effectiveness analyses will address both the within trial comparison of the study interventions and a model-based comparison of the study interventions and usual care.

    This measure will not be collected for participants consented under protocol version 11.0 or later.



Original Secondary Outcome:

  • Endurance [ Time Frame: 16 weeks post-randomization ]
    To assess endurance, the SMWT (described above) will be used to obtain a continuous measure of total distance walked in six minutes.[157] The SMWT is highly correlated with workloads, heart rate, oxygen saturation, and dyspnea responses when compared to bicycle ergometry and treadmill exercise tests in older persons.[154,155,157] It has been performed by elderly, frail and severely compromised participants who cannot perform standard maximal treadmill or cycle ergometry exercise tests.[31,158]
  • Balance [ Time Frame: 16 weeks post-randomization ]
    We will use an enhanced balance measure that includes the balance subscale of the Short Physical Performance Battery (SPPB) and two additional single leg stands (eyes open and eyes closed), as used in the National Health and Aging Trends Study (NHATS).[159] For the test of standing balance, participants are asked to maintain balance in three positions, characterized by a progressive narrowing of the base support (side-by-side, semi-tandem, and tandem). For each of the three positions, participants are timed to a maximum of 10 seconds. Participants are then asked to stand on one leg (on the side of the fracture) with eyes open and again with eyes closed. Each of the single leg stands are held for up to 30 seconds. The number of seconds is then summed across the 5 items to obtain the measure of balance. These tests are hierarchical such that when a participant fails an item, the harder ones are not administered and receive a score of 0.
  • Quadriceps muscle strength [ Time Frame: 16 weeks post-randomization ]
    Isometric force for bilateral knee extensors will be measured with a portable, hand-held dynamometer (Microfet2 Manual Muscle Tester). Participants will be seated on the isokinetic dynamometer to increase stabilization, with hip flexion 90° and knee flexed to 70°, stabilization straps on the pelvis and thigh, and resistance applied just proximal to the ankle on the anterior surface of the leg.[160] Participants will be asked to push as hard and as fast as possible for five seconds. Three maximal effort trials, with a one-minute rest between trials, will be performed. The reported test-retest reliability with hand-held dynamometry is excellent (r>.90) if tested in one session and in subjects with muscle weakness (intraclass correlation coefficient ≥ .90).[161-163] The peak force will be recorded for each of the three trials and the highest value will be used.
  • Lower extremity function [ Time Frame: 16 weeks post-randomization ]
    A modified version of the Physical Performance Test (mPPT)[164] will be used to measure lower extremity function at baseline and follow-up. The modification, used by Binder et al., substitutes a chair-rise task and a balance task for writing and eating tasks, in order to emphasize lower extremity function.[68] The modified PPT includes nine standardized tasks that will be timed (e.g., picking up a penny from the floor, standing up five times from a 16-inch chair). The tasks are performed twice and the times from the two trials are averaged. The score for each item ranges from 0 to 4, with 36 representing a perfect score. Test-retest reliability for the modified PPT score is 0.96.[22] Because there is some overlap between the mPPT and SPPB items, we have integrated the two scales so that participant burden is minimized but it is still possible to obtain scores on each of the scales.
  • Fast walking speed [ Time Frame: 16 weeks post-randomization ]
    Within the mPPT, participants are asked to walk a distance of 50 feet walking quickly but safely. The time required to walk 50 ft will be the measure of fast walking speed.
  • Cost effectiveness: health care utilization [ Time Frame: Every four weeks, up to 40 weeks post-randomization ]
    The economic value of the interventions will be determined by assessing the impact on quality-adjusted life years (QALYs), cost, and cost per QALY gained over the 40 weeks following randomization. The cost-effectiveness analyses will address both the within trial comparison of the study interventions and a model-based comparison of the study interventions and usual care.


Information By: University of Maryland

Dates:
Date Received: January 31, 2013
Date Started: June 2013
Date Completion: April 2018
Last Updated: May 1, 2017
Last Verified: April 2017