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Completed

NCT Number: NCT01872637

Improving Function, Participation and Function After Acute Hospitalization in Older Adults

Hospitalization increases the risk for new disability in older adults. In the current health care system, home health physical therapy is understudied and often does not return older adults to prior levels of function. The proposed evidence-based multicomponent intervention that combines high intensity strength training and motor control based systems of gait and balance training will advance clinical practice by providing an intervention strategy for practitioners. If successful, improving patient function and decreasing re-hospitalization rates and falls will have large cost saving implications.

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Key information

Conditions

Frail Older Adults

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado, United States

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About this study

Background: Hospitalized older adults are 59.8 times more likely to develop disability than those who are not hospitalized. No studies have examined the effectiveness of Home Health (HH) physical therapy on improving function in older adults with multiple co-morbidities after hospitalization. Our goal is to enable older adults with multiple chronic conditions to recover function by providing adequate content and dose of intervention after hospitalization. This intervention is designed to work within the existing Medicare system and has potential for immediate clinical impact.

Purpose: The primary aim of our study is to determine if a progressive multi-component (PMC) intervention, initiated upon discharge from an acute care hospital, improves gait speed at the end of one 60-day episode of care, more than documented usual care (UC) physical therapy. We hypothesize that there will be a greater improvement in gait speed measured for the PMC group compared to the UC group following one episode of care. Benefits of PMC will be apparent at the end of usual care and will increase further at the end of the 60 day episode of care (primary endpoint).

Design: We propose to conduct a single blind randomized two arm clinical trial (RCT) in older adults discharged from acute care and referred to HH physical therapy. Both interventions (PMC & UC) will be Medicare-reimbursed. All assessments and interventions will occur in the patients' homes.

Methods: Twenty individuals who are 65 years of age or older with multiple co-morbid conditions will be enrolled.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 65 years or older
  • referred to home care physical therapy
  • have at least 3 comorbid conditions
  • ambulatory without human assistance prior to hospitalization

Exclusion criteria

  • acute lower extremity fractures with weight-bearing restriction
  • elective joint replacement surgery
  • active cancer diagnosis
  • acute cardiac surgery
  • lower extremity amputation
  • referred to hospice home health physical therapy
  • dialysis
  • hospice care

Treatment and study plan

Progressive Multi-Component Intervention

Behavioral

Usual Care

Behavioral

Primary outcomes

  1. Gait Speed

    Time frame: 60 days

    Time it takes to walk a 4 meter path, key to independent functioning

Secondary outcomes

  1. Modified Physical Performance Test (mPPT)

    Time frame: 60 days

    Assesses 7 different tasks. Based on the time taken to complete the tasks, a score from 0 (unable to complete) to 4 (performed quickly and easily) if given for each task. A maximal score of 28 is given, including tasks that involved the upper and lower extremity function.

  2. Late-Life Function and Disability Instrument (LLFDI)

    Time frame: 60 days

    Evaluates limitation and frequency of taking part in 16 major life tasks in its disability component, and 32 functional tasks in its functional component, of which 14 tasks comprise basic lower extremity function.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Arcadia University

Registry information

Official study title

Improving Activity, Participation And Function After Acute Hospitalization In Older Adults With Multiple Chronic Conditions: Phase II Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 7, 2013
Registry last updated
May 17, 2017

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

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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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