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Clinical Trials/NCT01872637
NCT01872637
Completed
Not Applicable

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

University of Colorado, Denver2 sites in 1 country30 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frail Older Adults
Sponsor
University of Colorado, Denver
Enrollment
30
Locations
2
Primary Endpoint
Gait Speed
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
May 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • hospice care

Outcomes

Primary Outcomes

Gait Speed

Time Frame: 60 days

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

Secondary Outcomes

  • Modified Physical Performance Test (mPPT)(60 days)
  • Late-Life Function and Disability Instrument (LLFDI)(60 days)

Study Sites (2)

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