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

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ClinicalTrials.gov Identifier: NCT01872637
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
Arcadia University
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Frail Older Adults Behavioral: Progressive Multi-Component Intervention Behavioral: Usual Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving Activity, Participation And Function After Acute Hospitalization In Older Adults With Multiple Chronic Conditions: Phase II Randomized Controlled Trial
Study Start Date : June 2011
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Progressive Multi-Component Intervention
Patients in this exercise group will receive 10-18, 45-60 minute, physical therapy visits in their home. This group will consist of progressive resistance exercises for the upper and lower extremity with a portable training device, a motor control-based program of gait/balance training, Activities of Daily Living (ADL) training, and mobility training.
Behavioral: Progressive Multi-Component Intervention
Active Comparator: Usual Care Group
The patients in this group will receive approximately five visits of "usual home care" but the total number of visits will be determined by the therapist as part of usual care. These visits will likely occur at 1-2 times per week for 3-4 weeks. This group will receive intervention as determined by the physical therapist's initial examination. Interventions may include patient education, home exercises, low intensity strengthening exercise, training in gait, balance and transfers; home safety and assistive device assessment.
Behavioral: Usual Care



Primary Outcome Measures :
  1. Gait Speed [ Time Frame: 60 days ]
    Time it takes to walk a 4 meter path, key to independent functioning


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • dialysis
  • hospice care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872637


Locations
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United States, Colorado
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, United States, 80045
United States, Pennsylvania
Arcadia University
Glenside, Pennsylvania, United States, 19038
Sponsors and Collaborators
University of Colorado, Denver
Arcadia University
Investigators
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Principal Investigator: Jennifer E Stevens-Lapsley, PT, PhD University of Colorado, Denver
Principal Investigator: Kate Mangione, PT, PhD Arcadia University

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01872637     History of Changes
Other Study ID Numbers: 10-0432
Innovator's Fund ( Other Grant/Funding Number: Abington Memorial Innovator's Fund )
APTA ( Other Grant/Funding Number: APTA Home Health Section )
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Multiple Chronic Conditions
Chronic Disease
Disease Attributes
Pathologic Processes