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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01872637
Other study ID # 10-0432
Secondary ID Innovator's Fund
Status Completed
Phase N/A
First received June 4, 2013
Last updated May 15, 2017
Start date June 2011
Est. completion date May 2017

Study information

Verified date May 2017
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Progressive Multi-Component Intervention

Usual Care


Locations

Country Name City State
United States University of Colorado Denver, Anschutz Medical Campus Aurora Colorado
United States Arcadia University Glenside Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver Arcadia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gait Speed Time it takes to walk a 4 meter path, key to independent functioning 60 days
Secondary Modified Physical Performance Test (mPPT) 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. 60 days
Secondary Late-Life Function and Disability Instrument (LLFDI) 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. 60 days
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