Improving Function, Participation and Function After Acute Hospitalization in Older Adults
|ClinicalTrials.gov Identifier: NCT01872637|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Frail Older Adults||Behavioral: Progressive Multi-Component Intervention Behavioral: Usual Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- Gait Speed [ Time Frame: 60 days ]Time it takes to walk a 4 meter path, key to independent functioning
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872637
|United States, Colorado|
|University of Colorado Denver, Anschutz Medical Campus|
|Aurora, Colorado, United States, 80045|
|United States, Pennsylvania|
|Glenside, Pennsylvania, United States, 19038|
|Principal Investigator:||Jennifer E Stevens-Lapsley, PT, PhD||University of Colorado, Denver|
|Principal Investigator:||Kate Mangione, PT, PhD||Arcadia University|