This trial is active, not recruiting.

Condition frail older adults
Treatments progressive multi-component intervention, usual care
Sponsor University of Colorado, Denver
Collaborator Arcadia University
Start date June 2011
End date March 2019
Trial size 30 participants
Trial identifier NCT01872637, 10-0432, APTA, Innovator's Fund


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
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.
progressive multi-component intervention
(Active Comparator)
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.
usual care

Primary Outcomes

Gait Speed
time frame: 60 days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Improving Activity, Participation And Function After Acute Hospitalization In Older Adults With Multiple Chronic Conditions: Phase II Randomized Controlled Trial
Principal investigator Jennifer E Stevens-Lapsley, PT, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.