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

NCT ID: NCT01872637

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-05-31

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.

Conditions

Frail Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Progressive Multi-Component Intervention

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Interventions

Progressive Multi-Component Intervention

Intervention Type: BEHAVIORAL

Usual Care

Intervention Type: BEHAVIORAL

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
• dialysis
• hospice care

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcadia University

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer E Stevens-Lapsley, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Kate Mangione, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Arcadia University

Locations

University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, United States

Arcadia University

Glenside, Pennsylvania, United States

Countries

United States

Other Identifiers

Innovator's Fund

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

APTA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

10-0432

Identifier Type: -

Identifier Source: org_study_id