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

NCT01872637 | Completed

• 3 other identifiers: 10-0432Innovator's FundAPTA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Frail Older Adults

Outcome Measures

Primary Outcomes (1)

• Gait Speed

  Time it takes to walk a 4 meter path, key to independent functioning

  60 days

Secondary Outcomes (2)

• Modified Physical Performance Test (mPPT)

  60 days

• Late-Life Function and Disability Instrument (LLFDI)

  60 days

Study Arms (2)

Progressive Multi-Component Intervention

EXPERIMENTAL

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

Usual Care Group

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.

Behavioral: Usual Care

Interventions

Progressive Multi-Component Intervention BEHAVIORAL

Progressive Multi-Component Intervention

Usual Care BEHAVIORAL

Usual Care Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years or older
• referred to home care physical therapy
• have at least 3 comorbid conditions
• ambulatory without human assistance prior to hospitalization

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Arcadia University: collaborator

Study Sites (2)

University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Arcadia University

Glenside, Pennsylvania, 19038, United States

Location

Study Officials

• Jennifer E Stevens-Lapsley, PT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Kate Mangione, PT, PhD

  Arcadia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 7, 2013
• Study Start: June 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

US (2)