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Clinical Trials/NCT02905370
NCT02905370CompletedNot Applicable

Progressing Home Health Rehabilitation Paradigms for Older Adults

University of Colorado, Denver2 sites in 1 country353 target enrollmentStarted: September 28, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
353
Locations
2
Primary Endpoint
Short Physical Performance Battery (SPPB)

Study Overview

Brief Summary

This research study explores the effects of a progressive, multi-component intervention following a stay in the hospital or rehabilitation facility. The purpose of this research study is to compare a multi-component intervention (higher intensity exercise, nutritional supplementation, and greater emphasis on functionally enhanced care transitions) with usual care physical therapy.

Detailed Description

Declines in physical function as a result of acute illness are strongly and independently associated with a number of adverse health events for older adults. Home Health (HH) physical therapy may be the ideal venue for addressing these declines in physical function because around 3 million older adults receive HH services following discharge from acute or post-acute facilities. However, as currently structured, HH care does not appear to adequately restore function, as evidenced by poor long-term outcomes and high rates of hospital readmission. Diminished physical function has been particularly implicated as a risk factor for re-hospitalization --older adults with lower levels of ambulatory activity are 6 times more likely to be re-hospitalized than those with greater ambulatory activity. A more intensive approach to HH physical therapy for older adults has great potential to maximize physical function and reduce hospital readmissions. Therefore, the investigators have developed a high intensity home-based, progressive, interdisciplinary, multi-component (PMC) intervention that directly addresses the functional deficits seen after hospitalization. This intervention will include intensive rehabilitation, a care transitions program, and daily protein supplementation. The investigators will conduct a two-arm, randomized clinical trial (RCT) of 200 participants admitted to HH from an acute or post-acute facility. Participants will receive either 1) an intensive, PMC intervention using resistance exercise and evidenced-based motor control training to improve physical function, along with nutritional supplementation and emphasis on functionally enhanced care transitions or 2) usual care (UC) physical therapy. The primary goal of this investigation is to determine if PMC intervention, initiated upon admission to HH, improves physical function, as measured by performance and self-report assessments, more than UC physical therapy. The investigators will also examine the effects on fatigue, balance confidence, and activities of daily living. In an exploratory analysis, the effects of the PMC intervention on re-hospitalization rates, nursing home placement, emergency room visits, and falls after discharge from the acute care hospital will also be examined. All outcomes will be examined at baseline, 30, 60 (primary endpoint), 90 and 180 days. If successful in improving patient function and decreasing re-hospitalization rates, PMC intervention holds potential for future health care cost savings.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 100 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 65 years of age and older
  • Referred to home care physical therapy following acute medical deconditioning
  • Have at least 3 comorbid conditions including those listed below:
  • Chronic Obstructive Pulmonary Disease
  • Gastrointestinal Bleed
  • Urinary Tract Infection
  • Pneumonia
  • Chronic ulcerative wounds
  • Hypertension
  • Depression/mental health
  • Irritable Bowel Syndrome
  • Post-op pancreatic surgery
  • Osteoporosis/OA/RA/Gout
  • Heart Disease
  • Hypercholesterolemia
  • Peripheral Arterial Disease
  • Spinal Stenosis
  • Dehydration
  • Atrial fibrillation
  • Hypo/Hyperthyroid
  • Renal Failure (no dialysis)
  • Post-op bowel surgery
  • Congestive Heart Failure
  • Be ambulatory without human assistance prior to hospitalization
  • Be English-speaking

Exclusion Criteria

  • (one or more):
  • Acute lower extremity fracture with weight-bearing restriction
  • "Elective" joint replacement surgery
  • Lower extremity amputation
  • Acute cardiac surgery
  • Terminal illness
  • Active cancer treatment in which exercise is contraindicated
  • Deep vein thrombosis/pulmonary embolus (DVT/PE)
  • Recent stroke (within 1 yr)
  • Score of <20 on SLUMS (as of 08.16.2018, revised to exclusion #14)
  • Inability to ambulate 10 feet without human assistance at time of hospital discharge
  • Gait Speed <0.3m/s or >1.0 m/s
  • Progressive neurodegenerative diagnosis (e.g. Parkinson's, MS, ALS)
  • Use of illegal substances
  • Clinical discretion of study physician to exclude patients who are determined to be unsafe and/or inappropriate to participate in high intensity rehabilitation as defined by the inclusion/exclusion criteria
  • Active involvement of Adult Protection Services
  • Current dialysis treatment
  • Prisoners or those on probation or other alternative sentencing

Outcomes

Primary Outcomes

Short Physical Performance Battery (SPPB)

Time Frame: Change in SPPB from baseline to 60 days post randomization

SPPB is a well-accepted global measure of lower extremity function which consists of walking speed, chair stands, and balance. It is a well-studied composite measure and a strong predictor of disability, institutionalization, and morbidity in older adults. SPPB will also be assessed at 30, 90, 180 days post-randomization.

Secondary Outcomes

  • ActivPAL(Change in physical activity from baseline to 60 days post randomization)
  • Falls Efficacy Scale-International(Change in Falls Efficacy Scale-International from baseline to 60 days post randomization)
  • Fatigue Severity Scale (FSS)(Change in FSS from baseline to 60 days post randomization)
  • Modified Physical Performance Test (mPPT)(Change in mPPT from baseline to 60 days post randomization)
  • Patient Activation Measure (PAM)(Change in PAM from baseline to 60 days post randomization)
  • Fast walking speed (4MW)(Change in 4MW from baseline to 60 days post randomization)
  • Grip Strength(Change in Grip Strength from baseline to 60 days post randomization)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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