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CompletedNCT00951691Updated Mar 19, 2014

Enhanced Medical Rehabilitation for Disablement

A Phase 2 interventional study of Enhanced acute medical rehabilitation and Treatment as usual in Hip Fracture and Depression, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2014-03-19.

Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study summary

This study will develop and test a new program of enhanced medical rehabilitation for elderly people who have had an acute disabling medical event and are admitted to a skilled nursing facility for post-acute rehabilitation.

Read the detailed description

Disabling medical events are common for elderly people, causing immobilization, requiring extensive rehabilitation, and generating fears of loss of function and need for institutionalization. Existing acute medical rehabilitation settings-skilled nursing facilities (SNFs) and inpatient rehabilitation facilities (IRFs)-often do not adequately meet the needs of depressed elders, resulting in a missed opportunity for effective and functional recovery. This study will test a new program that will enhance acute rehabilitation in SNFs to target mood, motivation, and functional recovery in the 2 to 4 weeks after hospitalization. This program, developed by the research team, increases the intensity and engagement of physical therapy (PT) and occupational therapy (OT).

Participation in this study will last until discharge from the SNF, with follow-up assessments lasting until 3 months after entry. Participants will be randomly assigned to receive either the enhanced acute medical rehabilitation or treatment as usual. Participants receiving the enhanced care will complete up to 3 hours of enhanced PT and OT per day from study entry until discharge, excluding weekends. Participants receiving treatment as usual will receive standard PT and OT. Study assessments will take place at baseline, after 8 and 15 days, and after discharge. Follow-up assessments will occur after 30, 60, and 90 days. Assessments will include questionnaires and interviews measuring positive and negative affect, and functional impairment and disability.

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Conditions studied

  • Hip Fracture
  • Depression

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Keywords

  • Elderly
  • Acute Medical Rehabilitation
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In context

Hip Fractures

822 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.

This study's enrollment of 25 is below the median of 90 across 529 interventional studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Admitted to Barnes Extended Care nursing home
  • Acute disablement
  • (criterion dropped) Clinically depressive symptoms, including a score of 15 or greater on the Hamilton Depression Rating Scale (HAM-D) and depressed mood or anhedonia present more days than not since the fracture

Exclusion criteria

Exclusion Criteria:

  • Unable to provide informed consent due to dementia and severe persistent delirium
  • Inability to cooperate with the protocol
  • Cardiac or other medical instability that would preclude carrying out high intensity exercises
  • Language, visual, or hearing barriers to participation
  • Presence of pelvic fractures that do not involve the proximal femur
  • Presence of metastatic cancer, including cancer that causes a pathological fracture
  • Bilateral acute hip fractures
  • Lifetime psychosis or mania
  • Alcohol or substance dependence within 6 months, or current (prior to hip fracture) alcohol or substance abuse
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Enhanced acute medical rehabilitation

    Participants will receive enhanced acute medical rehabilitation.

    Behavioral: Enhanced acute medical rehabilitation

  • Active comparator
    Treatment as usual

    Participants will receive treatment as usual.

    Behavioral: Treatment as usual

Interventions

  • BehavioralEnhanced acute medical rehabilitation

    Daily up to 3-hour sessions of enhanced physical and occupational therapies (see Lenze et al, "Enhanced Medical Rehabilitation Increases Therapy Intensity and Engagement and Improves Functional Outcomes in Postacute Rehabilitation of Older Adults: A Randomized-Controlled Trial." J American Medical Director's Association, 2012 for details and outcome data.

  • BehavioralTreatment as usual

    Standard treatment with physical and occupational therapies

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What researchers measure

Primary outcomes

  1. functional recovery

    Barthel Index. Secondary Measures are gait speed and 6 minute walk.

    Time frame: baseline, end of nursing home admission

Secondary outcomes

  1. positive and negative affect

    13 items assessing positive and negative affect

    Time frame: Measured from baseline to SNF discharge

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Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
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References and documents

Publications

  • Hildebrand, Mary W. OTD; Host, Helen H. PhD; Binder, Ellen F. MD; Carpenter, Brian PhD; Freedland, Kenneth E. PhD; Morrow-Howell, Nancy PhD; Baum, Carolyn M. PhD; Doré, Peter MA; Lenze, Eric J. MD.
  • Lenze EJ, Host HH, Hildebrand MW, Morrow-Howell N, Carpenter B, Freedland KE, Baum CA, Dixon D, Dore P, Wendleton L, Binder EF. Enhanced medical rehabilitation increases therapy intensity and engagement and improves functional outcomes in postacute rehabilitation of older adults: a randomized-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):708-12. doi: 10.1016/j.jamda.2012.06.014. Epub 2012 Aug 3. PubMed 22863663 ↗
  • Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3. PubMed 34766330 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00951691
Lead sponsor
Washington University School of Medicine
Responsible party
Eric Lenze (Professor of Psychiatry, Washington University School of Medicine) — Principal investigator
First posted
Aug 4, 2009
Start date
Aug 2009
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Mar 19, 2014

Study contacts

Eric J Lenze, MD
principal investigator · Washington University School of Medicine
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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