CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Functional Assessment +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT01943773
NCT01943773N/ACompleted

Functional Prehabilitation and Major Elective Surgery

University of Colorado, Denver·interventional·Posted Sep 17, 2013·Updated Jul 16, 2015

In Brief

A clinical study evaluating Functional Assessment and Prehabilitation for Surgical Complication and 2 related conditions. Completed, enrolled 16 participants across 2 sites.

Detailed Summary

Purpose: To compare post-operative functional outcomes in patients undergoing preoperative functional prehabilitation versus standard of care preoperative management in older adults undergoing major elective operations. Hypothesis: Older adults undergoing preoperative functional prehabilitation (nine sessions of home physical therapy over three weeks) will have improved physical function and reduced delirium in comparison to usual preoperative care following major abdominal and thoracic operations. Specific Aims: (#1) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the de Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical performance battery scores in the control and intervention groups at the preoperative and initial assessment timepoints. (#2) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the de Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical performance battery scores in the control and intervention groups at the 60-days postoperative and the initial assessment timepoints. (#3)To compare the rates of ICU delirium and need for post-discharge institutionalization in patients in the control and interventions groups. (#4) To compare post-operative complications

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 17, 2013
Enrollment StartMar 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.8 years ago

Interventions

Functional Assessmentprocedure

Both arms of the study will undergo functional assessments at three points during the study progress. BASELINE ASSESSMENT: On study entry, each participant will have a timed up-and-go, Mini Mental Status Exam, de Morton, Modified Physical Performance Test (MPPT), and a short physical performance battery performed. ASSESSMENT OF INTERVENTION EFFECTIVENESS: Immediately prior to the operation, all participants will undergo repeat testing. The difference in scores between the preoperative assessment and the initial assessment at enrollment will be compared in the control and intervention groups. POST-OPERATIVE ASSESSMENT: Repeat testing will be performed 60 days following the operation.

Prehabilitationprocedure

The intervention will consist of nine 45 minute long physical therapy sessions.