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Functional Prehabilitation and Major Elective Surgery

NCT01943773 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-07-16

No results posted yet for this study

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

Conditions

  • Surgical Complication
  • Physical Therapy
  • Timed Up and Go

Interventions

PROCEDURE

Functional Assessment

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.

PROCEDURE

Prehabilitation

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

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Thomas N Robinson, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01943773 on ClinicalTrials.gov