Functional Prehabilitation and Major Elective Surgery

NCT01943773 | Completed

• 1 other identifier: 12-1590
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

delirium; surgery; operation; geriatric; complication

Outcome Measures

Primary Outcomes (1)

• Post-operative Functional Assessment

  Timed up-and-go score 60 days post operatively.

  60 days post-operatively

Secondary Outcomes (3)

• Discharge status

  Discharge from hospital, expected to be 7 days

• Post-operative complications

  30 days post-operatively

• Functional and mental battery scores postoperatively

  60 days postoperatively

Study Arms (2)

Prehabilitation

EXPERIMENTAL

The intervention will consist of nine 45 minute long physical therapy sessions. Sessions will occur three times weekly at the patient's home.

Procedure: Functional Assessment; Procedure: Prehabilitation

No Prehabilitation

EXPERIMENTAL

The control group will undergo routine pre-operative management.

Procedure: Functional Assessment

Interventions

Functional Assessment PROCEDURE

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.

No Prehabilitation; Prehabilitation

Prehabilitation PROCEDURE

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

Prehabilitation

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 50 years and older undergoing major abdominal and non-cardiac thoracic operations with an anticipated postoperative ICU stay will be eligible for initial screening. A timed up-and-go assessment will be performed on all who individuals interested in participating. Individuals with a timed up-and-go score of greater than 10 seconds are eligible to participate.
• Women and men will both be recruited for the study. Minorities and non-minorities will be recruited for the study.

You may not qualify if:

• Participants under 50 years
• Patients not going to the ICU post-operatively
• Patients having a different kind of operation than major abdominal/non-cardiac thoracic
• Those who complete the timed up-and-go in 10 seconds or less or
• patients who cannot complete the timed up-and-go
• Patients who cannot undergo informed consent
• Patients with vision impairments who cannot visualize the pictures involved with the CAM-ICU
• Patients who do not speak English will be excluded so that confusion created by a language barrier is not confused with post-operative delirium.
• Pregnant women, prisoners, and decisionally challenged subjects.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Denver Veterans Affairs Medical Center

Denver, Colorado, 80221, United States

Location

Related Publications (4)

• Swank AM, Kachelman JB, Bibeau W, Quesada PM, Nyland J, Malkani A, Topp RV. Prehabilitation before total knee arthroplasty increases strength and function in older adults with severe osteoarthritis. J Strength Cond Res. 2011 Feb;25(2):318-25. doi: 10.1519/JSC.0b013e318202e431.

  PMID: 21217530 BACKGROUND

• Furze G, Dumville JC, Miles JN, Irvine K, Thompson DR, Lewin RJ. "Prehabilitation" prior to CABG surgery improves physical functioning and depression. Int J Cardiol. 2009 Feb 6;132(1):51-8. doi: 10.1016/j.ijcard.2008.06.001. Epub 2008 Aug 15.

  PMID: 18703241 BACKGROUND

• Carli F, Zavorsky GS. Optimizing functional exercise capacity in the elderly surgical population. Curr Opin Clin Nutr Metab Care. 2005 Jan;8(1):23-32. doi: 10.1097/00075197-200501000-00005.

  PMID: 15585997 BACKGROUND

• Robinson TN, Raeburn CD, Tran ZV, Angles EM, Brenner LA, Moss M. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009 Jan;249(1):173-8. doi: 10.1097/SLA.0b013e31818e4776.

  PMID: 19106695 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Thomas N Robinson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: September 17, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

US (2)